Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
936
Countries
9
Sites
44
Prevention of Respiratory syncytial virus (RSV) infection in infants and children at increased risk for severe RSV disease
To evaluate the safety and tolerability of clesrovimab (MK-1654) compared to palivizumab in respiratory syncytial virus (RSV) Season 1 as assessed by the proportion of participants experiencing AEs.
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Pediatric, Patients, Healthy volunteers
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 25 Nov 2021 → 16 Oct 2025
- Decision date (initial)
- 2023-06-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2022-500752-39-00
- EudraCT number
- 2020-005996-11
- WHO UTN
- U1111-1278-0093
- ClinicalTrials.gov
- NCT04938830
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Pharmacokinetic, Pharmacodynamic, Safety, Efficacy
To evaluate the safety and tolerability of clesrovimab (MK-1654) compared to palivizumab in respiratory syncytial virus (RSV) Season 1 as assessed by the proportion of participants experiencing AEs.
Secondary objectives 5
- To estimate the efficacy of clesrovimab compared to palivizumab as assessed by the incidence of RSV-associated medically attended lower respiratory infection (MALRI) (outpatient and inpatient) from Days 1 through 150 post Dose 1 in RSV Season 1.
- To estimate the incidence of RSV-associated hospitalizations from Days 1 through 150 post Dose 1 in RSV Season 1 in the clesrovimab and palivizumab groups.
- To describe the serum PK concentration of clesrovimab at Days 7, 150, and 240 after the dose of clesrovimab in RSV Season 1.
- To describe the safety of clesrovimab administered in RSV Season 2 as assessed by the proportion of participants experiencing AEs.
- To describe the serum PK concentration of clesrovimab at Days 7 and 150 postdose in RSV Season 2.
Conditions and MedDRA coding
Prevention of Respiratory syncytial virus (RSV) infection in infants and children at increased risk for severe RSV disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10066742 | Respiratory syncytial virus infection prophylaxis | 10042613 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-002755-PIP01-19
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants at increased risk for severe respiratory syncytial virus (RSV) infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
- Is available to complete the follow-up period.
- Is male or female and has a chronological age from birth up to 1 year and is entering their first RSV season.
Exclusion criteria 6
- Requires mechanical ventilation at time of enrollment.
- Has a life expectancy <6 months.
- Has known hepatic or renal dysfunction, or chronic seizure disorder.
- Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
- Has severe immunodeficiency or is severely immunocompromised.
- Has known hypersensitivity to any component of clesrovimab or palivizumab.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 7
- Percentage of participants with solicited injection-site Adverse Events (AEs) in respiratory syncytial virus (RSV) Season 1
- Percentage of participants with solicited daily body temperature with fever in RSV Season 1
- Percentage of participants with solicited systemic AEs in RSV Season 1
- Percentage of participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1
- Percentage of participants with rash AESI in RSV Season 1
- Percentage of participants with non-serious AEs in RSV Season 1
- Percentage of participants with serious AEs (SAEs) through the duration of participation in RSV Season 1
Secondary endpoints 11
- Percentage of participants with RSV-associated medically attended lower respiratory infection (MALRI) in RSV Season 1
- Percentage of participants with RSV-associated hospitalization in RSV Season 1
- Percentage of participants with solicited injection-site AEs in RSV Season 2
- Percentage of participants with solicited daily body temperature with fever in RSV Season 2
- Percentage of participants with solicited systemic AEs in RSV Season 2
- Percentage of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2
- Percentage of participants with rash AESI in RSV Season 2
