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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01565577
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : September 8, 2014
Direction Générale de la Santé, France
Institut Pasteur
Information provided by (Responsible Party):
University Hospital, Rouen

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: N/A
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
Actual Primary Completion Date : June 2012
Actual Study Completion Date : September 2012

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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.

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 identifier (NCT number): NCT01565577

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Rouen,, Seine Maritime, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
Direction Générale de la Santé, France
Institut Pasteur
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Principal Investigator: François Caron, Professor CHU - Hôpitaux de Rouen
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Responsible Party: University Hospital, Rouen Identifier: NCT01565577    
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