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NCT00450554 Clinical Trial

Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac

Vaccination Clinical Trial

Official title:
EVALUATION DE LA REPONSE IMMUNITAIRE CONTRE LA SOUCHE DE NEISSERIA MENINGITIDIS B:14,P1.7,16

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00450554
Other study ID # 2007/004/HP
Secondary ID
Status Completed
Phase Phase 3
First received March 19, 2007
Last updated March 26, 2012
Start date February 2007
Est. completion date May 2008

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 01/01/2002 and the 06/23/200, living around Dieppe (cantons Dieppe est, Dieppe Ouest and Offranville), vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before and after the third MenBvac vaccination.

Recruitment information / eligibility
Status Completed
Enrollment 236
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 7 Years
Eligibility Inclusion Criteria:

- children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated twice by MenBVac

- parental authority(ies)assent

Exclusion Criteria:

- no parental authority(ies)assent

- no blood sample during the third vaccination

- impossibility of third vaccination

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France UH-rouen Rouen Seine Maritime

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

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