- Percentage of participants with non-serious AEs in RSV Season 2
- Percentage of participants with SAEs through 180 days postdose in RSV Season 2
- Serum concentration of clesrovimab (MK-1654) after dose of clesrovimab in RSV Season 1
- Serum concentration of clesrovimab after dose of clesrovimab in RSV Season 2
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9355634 · Product
- Active substance
- Clesrovimab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 210 mg milligram(s)
- Max total dose
- 315 mg milligram(s)
- Max treatment duration
- 60 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Synagis 100 mg/1 ml solution for injection
PRD8843559 · Product
- Active substance
- Palivizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 15 mg/Kg milligram(s)/kilogram
- Max total dose
- 75 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 120 Day(s)
- Authorisation status
- Authorised
- ATC code
- J06BB16 — PALIVIZUMAB
- Marketing authorisation
- EU/1/99/117/004
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
Isotone Natriumchloridlösung 0,9 % Braun Injektionslösung
PRD567881 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 6697366.00.00 (ENR 0697366)
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo to MK-1654 - Saline for injection
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 1 Merck Drive, P. O. Box 100 P. O. Box 100
- City
- Whitehouse Station
- Postcode
- 08889-3400
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Luis Castagnini
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Luis Castagnini
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Pharma Medica Research Inc. ORG-100011951
|
Mississauga, Canada | Laboratory analysis |
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Eurofins Viracor Biopharma Services LLC ORG-100041736
|
Lenexa, United States | Laboratory analysis |
| Matthews Media Group Inc. ORG-100045638
|
Rockville, United States | Code 2 |
Locations
9 EU/EEA countries · 44 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 24 | 3 |
| Finland | Ended | 25 | 6 |
| France | Ended | 20 | 3 |
| Germany | Ended | 67 | 4 |
| Greece | Ended | 26 | 4 |
| Hungary | Ended | 65 | 8 |
| Italy | Ended | 25 | 5 |
| Norway | Ended | 5 | 1 |
| Spain | Ended | 60 | 10 |
| Rest of world
New Zealand, Malaysia, Mexico, Turkey, Canada, Chile, Puerto Rico, Thailand, Australia, Japan, Taiwan, United Kingdom, Colombia, United States, South Africa, Singapore, Peru
|
— | 619 | — |
Investigational sites
The Institute For The Care Of Mother And Child
Pediatrické oddělení, 157, Podolske Nabrezi 1110, Prague 4
University Hospital Ostrava
Oddělení neonatologie, 17. Listopadu 1790/5, 708 00, Poruba
Fakultni Nemocnice Brno
Neonatologické oddělení, Jihlavska 340/20, Bohunice, Brno
Rokotetutkimuskeskus Finvac Oy
FVR, Seinäjoen rokotetutkimusklinikka, Kauppatori 1-3, 60100, Seinajoki
Rokotetutkimuskeskus Finvac Oy
FVR, Turun rokotetutkimusklinikka, Lemminkaisenkatu 14-18 B, 20520, Turku
Helsinki University Central Hospital
MeVac – Meilahti Vaccine Research Center, Haartmaninkatu 8, 00290, Helsinki
Rokotetutkimuskeskus Finvac Oy
FVR, Oulun Rokotetutkimusklinikka, Kiviharjunlenkki 6, 90220, Oulu
FVR Suomen rokotetutkimus Oy
FVR, Tampereen rokotetutkimusklinikka, Tullikatu 6, 33100, Tampere
Rokotetutkimuskeskus Finvac Oy
FVR, Kokkolan rokotetutkimusklinikka, Rantakatu 16, 67100, Kokkola
Centre Hospitalier Universitaire De Bordeaux
Neonatology 4th North Maternity Maternity, Pellegrin Group, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Universitaire De Caen Normandie
Medical Pediatric Department, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier De Versailles
Neonatology Department, 177 Rue De Versailles, 78150, Le Chesnay-Rocquencourt
University Of Leipzig
Department of Pediatrics, Liebigstrasse 20a, Zentrum-Suedost, Leipzig
Medizinische Hochschule Hannover Service GmbH
Clinic for pediatric pneumology, allergology and neonatology, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Technische Universitat Dresden
Department neonatology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Medical Center - University Of Freiburg
