An open-label extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with RMS

2023-507906-15-00 Protocol COMB157G2399 Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 30 Jan 2019 · Status Ongoing, recruitment ended · 21 EU/EEA countries · 115 sites · Protocol COMB157G2399

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 1,894
Countries 21
Sites 115

Relapsing multiple sclerosis (RMS)

Evaluate the long-term safety and tolerability of ofatumumab 20 mg sc once every 4 weeks in subjects with RMS from the first dose of ofatumumab

Key facts

Sponsor
Novartis Pharma AG
Participant type
Patients
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10]
Trial duration
30 Jan 2019 → ongoing
Decision date (initial)
2024-07-23
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Novartis Pharma AG

External identifiers

EU CT number
2023-507906-15-00
EudraCT number
2017-004703-51

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

Evaluate the long-term safety and tolerability of ofatumumab 20 mg sc once every 4 weeks in subjects with RMS from the first dose of ofatumumab

Secondary objectives 4

  1. Describe long-term efficacy of ofatumumab 20 mg sc once every 4 weeks in subjects with RMS from the first dose of ofatumumab
  2. For subjects originally in COMB157G2301 and COMB157G2302 studies compare long-term outcomes in those who were immediately treated with ofatumumab versus delayed use of ofatumumab (i.e. after teriflunomide treatment in the COMB157G2301 and COMB157G2302 studies), by analyzing subjects according to their randomized treatment in COMB157G2301 and COMB157G2302 studies
  3. For subjects randomized to teriflunomide in COMB157G2301 and COMB157G2302 studies and switched to ofatumumab in the COMB157G2399 compare both periods before and after the switch to ofatumumab
  4. Explore the long-term health outcomes in subjects with RMS treated with ofatumumab 20 mg sc once every 4 weeks from the first dose of ofatumumab

Conditions and MedDRA coding

Relapsing multiple sclerosis (RMS)

VersionLevelCodeTermSystem organ class
20.0 PT 10048393 Multiple sclerosis relapse 100000004852

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Must have participated in a Novartis MS study: • which dosed ofatumumab 20 mg sc q4 weeks, • was an adult (≥ 18 years of age) study in RMS, • must have completed the study on study treatment
  2. 2. Written informed consent

Exclusion criteria 9

  1. Premature discontinuation from previous ofatumumab study or from study treatment in previous ofatumumab study
  2. Subjects that have had their previous ofatumumab study end of study (EOS) > 6 months prior to screening and/or been given another MS disease-modifying therapy (DMT) between EOS of previous study and screening of this study
  3. Less than 3.5-month washout of teriflunomide for subjects that will not complete the accelerated elimination procedure (AEP) prior to Day 1. Only applicable to subjects completing studies COMB157G2301 and COMB157G2302
  4. Subjects with a history of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator
  5. Subjects that have any unresolved adverse event (AE) or condition from the previous study that necessitates temporary interruption of the study treatment, until such time as the event or condition has resolved (the subject will be monitored within the safety follow-up (SFU) of the previous study during this time)
  6. Emergence of any clinically significant condition/disease during previous ofatumumab study in which study participation might result in safety risk for subjects
  7. Subjects with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML
  8. Subjects with active systemic bacterial, viral or fungal infections, or chronic infection (e.g. Acquired Immune Deficiency Syndrome (AIDS))
  9. Subjects that have developed or have had reactivation of syphilis or tuberculosis during previous ofatumumab study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

  1. Proportion of subjects with adverse events
  2. Proportion of subjects with laboratory, or vital signs results meeting abnormal criteria
  3. Proportion of subjects with electrocardiogram (ECG) meeting abnormal criteria [through Week 240 (EOS)]
  4. Proportion of subjects meeting predefined criteria in Columbia Suicide Severity Rating Scale (C SSRS) [through Week 240/EOS]

Secondary endpoints 17

  1. Through Week 240/EOS: • Annualized Relapse Rate (ARR)
  2. Through Week 240/EOS: • Time to first relapse
  3. Through Week 240/EOS: • Time to 3-month Confirmed Disability Worsening (3mCDW)
  4. Through Week 240/EOS: • Time to 6-month Confirmed Disability Worsening (6mCDW)
  5. Through Week 240/EOS: • Time to 6-month Confirmed Disability Improvement (6mCDI)
  6. Through Week 240/EOS: • Time to 12-month Confirmed Disability Improvement (12mCDI)
  7. Through Week 240/EOS: • Time to 24-month Confirmed Disability Improvement (24mCDI)
  8. Through Week 240/EOS: • Time to 6-month Confirmed Disability Improvement (6mCDI) sustained until End of Study (EOS)
  9. Through Week 240/EOS: • Change in Expanded Disability Status Scale (EDSS)
  10. Through Week 240/EOS: • Time to 6-month confirmed 4-point worsening on Symbol Digit Modalities Test (SDMT)
  11. Through Week 240/EOS: • Change in SDMT
  12. Through Week 240/EOS: • Annualized T2 lesion rate
  13. Through Week 240/EOS: • Number of T1 Gd-enhancing lesions per Magnetic Resonance Image (MRI) scan
  14. Through Week 240/EOS: • Annual rate of change in brain volume
  15. Through Week 240/EOS: • Change in neurofilament light chain (NfL) concentration in serum
  16. Through Week 240/EOS: • Relationship between NFL and disease activity, disease course and treatment response
  17. Through Week 240/EOS: • Patient Reported Outcomes (PRO)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 31

BOOSTRIX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique et coquelucheux (acellulaire multicomposé), (adsorbé, à teneur réduite en antigènes)

PRD7807172 · Product

Active substance
Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
34009 301 951 2 3
MA holder
LABORATOIRE GLAXOSMITHKLINE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Boostrix szuszpenziós injekció előretöltött fecskendőben diphtheria, tetanus és pertussis (acelluláris összetevő) vakcina (adszorbeált, csökkentett antigén tartalmú)

