Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 in Patients Having to be Vaccinated MenBVac® (Extension EFFIVAC) (Exten Effivac)
June 9, 2026 updated by: University Hospital, Rouen
Phase 3, Vaccinal Activity Assessment of MenBVac Against Neisseria Meningitidis B:14,P1.7,16 Strain in Child
The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.
Study Overview
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Neufchâtel-en-Bray, France, 76270
- Maison Du Département
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Study Population
Children aged 4 to 8 years old and living in neufchatel en bray area
Description
Inclusion Criteria:
- children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray,and Having participated to the first study,
- children who Have to be Vaccinated MenBVac® for the four times,
- parental authority(ies)assent.
Exclusion Criteria:
- no parental authority(ies)assent,
- no blood sample,
- impossibility of fourth vaccination,
- children yet vaccinated or non eligible for vaccination.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bras A
children, born between the 06/04/2004 and the 17/04/2008, living around Neufchatel en Bray, before the fourth dose of MenBVac
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Blood tests and vaccine :
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Vaccine Immunity
Time Frame: after the fourth dose of MenbVac
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Assessment of vaccine Immunity with measure of percentage of children who have hSBA title >= 4 six weeks after the fourth dose of vaccine
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after the fourth dose of MenbVac
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
March 26, 2012
First Submitted That Met QC Criteria
June 15, 2012
First Posted (Estimated)
June 18, 2012
Study Record Updates
Last Update Posted (Actual)
June 12, 2026
Last Update Submitted That Met QC Criteria
June 9, 2026
Last Verified
September 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 2011/198/HP
- 2011-006209-83 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.