University heart center Clinic für congenital heart diseases and pediatric cardiology, Breisacher Strasse 62, Stuehlinger, Freiburg Im Breisgau
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
2nd Department of Pediatrics, University of Athens, Thivon And Leivadias, Ampelokipoi, Athens
Nosokomeio Paidon I Agia Sofia
1st Pediatric Clinic, University of Athens, Thivon, Papadiamantopoulou, Athens
Hippokration Hospital
Infectious diseases Unit & Research Laboratory, Konstadinoupoleos 49, 546 42, Thessaloniki
University General Hospital Attikon
3rd Pediatric Clinic, University of Athens, Rimini Street 1, 124 62, Athens
University Of Debrecen
Gyermekgyógyászati Intézet, Nagyerdei Korut 98, 4032, Debrecen
Gottsegen National Cardiovascular Center
Gyermekszív Központ, Kerulet, Haller Utca 29/IX., Budapest
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Gyermekgyógyászati Osztály, Szent Istvan Utca 68, 4400, Nyiregyhaza
Bacs-Kiskun Varmegyei Oktatokorhaz
Gyermekosztály, Nyiri Ut 38, 6000, Kecskemet
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Újszülött Intenzív Osztály, Szentpeteri Kapu 72-76, 3526, Miskolc
Bajai Szent Rokus Korhaz
Gyermekosztály, Rokus Utca 10, 6500, Baja
Peterfy Sandor Utcai Korhaz-Rendelointezet
Neonatológia- és Csecsemőosztály PIC 2, Peterfy Sandor Utca 8-20/ VII, Kerulet, Budapest
Semmelweis University
Szülészeti és Nőgyógyászati Klinika, Ulloi Ut 78, 1082, Budapest
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
U.O di Neonatologia e Terapia Intensiva Neonatale, Via Della Commenda 12, 20122, Milan
Azienda Ospedaliera Di Padova
UOC Terapia Intensiva e Patologia Neonatale, Assistenza Neonatale, Via Nicolo Giustiniani 2, 35128, Padova
Azienda Ospedaliero Universitaria Parma
UO Clinica Pediatrica, Viale Antonio Gramsci 14, 43126, Parma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.S di Malattie Infettive Pediatriche, Largo Francesco Vito 1, 00168, Rome
Bambino Gesu Childrens Hospital
Broncopneumologia, Piazza Sant'onofrio 4, 00165, Rome
Oslo University Hospital HF
The Children's and Youth Clinic, Taarnbygget, Kirkeveien 166, Oslo
Hospital Universitario Quironsalud Madrid
Department of Pediatrics, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Central De Asturias
Neonatology, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario 12 De Octubre
Department of Pediatrics, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitari Germans Trias I Pujol
Department of Pediatrics, Carretera Canyet 1a Planta, 08916, Badalona
Grupo Pediátrico UNCIBAY
Department of Pediatrics, Calle de Molina Lario 7 Planta2, 29015, Malaga
Hospital Universitario Hm Monteprincipe
Department of Pediatrics, Avenida De Monteprincipe 25, 28668, Boadilla Del Monte
Hospital Universitari General De Catalunya
Department of Pediatrics, Calle Pedro I Pons 1, 08195, Barcelona
Hospital Sant Joan De Deu Barcelona
Department of Pediatrics, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Hospital Universitario La Paz
Neonatology, Paseo Castellana 261, 28046, Madrid
Complexo Hospitalario Universitario De Santiago
Department of Pediatrics, Calle Choupana Da S/n, 15706, Santiago De Compostela
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2022-10-26 | 2025-04-22 | 2022-10-31 | 2024-01-26 | |
| Finland | 2021-12-08 | 2024-12-09 | 2021-12-10 | 2024-03-15 | |
| France | 2021-12-02 | 2024-04-10 | 2021-12-08 | 2023-01-24 | |
| Germany | 2021-12-13 | 2024-12-20 | 2021-12-30 | 2023-12-19 | |
| Greece | 2022-03-29 | 2025-06-02 | 2022-09-15 | 2024-02-20 | |
| Hungary | 2021-11-26 | 2024-11-20 | 2021-12-02 | 2024-01-26 | |
| Italy | 2022-08-31 | 2025-05-12 | 2022-11-11 | 2024-03-02 | |
| Norway | 2021-12-23 | 2025-04-28 | 2022-01-07 | 2024-05-08 | |
| Spain | 2021-11-25 | 2024-04-15 | 2021-11-30 | 2023-01-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| MK-1654-007 Summary of Results SUM-127736
|
2026-04-07T14:58:57 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Results Plain Language Summaries | 2026-04-07T14:59:45 | Submitted | Laypersons Summary of Results |
Documents 92 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | m5351-p007pv01mk1654-p-app1619-sap | 01 |
| Clinical study report (for publication) | m5351-p007v01mk1654-p-app1611-protocol | 01 |
