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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
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
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: 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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Neisseria meningitidis B:14, P1-7, 16
Serum bactericidal activity
Menbvac

ClinicalTrials.gov processed this record on May 16, 2013