PRD1609557 · Product

Active substance
Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
OGYI-T-20490/06
MA holder
GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Boostrix* Diphtherie-Tetanus-Pertussis (azellular)-Kombinationsimpfstoff zur Auffrischimpfung

PRD334973 · Product

Active substance
Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
PEI.H.00664.01.2
MA holder
GLAXOSMITHKLINE GMBH & CO. KG
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

BOOSTRIX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique et coquelucheux (acellulaire multicomposé), (adsorbé, à teneur réduite en antigènes)

PRD7807849 · Product

Active substance
Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
NL51775
MA holder
LABORATOIRE GLAXOSMITHKLINE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Boostrix Injektionssuspension in einer Fertigspritze Diphtherie-, Tetanus- und Pertussis (azellulär, aus Komponenten)-Adsorbatimpfstoff (mit reduziertem Antigengehalt)

PRD334956 · Product

Active substance
Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
PEI.H.00664.01.1
MA holder
GLAXOSMITHKLINE GMBH & CO. KG
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

BOOSTRIX, suspension injectable en seringue préremplie Vaccin diphtérique, tétanique et coquelucheux (acellulaire multicomposé), (adsorbé, à teneur réduite en antigènes)

PRD7807444 · Product

Active substance
Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
34009 301 951 3 0
MA holder
LABORATOIRE GLAXOSMITHKLINE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Boostrix szuszpenziós injekció előretöltött fecskendőben diphtheria, tetanus és pertussis (acelluláris összetevő) vakcina (adszorbeált, csökkentett antigén tartalmú)

PRD1609555 · Product

Active substance
Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
OGYI-T-20490/02
MA holder
GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Boostrix, suspenzija za injekciju u napunjenoj štrcaljki, cjepivo protiv difterije, tetanusa i pertusisa (nestanicno, komponentno), adsorbirano, smanjenog(ih) sadržaja antigena

PRD7853164 · Product

Active substance
Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
HR-H-889892563
MA holder
GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country
Croatia
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Boostrix szuszpenziós injekció eloretöltött fecskendoben diphtheria, tetanus és pertussis (acelluláris összetevo) vakcina (adszorbeált, csökkentett antigén tartalmú)

PRD343350 · Product

Active substance
Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
OGYI-T-20490/01
MA holder
GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Boostrix suspensión inyectable en jeringa precargada Vacuna antidiftérica, antitetánica y antitos ferina (componente acelular) (adsorbida, contenido antigénico reducido)

PRD334803 · Product

Active substance
Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
63.684
MA holder
GLAXOSMITHKLINE, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Boostrix zawiesina do wstrzykiwań w ampułko-strzykawce|Szczepionka przeciw błonicy, tężcowi i krztuścowi (bezkomórkowa, złożona), adsorbowana, o|zmniejszonej zawartości antygenów

PRD352202 · Product

Active substance
Diphtheria Toxoid Adsorbed on Aluminium Hydroxide, Hydrated and Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AJ52 — PERTUSSIS, PURIFIED ANTIGEN, COMBINATIONS WITH TOXOIDS
Marketing authorisation
14239
MA holder
GLAXOSMITHKLINE BIOLOGICALS S.A.
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

PRD7443639 · Product

Active substance
BPHUKET30732013-LIKE Virus (BSINGAPOREINFTT-16-06102016, Wild Type)
Substance synonyms
B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type)
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07BB02 — INFLUENZA, PURIFIED ANTIGEN
Marketing authorisation
EU/1/18/1326/003
MA holder
SEQIRUS NETHERLANDS B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

PRD7443645 · Product

Active substance
BPHUKET30732013-LIKE Virus (BSINGAPOREINFTT-16-06102016, Wild Type)
Substance synonyms
B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type)
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07BB02 — INFLUENZA, PURIFIED ANTIGEN
Marketing authorisation
EU/1/18/1326/003
MA holder
SEQIRUS NETHERLANDS B.V.
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PNEUMOVAX solution injectable en flacon Vaccin pneumococcique polyosidique

PRD4585841 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
34009 355 281 7 9
MA holder
MSD FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pneumovax 23 oldatos injekció előretöltött fecskendőben Pneumococcus-poliszacharid vakcina

PRD3389220 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
OGYI-T-8718/04
MA holder
MSD PHARMA HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PNEUMOVAX solution injectable en flacon Vaccin pneumococcique polyosidique

PRD4585843 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
34009 355 282 3 0
MA holder
MSD FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pneumovax 23 oldatos injekció előretöltött fecskendőben Pneumococcus-poliszacharid vakcina

PRD3389224 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
OGYI-T-8718/08
MA holder
MSD PHARMA HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pneumovax 23 oldatos injekció előretöltött fecskendőben Pneumococcus-poliszacharid vakcina

PRD3389223 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
OGYI-T-8718/07
MA holder
MSD PHARMA HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pneumovax 23 oldatos injekció előretöltött fecskendőben Pneumococcus-poliszacharid vakcina

PRD3389221 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
OGYI-T-8718/05
MA holder
MSD PHARMA HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pneumovax 23 otopina za injekciju u napunjenoj štrcaljki Cjepivo protiv pneumokoka, polisaharidno

PRD6973424 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
HR-H-805570349
MA holder
MERCK SHARP & DOHME D.O.O.
MA country
Croatia
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PNEUMOVAX 23 Szczepionka przeciw pneumokokom, polisacharydowa, roztwór do wstrzykiwań

PRD405302 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
R/6904
MA holder
MSD POLSKA SP. Z O.O.
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pneumovax 23 oldatos injekció Pneumococcus-poliszacharid vakcina

