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)

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Rouen
Sponsor:
Collaborators:
Direction Générale de la Santé, France
Institut Pasteur
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01621945
First received: March 26, 2012
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Neisseria Meningitidis
Biological: MenBvac
Phase 3

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Vaccine Immunity [ Time Frame: after the fourth dose of MenbVac ] [ Designated as safety issue: No ]
    Assessment of vaccine Immunity with measure of percentage of children who have hSBA title >= 4 six weeks after the fourth dose of vaccine


Estimated Enrollment: 218
Study Start Date: April 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children aged 4 to 8 years old and living in neufchatel en bray area

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621945

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

Locations
France
Maison Du Département Recruiting
Neufchâtel En Bray, France, 76270
Contact: François CARON, Professor    2 32 88 87 39 ext +33    Francois.Caron@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Rouen
Direction Générale de la Santé, France
Institut Pasteur
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01621945     History of Changes
Other Study ID Numbers: 2011/198/HP
Study First Received: March 26, 2012
Last Updated: June 15, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on April 17, 2014