Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT00450554

First received: March 19, 2007

Last updated: March 26, 2012

Last verified: March 2012

History of Changes

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 3


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

Resource links provided by NLM:

Drug Information available for: Neisseria

U.S. FDA Resources

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 (Child)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


France
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


Responsible Party:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00450554 History of Changes
Other Study ID Numbers:	2007/004/HP
Study First Received:	March 19, 2007
Last Updated:	March 26, 2012

Keywords provided by University Hospital, Rouen:


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

ClinicalTrials.gov processed this record on September 21, 2017

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