PRD405320 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
OGYI-T-8718/02
MA holder
MSD PHARMA HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PNEUMOVAX 23 Solución inyectable en vial Vacuna antineumocócica de polisacáridos

PRD4585879 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
63.828
MA holder
MERCK SHARP & DOHME DE ESPANA S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pneumovax 23 oldatos injekció előretöltött fecskendőben Pneumococcus-poliszacharid vakcina

PRD3389222 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
OGYI-T-8718/06
MA holder
MSD PHARMA HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pneumovax 23 oldatos injekció Pneumococcus-poliszacharid vakcina

PRD372573 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
OGYI-T-8718/01
MA holder
MSD PHARMA HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pneumovax 23 oldatos injekció előretöltött fecskendőben Pneumococcus-poliszacharid vakcina

PRD3389219 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
OGYI-T-8718/03
MA holder
MSD PHARMA HUNGARY KFT.
MA country
Hungary
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PNEUMOVAX solution injectable en flacon Vaccin pneumococcique polyosidique

PRD4585842 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
34009 355 280 0 1
MA holder
MSD FRANCE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PNEUMOVAX 23 Injektionslösung in einer Durchstechflasche Pneumokokken-Polysaccharid-Impfstoff

PRD4585875 · Product

Active substance
Pneumococcal Polysaccharide Serotype 4
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
Marketing authorisation
PEI.H.01834.01.2
MA holder
MSD SHARP & DOHME GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Kesimpta 20 mg solution for injection in pre-filled pen

PRD8833240 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
1960 mg milligram(s)
Max treatment duration
96 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/003
MA holder
NOVARTIS IRELAND LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Clinical variant of the approved product

Kesimpta 20 mg solution for injection in pre-filled pen

PRD8833245 · Product

Active substance
Ofatumumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
20 mg milligram(s)
Max total dose
1960 mg milligram(s)
Max treatment duration
96 Month(s)
Authorisation status
Authorised
ATC code
L04AG12 — -
Marketing authorisation
EU/1/21/1532/004
MA holder
NOVARTIS IRELAND LIMITED
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Clinical variant of the approved product

Prevenar 13 suspension for injection in single dose vial pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

PRD1703872 · Product

Active substance
Pneumococcal Polysaccharide Serotype 1 Conjugated to CRM197 Adsorbed on Aluminium Phosphate
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
INTRAMUSCULAR INJECTION
Max daily dose
0.5 ml millilitre(s)
Max total dose
0.5 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J07AL02 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED
Marketing authorisation
EU/1/09/590/010
MA holder
PFIZER EUROPE MA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

220 Total trials 69 Recruiting 130 Ended
Commercial
Sponsor organisation
Novartis Pharma AG
Address
Lichtstrasse 35
City
Basel
Postcode
4056
Country
Switzerland

Scientific contact point

Organisation
Novartis Pharma AG
Contact name
Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation
Novartis Pharma AG
Contact name
Novartis Pharma Arzneimittel GmbH

Third parties 28

OrganisationCity, countryDuties
Medical Intertrade d.o.o.
ORG-100001426
 Sveta Nedelja, Croatia Other
Oribalt Riga SIA
ORG-100012153
 Marupe, Latvia Other
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland On site monitoring
Mag. Andreas Raffeiner GmbH
ORG-100043223
 Walding, Austria Code 8
Clinical Ink Inc.
ORG-100042433
 Horsham, United States Other
PRA Hellas CRO A.E.
ORG-100048208
 Nea Ionia, Greece On site monitoring
Creapharm Clinical Supplies
ORG-100020131
 Reims, France Other
MIAC AG
ORG-100043228
 Basel Town, Switzerland Code 13, Other
Oribalt Vilnius UAB
ORG-100022127
 Vilnius, Lithuania Other
Statmed Sp. z o.o.
ORG-100047187
 Golkow, Poland Other
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Other, Laboratory analysis
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Specific Pharma A/S
ORG-100015041
 Copenhagen Sv, Denmark Other
Eco-Abc Sp. z o. o.
ORG-100046253
 Belchatow, Poland Other
Universitaetsspital Basel
ORG-100030708
 Basel, Switzerland Other
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States Other
Abf Pharmaceutical Services GmbH
ORG-100014752
 Vienna, Austria Other
IQVIA Limited
ORG-100008655
 Reading, United Kingdom On site monitoring
Parexel International (IRL) Limited
ORG-100022780
 Dublin 2, Ireland Code 12
Syneos Health Inc.
ORG-100008382
 Morrisville, United States On site monitoring
Medical Equipment Supplies And Management Limited
ORG-100044212
 Chorley, United Kingdom Other
Freja Transport & Logistics AS
ORG-100018845
 Frogner, Norway Other
Apoteket AB
ORG-100021562
 Solna, Sweden Code 14
Siemens Healthcare Laboratory LLC
ORG-100051237
 Berkeley, United States Other
Opt-X-Pense Kft.
ORG-100047138
 Budaors, Hungary Other
Neurorx Research Inc.
ORG-100046079
 Montreal, Canada Other
Avantor Inc.
ORG-100050885
 Claremont, United States Other
ADR Logistics Kft.
ORG-100045267
 Budaors, Hungary Code 14, Other

