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Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac

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ClinicalTrials.gov Identifier: NCT00450554
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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Brief 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.

Condition or disease
Vaccination

Study Design
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Study Type : Observational
Actual Enrollment : 236 participants
Time Perspective: Prospective
Official Title: EVALUATION DE LA REPONSE IMMUNITAIRE CONTRE LA SOUCHE DE NEISSERIA MENINGITIDIS B:14,P1.7,16
Study Start Date : February 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Neisseria
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00450554     History of Changes
Other Study ID Numbers: 2007/004/HP
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2012

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