| Clinical study report (for publication) | m5351-p007v01mk1654-p-app1612-crf | 1 |
| Clinical study report (for publication) | m5351-p007v01mk1654-p-csr-body | 01 |
| Laypersons summary of results (for publication) | RPLS_CZE_CZ_for pub | 09MAR2026 |
| Laypersons summary of results (for publication) | RPLS_DEU_DE_for pub | 09MAR2026 |
| Laypersons summary of results (for publication) | RPLS_EN_for pub | 09MAR2026 |
| Laypersons summary of results (for publication) | RPLS_ESP_ES_for pub | 09MAR2026 |
| Laypersons summary of results (for publication) | RPLS_FIN_FI_for pub | 09MAR2026 |
| Laypersons summary of results (for publication) | RPLS_FRA_FR_for pub | 09MAR2026 |
| Laypersons summary of results (for publication) | RPLS_GRC_EL_for pub | 09MAR2026 |
| Laypersons summary of results (for publication) | RPLS_HUN_HU_for pub | 09MAR2026 |
| Laypersons summary of results (for publication) | RPLS_ITA_IT_for pub | 09MAR2026 |
| Laypersons summary of results (for publication) | RPLS_NOR_NN_for pub | 09MAR2026 |
| Protocol (for publication) | D1_Protocol_2022-500752-39_GRC_EL_SM06_for pub | 03R |
| Protocol (for publication) | D1_Protocol_2022-500752-39-00_SM06_for pub | 3R |
| Protocol (for publication) | D4_Subject questionnaire_DEU_DE_for pub | 1.0 |
| Protocol (for publication) | D4_Subject questionnaire_for pub | 13SEP2021 |
| Protocol (for publication) | D4_Subject questionnaire_FRA_FR_for pub | 1 |
| Protocol (for publication) | D4_Subject questionnaire_FRA_FR_for pub | 4.0 |
| Protocol (for publication) | D4_Subject questionnaire_HUN_HU_for pub | 1.0 |
| Protocol (for publication) | D4_Subject questionnaire_ITA_IT_for pub | 01 |
| Protocol (for publication) | D4_Subject Questionnaire_NOR_eCOA Screen Report_NN_for pub | 1.0 |
| Protocol (for publication) | D4_Subject Questionnaire_NOR_Study Participant User Guide_NN_for pub | 1.0 |
| Protocol (for publication) | D4_Subject questionnaire_Screen Report_GRC_EL_for pub | 2.0 |
| Protocol (for publication) | D4_Subject questionnaire_User Guide_ITA_IT_for pub | v2 |
| Protocol (for publication) | D4_User guide_DEU_DE_for pub | 2.0 |
| Protocol (for publication) | D4_User Guide_HUN_HU_for pub | 1.0 |
| Protocol (for publication) | D4_User guidefor for pub | 2.0 |
| Protocol (for publication) | Subject Questionnaire_CZE_Device Label_Czech_for publication | 1 |
| Protocol (for publication) | Subject Questionnaire_CZE_eCOA Screen Report_Czech_for publication | 2 |
| Protocol (for publication) | Subject Questionnaire_CZE_Study Participant User Guide_Czech_for publication | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FIN_for pub | 20JUL2021 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_for pub | v1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Letter of Invitation_CZE_CS_not pub | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements AESI Card_CZE_Czech_for publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements Appoitment Reminder Card_CZE_Czech_for publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements Brochure_CZE_Czech_for publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements CRIS Card_CZE_Czech_for publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements High-risk Brochure_CZE_Czech_for publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements High-risk Poster_CZE_Czech_for publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements Patient Visit Guide_CZE_Czech_for publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements Physician Referral Flyer_CZE_Czech_for publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements Poster_CZE_Czech_for publication | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_CZE_CS_SM06_for pub | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc hrisk Poster_ITA_IT_for pub | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_DEU_DE_for pub | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_ITA_IT_for pub | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Flyer_CZE_CS_SM06_for pub | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient hrisk Brochure_ITA_IT_for pub | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Physician Referral Flyer_DEU_DE_for