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NCT01054053 Clinical Trial

Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Have to be Vaccinated MenBVac®

Vaccination Clinical Trial

— EFFIVAC  

Official title:
Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01054053
Other study ID # 2009/042/HP
Secondary ID 2009-011401-16
Status Completed
Phase N/A
First received November 26, 2009
Last updated March 22, 2012
Start date April 2009
Est. completion date January 2011

Study information
Verified date March 2012
Source University Hospital, Rouen
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

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 first vaccination (T0), after the second MenBvac vaccination (6 weeks after the second vaccination), before the third MenBvac vaccination and after the third MenBvac vaccination (6 weeks after the second vaccination) and one year after the third menBvac vaccination.

Recruitment information / eligibility
Status Completed
Enrollment 218
Est. completion date January 2011
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 5 Years
Eligibility Inclusion Criteria:

- children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray, vaccinated five times by MenBVac

- parental authority(ies)assent

Exclusion Criteria:

- no parental authority(ies)assent

- no blood sample during the third vaccination

- impossibility of third vaccination

- children with guardianship

- children yet vaccinated or non eligible for vaccination

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Maison Du Département Neufchâtel En Bray

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Rouen Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary assessment of natural Immunity with measure of percent of children who have hSBA title >= 4 at TO. assessment of antibodies blood persistence during measurement of percent of children who have hSBA title >= 4 18 months No
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