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Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 in Patients Having to be Vaccinated MenBVac® (Extension EFFIVAC) (Exten Effivac)

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ClinicalTrials.gov Identifier: NCT01621945
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : September 8, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.

Condition or disease Intervention/treatment Phase
Neisseria Meningitidis Biological: MenBvac Phase 3

Study Design

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Neisseria Meningitidis B:14,P1.7,16 Strain in Child
Study Start Date : April 2012
Primary Completion Date : April 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

Group/Cohort Intervention/treatment
Bras A
children, born between the 06/04/2004 and the 17/04/2008, living around Neufchatel en Bray, before the fourth dose of MenBVac
Biological: MenBvac
Blood test

Outcome Measures

Primary Outcome Measures :
  1. Vaccine Immunity [ Time Frame: after the fourth dose of MenbVac ]
    Assessment of vaccine Immunity with measure of percentage of children who have hSBA title >= 4 six weeks after the fourth dose of vaccine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children aged 4 to 8 years old and living in neufchatel en bray area

Inclusion Criteria:

  • children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray,and Having participated to the first study,
  • children who Have to be Vaccinated MenBVac® for the four times,
  • parental authority(ies)assent.

Exclusion Criteria:

  • no parental authority(ies)assent,
  • no blood sample,
  • impossibility of fourth vaccination,
  • children yet vaccinated or non eligible for 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): NCT01621945

Maison Du Département
Neufchâtel En Bray, France, 76270
Sponsors and Collaborators
University Hospital, Rouen
Direction Générale de la Santé, France
Institut Pasteur
More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01621945     History of Changes
Other Study ID Numbers: 2011/198/HP
First Posted: June 18, 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
OMV vaccine