Locations

21 EU/EEA countries · 115 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ended 33 1
Belgium Ongoing, recruitment ended 15 4
Bulgaria Ongoing, recruitment ended 68 6
Croatia Ongoing, recruitment ended 63 5
Czechia Ongoing, recruitment ended 137 10
Denmark Ongoing, recruitment ended 9 2
Estonia Ongoing, recruitment ended 29 2
Finland Ongoing, recruitment ended 2 2
France Ongoing, recruitment ended 16 7
Germany Ongoing, recruitment ended 49 13
Greece Ongoing, recruitment ended 5 2
Hungary Ongoing, recruitment ended 38 7
Latvia Ongoing, recruitment ended 23 3
Lithuania Ongoing, recruitment ended 28 2
Netherlands Ongoing, recruitment ended 11 3
Norway Ongoing, recruitment ended 2 1
Poland Ongoing, recruitment ended 253 12
Portugal Ongoing, recruitment ended 31 6
Slovakia Ongoing, recruitment ended 16 7
Spain Ongoing, recruitment ended 131 18
Sweden Ongoing, recruitment ended 4 2
Rest of world
Turkey, Argentina, Canada, Switzerland, United Kingdom, Japan, United States, South Africa, Peru, Thailand, India, Israel, Australia, Russian Federation, Taiwan, Mexico
 — 931 —

Investigational sites

Austria

1 site · Ended
Medical University Of Vienna
#7601: Department of Neurology, Waehringer Guertel 18-20, Alsergrund, Vienna

Belgium

4 sites · Ongoing, recruitment ended
Antwerp University Hospital
#7506: Neurologie, Drie Eikenstraat 655, 2650, Edegem
Az St-Jan Brugge-Oostende A.V.
#7500: Neurologie, Ruddershove 10, 8000, Brugge
Universitair Ziekenhuis Gent
#7505: Neurologie, Corneel Heymanslaan 10, 9000, Gent
Universite Catholique de Louvain
#7504: Neurologie, Hippokrateslaan 54, Ucl 5471, Sint-Lambrechts-Woluwe

Bulgaria

6 sites · Ongoing, recruitment ended
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
#7404: Neurology clinic, Ulitsa Georgi Kochev 8-A, 5803, Pleven
MHAT National Heart Hospital EAD
#7403: Clinic of Neurology diseases, Ulitsa Konyovitsa 65, 1309, Sofiya
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
#7401: Clinic of Neurology diseases, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
Medical Center Medconsult Pleven OOD
#7405, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
#7400: Clinic of nervous diseases for movement disorders, Ulitsa Dr Lyuben Rusev 1, 1113, Sofia
Alexandrovska University Hospital
#7402: Clinic of Neurology diseases, Georgy Sofiiski Str 1, 1431, Sofia

Croatia

5 sites · Ongoing, recruitment ended
Klinicki Bolnicki Centar Osijek
#7304: neurology, Ulica Josipa Huttlera 4, 31000, Osijek
KBC Zagreb
#7303: neurology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Victus Polyclinic
#7300: neurology, Ulica Kneza Mislava 15, 10000, Zagreb
KBC Zagreb
#7302: neurology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Clinical Hospital Centre Rijeka
#7301: neurology, Kresimirova 42, 51000, Rijeka

Czechia

10 sites · Ongoing, recruitment ended
Fakultni Nemocnice U Sv Anny V Brne
#7204: Neurologická klinika, Pekarska 53, Stare Brno, Brno-Stred
Vseobecna Fakultni Nemocnice V Praze
#7207: MS Centrum, Karlovo Namesti 554/32, Nove Mesto, Prague 2
Nemocnice Jihlava prispevkova organizace
#7210: Neurologická klinika, Vrchlickeho 4630/59, 586 01, Jihlava 1
Neurospol s.r.o.
#7200: Neurologie, Kubinova 964/27, Hermanice, Slezska Ostrava
Nemocnice Pardubickeho kraje a.s.
#7203: Neurologické oddělení, Kyjevska 44 Pardubicky, 530 03, Pardubice
University Hospital Olomouc
#7209: Neurologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Krajska zdravotni a.s.
#7202: Neurologické oddělení, Duchcovska 53, 415 01, Teplice
Fakultni Nemocnice Hradec Kralove
#7201: Neurologická klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Thomayerova nemocnice
#7206: Neurologická klnika, Videnska 750/800, Krc, Prague 4
Fakultni Nemocnice Kralovske Vinohrady
#7208: Neurologická klinika, Srobarova 1150/50, Vinohrady, Prague 10

Denmark

2 sites · Ongoing, recruitment ended
Rigshospitalet
7101: Neurologisk afdeling, Valdemar Hansens Vej 1-23, 2600, Glostrup
Odense University Hospital
7100: Neurologisk Afdeling, Sklerosekliniken, J B Winsloews Vej 4, 5000, Odense C

Estonia

2 sites · Ongoing, recruitment ended
Laane-Tallinna Keskhaigla AS
#7000:Neurology Centre, Paldiski Mnt 68, 10617, Pohja-Tallinna Linnaosa
Tartu University Hospital
#7001:Department of Neurology and Neurosurgery, L. Puusepa Tn 1a, 50406, Tartu Linn

Finland

2 sites · Ongoing, recruitment ended
Mehilaeinen Oy
6900: Neuro Neo Turku, Pohjoinen Hesperiankatu 17 C, 00260, Helsinki
Suomen Terveystalo Oy
6901: General Practice, Rautatienkatu 27, 33100, Tampere

France

7 sites · Ongoing, recruitment ended
Centre Hospitalier Universitaire De Montpellier
6801: Neurology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Lille
6804: Neurology, Rue Emile Laine, 59037, Lille Cedex
Centre Hospitalier Universitaire De Nice
6802: Neurology, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Nantes
6800: Neurology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Les Hopitaux Universitaires De Strasbourg
6803: Neurology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Nimes
6805: Neurology, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Hopital Universitaire Pitie Salpetriere
6807: Neurology, 47 Boulevard De L Hopital, 75651, Paris Cedex 13

