Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac

This study has been completed.

First Received: March 19, 2007 Last Updated: April 6, 2009 History of Changes

Sponsored by:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00450554

Purpose

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.

Condition	Phase
Vaccination	Phase III

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	EVALUATION DE LA REPONSE IMMUNITAIRE CONTRE LA SOUCHE DE NEISSERIA MENINGITIDIS B:14,P1.7,16

Further study details as provided by University Hospital, Rouen:

Enrollment:	236
Study Start Date:	February 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	2 Years to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450554

Locations

France, Seine Maritime
UH-rouen
Rouen, Seine Maritime, France, 76000

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

CARON François, Professor

Service des Maladies Intectieuses et Tropicales

More Information

No publications provided

Responsible Party:	Rouen University Hospital ( PAIRE Christian / managing Director )
Study ID Numbers:	2007/004/HP
Study First Received:	March 19, 2007
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00450554 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:

Neisseria meningitidis B:14, P1-7, 16
Serum bactericidal activity
Menbvac

Study placed in the following topic categories:

Neisseria Meningitidis

ClinicalTrials.gov processed this record on May 07, 2009