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Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Vaccinated With MenBVac® (Extension MenbVac) (Exten MenbVac)

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ClinicalTrials.gov Identifier: NCT01565577
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : September 8, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.

Condition or disease Intervention/treatment Phase
Vaccination With MenbVac Biological: MenbVac Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac®
Study Start Date : April 2012
Primary Completion Date : June 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Bras A Biological: MenbVac
Blood test

Outcome Measures

Primary Outcome Measures :
  1. vaccine Immunity [ Time Frame: two and a half years after the fouth vaccination ]
    assessment of vaccine Immunity with measure of percentage of children with an hSBA title >= 4 four years after four doses of MenbVac

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated with four doses of MenBVac in the first MenbVac clinical trial study,
  • parental authority(ies)assent.

Exclusion Criteria:

  • no parental authority(ies)assent,
  • no parental authority(ies)assent,
  • no blood sample during the third vaccination,
  • impossibility of third vaccination.
Contacts and Locations

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): NCT01565577

Rouen,, Seine Maritime, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
Direction Générale de la Santé, France
Institut Pasteur
Principal Investigator: François Caron, Professor CHU - Hôpitaux de Rouen
More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01565577     History of Changes
Other Study ID Numbers: 2011/199/HP
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014

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