Germany

13 sites · Ongoing, recruitment ended
Klinikum Bayreuth GmbH
6713: Hohe Warte, Neurologische Klinik, Hohe Warte 8, Gruener Baum, Bayreuth
Universitaetsklinikum Heidelberg AöR
6703: Neurologische Klinik Uniklinik Heidelberg, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
Universitaet Leipzig
6711: Klinik und Poliklinik fur Neurologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen
6701: ZNS GmbH, Weidenauer Strasse 120, Weidenau, Siegen
Universitaetsklinikum Giessen und Marburg GmbH
6717: Klinik und Poliklinik für Neurologie, Baldingerstrasse 1, 35043, Marburg
MultipEL Studies
6723: Private Practice, Bengelsdorfstr. 5, 22179, Hamburg
Universitaetsklinikum Essen AöR
6708: Universitatsklinikum Essen (AoR9) Klinik für Neurologie, Hufelandstrasse 55, Holsterhausen, Essen
Universitaet Leipzig
#6711: Klinik und Poliklinik fur Neurologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
St. Josef-Hospital
6706: Alexianer St. Josef Potsdam GmbH, Klinik fur Neurologie, Allee Nach Sanssouci 7, Brandenburger Vorstadt, Potsdam
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
6700: Klinik und Poliklinik für Neurologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Neurozentrum Bielefeld
6702: Neurozentrum Bielefeld, Hauptstr 117, 33647, Bielefeld
Klinikum der Universitaet Muenchen AöR
6714: Institut für Klinische Neuroimmunologie, Marchioninistrasse 15, Hadern, Munich
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
6704: Neuropoint GmbH, Muensterplatz 32, Mitte, Ulm

Greece

2 sites · Ongoing, recruitment ended
University General Hospital Of Thessaloniki Ahepa
#6602: B’ Neurology Clinic, 1st St Kiriakidis Str, 546 36, Thessaloniki
401 General Military Hospital Of Athens
#6600: Neurology Department, Panagioti Kanellopoulou Av 1, 115 25, Athens

Hungary

7 sites · Ongoing, recruitment ended
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
#6501, Maglodi Ut 89-91, Kerulet, Budapest
University Of Szeged
#6503: Neurologiai Klinika, Semmelweis Utca 6, 6725, Szeged
Kistarcsai Flor Ferenc Korhaz
#6500: Deparment of Neurology, Semmelweis Ter 1, 2143, Kistarcsa
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet
#6505, Koves Ut 1, 1204, Budapest
University Of Pecs
#6506: Neurologiai Klinika, Ret Utca 2, 7623, Pecs
Uno Medical Trials Kft.
#6502, Vecsey Karoly Utca 39, 1152, Budapest XV
S-Medicon Kft.
#6504, Megyeri Ut 53, 1044, Budapest IV

Latvia

3 sites · Ongoing, recruitment ended
Rigas Austrumu kliniska universitates slimnica SIA
6202, Hipokrata Iela 2, LV-1079, Riga
Latvijas Juras medicinas centrs AS
6201, Vecmilgravja 5. Linija 26, LV-1015, Riga
Pauls Stradins Clinical University Hospital
6200, Pilsonu Iela 13, 1002, Riga

Lithuania

2 sites · Ongoing, recruitment ended
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
#6100:neurology, Eiveniu G. 2, Kauno M. Sav., Kaunas
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
#6102:neurology, Santariskiu G 2, Vilniaus M. Sav., Vilnius

Netherlands

3 sites · Ongoing, recruitment ended
Zuyderland Medisch Centrum Stichting
#6001:Neurology, Dr. H. Van Der Hoffplein 1, 6162 BG, Geleen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
#6002:Neurology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Amsterdam UMC Stichting
#6000:Neurology, De Boelelaan 1117, 1081 HV, Amsterdam

Norway

1 site · Ongoing, recruitment ended
Drammen Sykehus
5900: Department of Neurology, Dronninggata 28, 3004, Drammen

Poland

12 sites · Ongoing, recruitment ended
Copernicus Podmiot Leczniczy Sp. z o.o.
#5803:Szpital św. Wojciecha Oddział Neurologiczny, Al. Jana Pawla II 50, 80-462, Gdansk
Ma-Lek Clinical Sp. z o.o.
#5801:Centrum Terapii SM, Ul. Zaleska 9, 40-571, Katowice
Centrum Medyczne Medyk Sp. z o.o. S.K.
#5812, Ul. Fryderyka Szopena 1, 35-055, Rzeszow
Neurocentrum Bydgoszcz Sp. z o.o.
#5806, Ul. Aleje Prof. Sylwestra Kaliskiego 28/U1, 85-796, Bydgoszcz
Resmedica Sp. z o.o.
#5802, Ul. Romualda Mielczarskiego 105/3-4, 25-726, Kielce
Uniwersyteckie Centrum Kliniczne
#5804: Klinika Neurologii Dorosłych, Ul. Debinki 7, 80-952, Gdansk
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
#5811:Oddział Neurologiczny, Ul. 3 Maja 13/15, 41-800, Zabrze
Copernicus Podmiot Leczniczy Sp. z o.o.
#5805:Szpital im. Mikołaja Kopernika Oddział Neurologiczny, Ul. Nowe Ogrody 1/6, 80-803, Gdansk
Wromedica I Bielicka A Strzalkowska s.c.
#5810, Ul. Adama Mickiewicza 91, 51-685, Wroclaw
Nowe Techniki Medyczne Szpital Specjalistyczny Imienia Swietej Rodziny Sp. z o.o.
#5813:Oddział Neurologiczny, Ul. Rudna Mala 600, Rudna Mala, Glogow Malopolski
Centrum Neurologii Krzysztof Selmaj
#5800, ul. Tylna 12, 90-324, Łódź
Instytut Psychiatrii I Neurologii
#5817:II Klinika Neurologiczna, Ul. Jana III Sobieskiego 9, 02-957, Warsaw

