Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Vaccinated With MenBVac® (Extension MenbVac) (Exten MenbVac)
This study is currently recruiting participants.
Verified June 2012 by University Hospital, Rouen
Sponsor:
University Hospital, Rouen
Collaborators:
Direction Générale de la Santé, France
Institut Pasteur
Dieppe
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01565577
First received: March 26, 2012
Last updated: June 22, 2012
Last verified: June 2012
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Purpose
This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Vaccination With MenbVac |
Biological: MenbVac |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac® |
Resource links provided by NLM:
Further study details as provided by University Hospital, Rouen:
Primary Outcome Measures:
- vaccine Immunity [ Time Frame: two and a half years after the fouth vaccination ] [ Designated as safety issue: No ]assessment of vaccine Immunity with measure of percentage of children with an hSBA title >= 4 four years after four doses of MenbVac
| Estimated Enrollment: | 235 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | September 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bras A |
Biological: MenbVac
Blood test
|
Eligibility| Ages Eligible for Study: | 7 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated with four doses of MenBVac in the first MenbVac clinical trial study,
- parental authority(ies)assent.
Exclusion Criteria:
- no parental authority(ies)assent,
- no parental authority(ies)assent,
- no blood sample during the third vaccination,
- impossibility of third vaccination.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565577
Contacts
| Contact: François CARON, Professor | 2 32 88 87 39 ext +33 | francois.caron@chu-rouen.fr |
Locations
| France | |
| UH-rouen | Recruiting |
| Rouen,, Seine Maritime, France, 76000 | |
| Contact: Valérie Delbos, Doctor valerie.delbos@chu-rouen.fr | |
| Sub-Investigator: Muhamed-Kheir TAHA, Doctor | |
| Sub-Investigator: Emmanuel JEANNOT, Doctor | |
| Sub-Investigator: Gilles Berthelot, Doctor | |
| Principal Investigator: Ludovic Lemee | |
| Principal Investigator: Eric MALLET, Professor | |
| Principal Investigator: Jean-Philippe LEROY, Doctor | |
Sponsors and Collaborators
University Hospital, Rouen
Direction Générale de la Santé, France
Institut Pasteur
Dieppe
Investigators
| Principal Investigator: | François Caron, Professor | CHU - Hôpitaux de Rouen |
More Information
No publications provided
| Responsible Party: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT01565577 History of Changes |
| Other Study ID Numbers: | 2011/199/HP |
| Study First Received: | March 26, 2012 |
| Last Updated: | June 22, 2012 |
| Health Authority: | France : Agence française de sécurité sanitaire des produits de santé |
Keywords provided by University Hospital, Rouen:
|
Neisseria meningitidis B:14, P1-7, 16 Serum bactericidal activity Menbvac |
ClinicalTrials.gov processed this record on May 19, 2013