Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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)
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
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
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 September 29, 2016