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

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Rouen
Sponsor:
Collaborators:
Direction Générale de la Santé, France
Institut Pasteur
Dieppe
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01565577
First received: March 26, 2012
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Vaccination With MenbVac
Biological: MenbVac
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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®

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • vaccine Immunity [ Time Frame: two and a half years after the fouth vaccination ] [ Designated as safety issue: No ]
    assessment of vaccine Immunity with measure of percentage of children with an hSBA title >= 4 four years after four doses of MenbVac


Estimated Enrollment: 235
Study Start Date: April 2012
Estimated Study Completion Date: September 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bras A Biological: MenbVac
Blood test

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565577

Contacts
Contact: François CARON, Professor 2 32 88 87 39 ext +33 francois.caron@chu-rouen.fr

Locations
France
UH-rouen Recruiting
Rouen,, Seine Maritime, France, 76000
Contact: Valérie Delbos, Doctor       valerie.delbos@chu-rouen.fr   
Sub-Investigator: Muhamed-Kheir TAHA, Doctor         
Sub-Investigator: Emmanuel JEANNOT, Doctor         
Sub-Investigator: Gilles Berthelot, Doctor         
Principal Investigator: Ludovic Lemee         
Principal Investigator: Eric MALLET, Professor         
Principal Investigator: Jean-Philippe LEROY, Doctor         
Sponsors and Collaborators
University Hospital, Rouen
Direction Générale de la Santé, France
Institut Pasteur
Dieppe
Investigators
Principal Investigator: François Caron, Professor CHU - Hôpitaux de Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01565577     History of Changes
Other Study ID Numbers: 2011/199/HP
Study First Received: March 26, 2012
Last Updated: June 22, 2012
Health Authority: France : Agence française de sécurité sanitaire des produits de santé

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

ClinicalTrials.gov processed this record on April 17, 2014