pub | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_DEU_DE_for pub | 01Dec2021 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_ITA_IT_for pub | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_DEU_EN_for pub | 0.1 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_FIN_EN_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_FIN_FI_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_FIN_SV_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_ITA_IT_for pub | v01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR data privacy_ITA_IT_for pub | 02AUG2023 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR parent consent_DEU_DE_for pub | 1.0R |
| Subject information and informed consent form (for publication) | L1_ICF_FBR parent_CZE_Czech_for publication | 14SEP2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_EN_for pub | AM01v1.02 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FIN_EN_for pub | AM01v1.02 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FIN_FI_for pub | 1.04R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FIN_SV_for pub_ | AM01v1.02 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM06_for pub | AM01v1.04 |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_SM06_for pub | 15OCT2024 |
| Subject information and informed consent form (for publication) | L1_ICF_Main GDPR_CZE_czech_for publication | 01MAY2022 |
| Subject information and informed consent form (for publication) | L1_ICF_Main parent consent_DEU_DE_for pub | 1.4R |
| Subject information and informed consent form (for publication) | L1_ICF_Main parent CZE_CS_for pub | Czech v5R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_add reimbursement_DEU_DE_for pub | 18AUG2023R |
| Subject information and informed consent form (for publication) | L1_Patient ID Card_CZE_CS_for pub | 1.0.1.2R |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Q and RSI_Palivizumab_for pub | 18APR2023 |
| Summary of results (for publication) | Summary of Results_2022-500752-39_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_CZE_CS_2022-500752-39_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_DEU_DE_2022-500752-39_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_EN_2022-500752-39-00_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_ESP_ES_2022-500752-39-00_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_FRA_FR_2022-500752-39_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_GRC_EL_2022-500752-39-00_for pub | 31Jul2023 |
| Synopsis of the protocol (for publication) | D1_PPLS_HUN_HU_2022-500752-39_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_ITA_IT_2022-500752-39_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_NOR_NN_2022-500752-39_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_CZE_Czech_for publication | 06JUN2022 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_DEU_DE_for pub | 00 |
| Synopsis of the protocol (for publication) | D1_Protocol scientific synopsis_ESP_Spanish_for publication | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_GRC_EL_2022-500752-39-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_GRC_EL_for pub | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_HUN_HU_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_ITA_IT_for pub | 02 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis layman language_FRA_French_for publication | 3.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-31 | Finland | Acceptable 2023-05-17
|
2023-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-11 | Finland | Acceptable 2023-11-13
|
2023-11-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-23 | Acceptable | 2024-02-19 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-12 | Acceptable | 2024-05-08 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-08 | Finland | 2024-05-08 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-04 | Finland | 2024-07-04 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-09-20 | 2024-09-20 | ||
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-22 | Finland | Acceptable 2025-02-10
|
2025-02-11 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-03-14 | Acceptable 2025-05-30
|
2025-05-30 |