Portugal

6 sites · Ongoing, recruitment ended
Centro Hospitalar De Entre O Douro E Vouga E.P.E.
#5703: Serviço Neurologia, Rua Dr Candido De Pinho, 4520-211, Santa Maria Da Feira
CCAB Centro Clinico Academico Braga Associacao
#5701: Serviço Neurologia, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Coimbra E.P.E.
#5705: Serviço Neurologia, Praceta Professor Mota Pinto, 3004-561, Coimbra
Hospital Beatriz Angelo
#5704: Serviço Neurologia, Avenida Carlos Teixeira No 3, 2674-514, Loures
Hospital Da Luz S.A.
#5708: Serviço Neurologia, Avenida Lusiada 100, 1500-650, Lisbon
Unidade Local De Saude De Matosinhos E.P.E.
#5702: Serviço Neurologia, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora

Slovakia

7 sites · Ongoing, recruitment ended
University Hospital Bratislava
#5502: UNB Ružinov, Neurologická klinika, Ruzinovska 6, Ruzinov, Bratislava
Fakultna Nemocnica Trnava
#5503: Neurologické oddelenie, Andreja Zarnova 11, 917 02, Trnava
Univerzitna Nemocnica Martin
#5506: Neurologická klinika, Kollarova 2, 036 01, Martin
University Hospital Bratislava
#5500: Nem. Staré Mesto, Neurologická klinika, Mickiewiczova 13, Stare Mesto, Bratislava
University Hospital Bratislava
#5501: Nem. Ak. L.Dérera, II. Neurologická klinika, Limbova 5, Nove Mesto, Bratislava
Fakultna Nemocnica Nitra
#5504: Neurologicka klinika, Spitalska 6, Stare Mesto, Nitra
F D Roosevelt University General Hospital Of Banska Bystrica
#5505: II.Neurologická klinika SZÚ, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica

Spain

18 sites · Ongoing, recruitment ended
Bellvitge University Hospital
#5417 :neurologia, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Hospital Universitario De Cruces
#5403 :neurologia, Cruces Plaza S/n, 48903, Barakaldo
University Clinical Hospital Virgen De La Arrixaca
#5412 :neurologia, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Nisa Sevilla Aljarafe
#5418 :neurologia, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Universitario Quironsalud Madrid
#5400 :neurologia, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Virgen De La Macarena
#5402 :neurologia, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Santa Caterina Ias
#5410 :neurologia, Calle Del Doctor Castany S/N, 17190, Salt
Hospital De La Santa Creu I Sant Pau
#5416 :neurologia, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitari Vall D Hebron
#5409 :Unidad de Neuroinmunología Clínica, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Clinic De Barcelona
#5411 :neurologia, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Regional De Malaga
#5407 :neurologia, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario Y Politecnico La Fe
#5413 :neurologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
#5405 :neurologia, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Universitario De La Princesa
#5408 :neurologia, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Ramon Y Cajal
#5406 :neurologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Clinico San Carlos
#5401 :neurologia, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario Donostia
#5404 :neurologia, Pasealeku Doct. Begiristain 109, 20014, Donostia
Hospital Universitario Puerta Del Mar
#5415 :neurologia, Avenida De Ana De Viya 21, 11009, Cadiz

Sweden

2 sites · Ongoing, recruitment ended
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
#5301: MS Centrum, Bla Straket 5, 413 46, Goteborg
Region Stockholm – SLSO
#5300: Centrum för neurologi, Solnavagen 1 E, S:t Matteus, Stockholm

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2019-01-30 2025-10-29 2019-01-30 2024-09-05
Belgium 2019-05-27 2019-05-27 2024-09-05
Bulgaria 2019-04-23 2019-04-23 2024-09-05
Croatia 2019-06-17 2019-06-17 2024-09-05
Czechia 2019-04-17 2019-04-17 2024-09-05
Denmark 2019-06-17 2019-06-17 2024-09-05
Estonia 2019-04-23 2019-04-23 2024-09-05
Finland 2019-06-19 2019-06-19 2024-09-05
France 2019-04-24 2019-04-24 2024-09-05
Germany 2019-04-15 2019-04-15 2024-09-05
Greece 2019-08-02 2019-08-02 2024-09-05
Hungary 2019-04-16 2019-04-16 2024-09-05
Latvia 2019-04-23 2019-04-23 2024-09-05
Lithuania 2019-04-18 2019-04-18 2024-09-05
Netherlands 2019-05-01 2019-05-01 2024-09-05
Norway 2019-05-28 2019-05-28 2024-09-05
Poland 2019-06-07 2019-06-07 2024-09-05
Portugal 2019-05-27 2019-05-27 2024-09-05
Slovakia 2019-04-30 2019-04-30 2024-09-05
Spain 2019-04-29 2019-04-29 2024-09-05
Sweden 2019-04-29 2019-04-29 2024-09-05

