Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
84
Countries
1
Sites
20
Asplenia
The primary objective of this trial is to assess immunogenicity one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms), in asplenic adults.
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 15 Sep 2022 → ongoing
- Decision date (initial)
- 2024-08-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513649-35-00
- EudraCT number
- 2019-000924-17
- ClinicalTrials.gov
- NCT04166656
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Efficacy
The primary objective of this trial is to assess immunogenicity one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms), in asplenic adults.
Secondary objectives 5
- To evaluate for each vaccine strategy, the immunogenicity one month after the completeness of the vaccination scheme (M2/M7) (GMT, proportion of responders to the threshold of 8) in asplenic adults.
- To assess persistence and evolution of immune response until 48 months post 1st immunization for each vaccine strategy in asplenic adults (at M12, M24, and M36 and M48).
- To assess determinants of immune response to each vaccine strategy in asplenic adults.
- To evaluate, for each vaccine strategy, clinical and biological safety of the vaccines in asplenic adults.
- To assess safety and effectiveness of Bexsero® and Trumenba® in asplenic adults older than 65 years of age.
Conditions and MedDRA coding
Asplenia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10053622 | Asplenia | 100000004850 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Male or female, >=18 to <=75 years old
- Asplenic patient (for at least 2 weeks) with Howell Jolly bodies visible on blood film
- Splenectomy confirmed by consultation and/or hospitalization report or the ultrasound if it has been performed during the routine follow-up
- Women of childbearing age must have an effective contraception during the first 9 months of the study.
- Participants must give written consent prior to any trial procedure.
- Participants must be covered by social security regimen or equivalent.
- Participants will be followed during the 4 years from the inclusion visit.
Exclusion criteria 13
- History of meningococcal B vaccination.
- History of anaphylaxis post vaccination.
- Known allergy to any components (active substances or excipients) of both vaccines.
- Patients who cannot stop antibiotics 3 days before blood collection.
- Participants who have received any another vaccines within 4 weeks prior to immunization or who are planning to receive any vaccine within the first 7 months of the study (excepted meningocoque ACWY vaccine, pneumococcal vaccine, Haemophilus vaccine, Covid-19 vaccine and annual influenza vaccination which is permitted 2 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up).
- Parenteral Ig within the 3 months prior to VS or planned during the study.
- Chemotherapy agents within 6 months prior M0 or planning to take any during the study.
- Steroids (> 10mg/day; > 14 days) within the month preceding M0 or planning to take any during the study.
- Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo / autograft, primary immunodeficiency, nephrotic syndrome, evolutive cancer, cirrhosis, known infection to HIV;
- Thrombocytopenia or any coagulation disorder contra-indicating intramuscularly injections.
- Pregnancy, breastfeeding or positive pregnancy test up to 7 months after inclusion.
- Severe acute febrile illness within the week before inclusion
- Registration for any other clinical trial throughout the trial period except observational study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of responders defined as participants with seroconversion (i.e. hSBA titer increases from <4 before vaccination to at least 4) or with hSBA titer showing a 4-fold increase (if hSBA titer was at least 4 before vaccination) one month after the completeness of three anti-meningococci B vaccine strategies (at M7 for all arms) in asplenic adults.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD5038632 · Product
- Active substance
- Neisseria Meningitidis Group B Fhbp Protein Subfamily A
- Substance synonyms
- NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LIPOPROTEIN (RLP2086, SUBFAMILY A)
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 1 U unit(s)
- Max total dose
- 3 U unit(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/17/1187/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD2149122 · Product
- Active substance
- Recombinant Neisseria Meningitidis Group B Nhba Fusion Protein Produced in E. Coli Cells by Recombinant DNA Technology Adsorbed on Aluminium Hydroxide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 1 U unit(s)
- Max total dose
- 3 U unit(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07AH09 — -
- Marketing authorisation
- EU/1/12/812/001
- MA holder
- GSK VACCINES S.R.L.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Odile LAUNAY
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Odile LAUNAY
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Odile LAUNAY
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Odile LAUNAY
Locations
1 EU/EEA country · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 84 | 20 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
CIC Vaccinologie Cochin-Pasteur CIC 1417, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Assistance Publique Hopitaux De Paris
Centre d'Investigation Clinique, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Assistance Publique Hopitaux De Paris
Médecine Interne, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Annecy Genevois
Maladies Infectieuses, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
University Hospital Of Clermont-Ferrand
Maladies infectieuses et tropicales – Vaccinations, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Centre Hospitalier Universitaire De Dijon
CIC 1432 Module Plurithématique et Service de Gastro-entérologie et Hépatologie, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Lille
CIC Hôpital cardiologique, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Hospices Civils De Lyon
CRC et Service des maladies infectieuses Maladies Infectieuses et Tropicales, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Hospitalier Universitaire De Montpellier
Maladies Infectieuses et Tropicales, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nantes
Maladies Infectieuses et Tropicales, Centre de Prévention des Maladies Infectieuses & Transmissibles, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Rennes
Unité d'Investigation Clinique CIC 1414- Pôle Santé Publique, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Saint Etienne
Maladies infectieuses et tropicales - CIC-CIE3, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Les Hopitaux Universitaires De Strasbourg
Centre d'Investigation Clinique INSERM CIC-1434, 1 Place De L Hopital, 67000, Strasbourg
Centre Hospitalier Universitaire Grenoble Alpes
Centre d'investigation clinique CIC1406, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Departemental Vendee
Médecine post-urgence – maladies infectieuses, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Universitaire Rouen
Centre d'Investigation Clinique CIC-CRB 1404, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Caen Normandie
Maladies Infectieuses et Tropicales, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire D'Angers
Maladies Infectieuses et Tropicales, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Regional De Marseille
Centre d'Investigation Clinique CIC 1409, Centre de néphrologie et de transplantation rénale, 147 Boulevard Baille, 13005, Marseille
Centre Hospitalier Regional Et Universitaire De Brest
Centre d'Investigation Clinique CIC-P 1412, Service des Maladies Infectieuses et Tropicales, Boulevard Tanguy Prigent, 29200, Brest
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 |
|---|---|---|---|---|---|
| France | 2022-09-15 | 2022-09-15 | 2024-07-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_List investigators_2024-513649-35-00_P | 4 |
| Protocol (for publication) | D1_Protocol_2024-513649-35-00_P | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF majeur | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC BEXSERO_initial | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC BEXSERO_update | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_TRUMENBA_initial | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_TRUMENBA_update | 1 |
| Synopsis of the protocol (for publication) | D1_Synopsis-ENG_2024-513649-35-00_P | 4 |
| Synopsis of the protocol (for publication) | D1_Synopsis-FR_2024-513649-35-00_P | 4 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | France | Acceptable 2024-08-09
|
2024-08-09 |