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 170 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Post-text supplement 01_1_English_NonRed 02
Protocol (for publication) D1_Protocol - Signature Page_2023-507906-15-00_1_English_Red v04
Protocol (for publication) D1_Protocol_2023-507906-15-00_1_English_Red 4
Protocol (for publication) D1_Protocol_2023-507906-15-00_1_Greece_Red 4
Protocol (for publication) D4_Patient-facing document - Diary_1_English_Red 25Feb2025
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_AT_English_Note to Assesor_NonRed 29Jan2024
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_BE_English_Red 13Sep2024
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_BG_English_Note to Assesor_NonRed 00
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_CZ_English_Note to Assesor_NonRed 15Jan2025
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_DE_English_Note to Assesor_NonRed 22Aug2024
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_DK_English_NonRed_T v1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_EE_English_Note to Assesor_NonRed 01Oct2024
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_ES_English_Note to Assesor_NonRed 15Nov2024
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_FR_English_Note to Assesor_NonRed 15Jan2025
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_GR_English_Red 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_HR_French_Note to Assesor_NonRed 18Sep2024
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_HU_English_Note to Assesor_NonRed 03Sep2024
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_NL_English_Note to Assesor_NonRed v00
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_NO_English_NonRed 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_PT_English_Note to Assesor_NonRed 15Nov2024
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_SE_English_Note to Assesor_NonRed 15Jan2025
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_SK_English_Note to Assesor_NonRed v01
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Latvia_1_LV_English_NonRed 13Sep2024
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Lithuania_1_LT_English_NonRed 1Aug2024
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Poland_1_PL_English_Note to Assesor_NonRed 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_1_FI_English_Note to Assessor_NonRed 19Dec2024
Subject information and informed consent form (for publication) L1_ICF - Additional Biomarkers_1_CZ_Czech_NonRed v02.02.02
Subject information and informed consent form (for publication) L1_ICF - Additional Biomarkers_1_DE_German_NonRed 04.08.04
Subject information and informed consent form (for publication) L1_ICF - Additional Biomarkers_1_SE_Swedish_Red 02.02.00
Subject information and informed consent form (for publication) L1_ICF - Covid 19_1_FI_English_Note to Assessor_NonRed 30Jan2025
Subject information and informed consent form (for publication) L1_ICF - Covid 19_1_GR_English_Red 02.00.00
Subject information and informed consent form (for publication) L1_ICF - Covid 19_1_GR_Greek_Red 02.00.00
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_AT_German_NonRed 0.1
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_BE_Dutch_NonRed v0.0
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_BE_English_NonRed v0.0
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_BE_French_NonRed v0.0
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_BG_Bulgarian_NonRed 1
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_BG_English_NonRed 00.00
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_CZ_Czech_NonRed v2.0
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_DE_German_NonRed 04.00.01
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_DK_Danish_NonRed v2
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_EE_Estonian_NonRed v1.2
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_EE_Russian_NonRed v1.2
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed 23/07/2018
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_FI_Finnish_NonRed 00.00.02
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_FR_French_NonRed V00.00
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_HR_Croatian_NonRed v1.1
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_HU_Hungarian_NonRed v.00.00.02
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_LT_Lithuanian_NonRed v1.0
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_LV_Latvian_NonRed v01
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_LV_Russian_NonRed v01
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_NL_Dutch_NonRed V00000000
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_NO_Norwegian_NonRed v00.00.01
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_PL_Polish_NonRed v1
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_PT_Portuguese_NonRed 01.02
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_SE_Swedish_NonRed 1
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_1_SK_Slovak_NonRed V1
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant participant_2_HU_Hungarian_NonRed V1.1
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant partner of participant_1_DE_German_NonRed 00.00.00
Subject information and informed consent form (for publication) L1_ICF - Home Nursing Service_1_SE_Swedish_NonRed 02.02.00
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_AT_German_Red v04.08.07
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_BE_Dutch_Red v04.08.07
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_BE_English_Red v04.08.07
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_BE_French_Red v04.08.07
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_BG_Bulgarian_Red v04.08.14
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_BG_English_Red 04.08
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_CZ_Czech_Red v03.06.08
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_DE_German_Red 04.08.08
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_DK_Danish_Red V9
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_EE_Estonian_Red 04.08.09
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_EE_Russian_Red 04.08.09
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_ES_English_Red v04.08.02
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_ES_Spanish_Red v.04.08.02
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_FI_Finnish_Red 04.08.10
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_FR_French_Red V00.00
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_GR_English_Red 03.06.06
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_GR_Greek_Red 04.08.08
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_HR_Croatian_Red 04.08
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_HU_Hungarian_Red v.04.08.08
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_LT_Lithuanian_Red 04.08.04
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_LV_Latvian_Red 04.08.10
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_LV_Russian_Red 04.08.10
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_NL_Dutch_Red V04080600
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_NO_Norwegian_Red 04.08.09
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_PL_Polish_Red 08
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_PT_Portuguese_Red V09.00
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_SE_Swedish_Red 04.08.09
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_SK_Slovak_Red 04.08.09
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_CZ_Czech_For enrolled patients_Red v04.08.09
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_DE_German_NonRed 03.06.00
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_ES_Spanish_Red v03.01.00
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_FR_French_Red V04.07.06
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_HU_Hungarian_NonRed V03.06.07
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_NL_Dutch_Red V04080600
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_SE_Swedish_NonRed 1.0
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_3_ES_Spanish_NonRed v02.02.00
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_AT_German_Red v03.01.02
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_BE_Dutch_Red v03.01.01
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_BE_English_Red v03.01.01
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_BE_French_Red v03.01.01
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_BG_Bulgarian_Red 03.01.02
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_BG_English_Red 03.01
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_CZ_Czech_Red v03.02.03
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_DE_German_Red 04.08.03
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_DK_Danish_NonRed V02.02.00
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_ES_Spanish_NonRed v03.01.00
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_HR_Croatian_Red 03.01.02
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_HU_Hungarian_Red v.03.01.02
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_LV_Latvian_Red 03.01.03
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_LV_Russian_Red 03.01.03
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_NL_Dutch_Red V03010200
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_PL_Polish_Red 03.01.03
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_PT_Portuguese_Red V02.00
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_SK_Slovak_NonRed V2
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_2_BG_Bulgarian_NonRed 1.0
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_2_BG_English_NonRed 1.0
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_2_DE_German_Red 01.01.00
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_2_HR_Croatian_NonRed v02.02.01
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_2_NL_Dutch_Red V03010201
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_2_PL_Polish_NonRed 3.0
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_3_HR_Croatian_NonRed v02.02.03
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_3_HU_Hungarian_NonRed v02.02.03
Subject information and informed consent form (for publication) L1_ICF - Parent Legal Guardian_1_FR_French_NonRed V00.00
Subject information and informed consent form (for publication) L1_ICF - Pregnancy Follow up Parent Legal Guardian_1_GR_English_Red 0.1
Subject information and informed consent form (for publication) L1_ICF - Pregnancy Follow up Parent Legal Guardian_1_GR_Greek_Red 0.1
Subject information and informed consent form (for publication) L1_ICF - Separate Data Protection Consent_1_CZ_Czech_NonRed v04.08.02
Subject information and informed consent form (for publication) L1_ICF - Separate Data Protection Consent_1_FR_French_NonRed 29Jan2021
Subject information and informed consent form (for publication) L1_ICF - Separate Data Protection Consent_1_SK_Slovak_NonRed V2
Subject information and informed consent form (for publication) L1_ICF - Separate Data Protection Consent_2_SK_Slovak_NonRed V2
Subject information and informed consent form (for publication) L1_ICF Covid-Adult_1_LT_Lithuanian_Red 01.00
Subject information and informed consent form (for publication) L1_List of submitted documents Part II_1_CZ_NonRed V1
Subject information and informed consent form (for publication) L1_List of submitted documents Part II_2_HU_NonRed 07Oct2025
Subject information and informed consent form (for publication) L1_List of submitted documents_1_HU_Hungarian_NonRed 30Jan2025
Subject information and informed consent form (for publication) L1_Patient Card_1_CZ_Czech_NonRed 24Jan2024
Subject information and informed consent form (for publication) L1_Subject Info Sheet or Other Info_1_AT_German_Red v8
Subject information and informed consent form (for publication) L1_Subject Info Sheet or Other Info_1_SK_Slovak_NonRed V1
Subject information and informed consent form (for publication) L1_Subject Info Sheet or Other Info_2_SK_Slovak_NonRed 15/05/2009
Subject information and informed consent form (for publication) L1_Subject Info Sheet or Other Info_3_SK_Slovak_NonRed V2
Subject information and informed consent form (for publication) L1_Subject Info Sheet or Other Info_4_SK_Slovak_NonRed V2
Subject information and informed consent form (for publication) L1_Subject Info Sheet or Other Info_5_SK_Slovak_NonRed V2
Subject information and informed consent form (for publication) L1_Subject Info Sheet or Other Info_6_SK_Slovak_NonRed V3
Subject information and informed consent form (for publication) L1_Subject Info Sheet or Other Info_7_SK_Slovak_NonRed 01/01/2011
Subject information and informed consent form (for publication) L2_ICF Procedure_1_BE_English_Red 13Sep2024
Subject information and informed consent form (for publication) L2_ICF Procedure_1_DE_English_NonRed V01
Subject information and informed consent form (for publication) L2_ICF Procedure_1_ES_Spanish_NonRed 7/Oct/2024
Subject information and informed consent form (for publication) L2_ICF Procedure_1_GR_English_Red 1.0
Subject information and informed consent form (for publication) L2_ICF Procedure_1_NO_English_NonRed 1
Subject information and informed consent form (for publication) L2_ICF Procedure_1_PT_English_NonRed v01
Subject information and informed consent form (for publication) L2_ICF Procedure_1_SE_English_Note to Assesor_NonRed 09Feb2025
Subject information and informed consent form (for publication) L2_Patient Card_1_Hungarian_NonRed 2.0
Summary of Product Characteristics (SmPC) (for publication) E2_Reference Label_1_Boostrix_English_NonRed 12Apr2024
Summary of Product Characteristics (SmPC) (for publication) E2_Reference Label_1_flucelvax-tetra_English_NonRed 12Apr2024
Summary of Product Characteristics (SmPC) (for publication) E2_Reference Label_1_Kesimpta_English_NonRed 29Apr2024
Summary of Product Characteristics (SmPC) (for publication) E2_Reference Label_1_Pneumovax_English_NonRed 15Dec2022
Summary of Product Characteristics (SmPC) (for publication) E2_Reference Label_1_prevenar-13_English_NonRed 12Apr2024
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Bulgarian_Red V1.0
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Czech_Red v04.01
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Dutch_Red V00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_English_Red V00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_French_Red V0
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_German_Red v00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Greek_Red 00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Hungarian_Red v00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Lithuanian_Red 0
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Norwegian_Red 0
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Polish_Red 0
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Portuguese_Red V01.00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Slovak_Red V1
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Spanish_Red v00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2023-507906-15-00_1_Swedish_Red v00

Application history

12 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-13 Germany Acceptable with conditions
2024-07-19
 2024-07-19
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-12-20 Germany Acceptable with conditions
2024-07-19
 2024-12-20
3 NON SUBSTANTIAL MODIFICATION NSM-2 2025-01-08 Germany Acceptable with conditions
2024-07-19
 2025-01-08
4 SUBSTANTIAL MODIFICATION SM-1 2025-03-10 Germany Acceptable
2025-06-17
 2025-06-17
5 SUBSTANTIAL MODIFICATION SM-7 2025-07-28 Acceptable 2025-08-28
6 SUBSTANTIAL MODIFICATION SM-3 2025-07-29 Acceptable 2025-09-19
7 SUBSTANTIAL MODIFICATION SM-4 2025-08-04 Acceptable 2025-09-18
8 SUBSTANTIAL MODIFICATION SM-2 2025-08-12 Acceptable 2025-09-16
9 SUBSTANTIAL MODIFICATION SM-5 2025-08-29 Acceptable 2025-10-13
10 SUBSTANTIAL MODIFICATION SM-6 2025-10-14 Acceptable 2025-11-14
11 SUBSTANTIAL MODIFICATION SM-8 2025-12-15 Germany Acceptable
2026-03-09
 2026-03-09
12 NON SUBSTANTIAL MODIFICATION NSM-5 2026-04-07 Acceptable
2026-03-09
 2026-04-07

Related clinical trials