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

This study has been completed.
Sponsor:
Collaborator:
Institut Pasteur
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01054053
First received: November 26, 2009
Last updated: March 22, 2012
Last verified: March 2012
History of Changes
  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 first vaccination (T0), after the second MenBvac vaccination (6 weeks after the second vaccination), before the third MenBvac vaccination and after the third MenBvac vaccination (6 weeks after the second vaccination) and one year after the third menBvac vaccination.


Condition
Vaccination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child.

Resource links provided by NLM:

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

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • assessment of natural Immunity with measure of percent of children who have hSBA title >= 4 at TO. assessment of antibodies blood persistence during measurement of percent of children who have hSBA title >= 4 [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood samples


Enrollment: 218
Study Start Date: April 2009
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
children born between 06/04/2004 and 17/04/2008 and called to menBvac vaccination and living around Neufchatel en Bray.

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

children born between 06/04/2004 and 17/04/2008, living Neufchatel en bray.

Criteria

Inclusion Criteria:

  • children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray, vaccinated five times by MenBVac
  • parental authority(ies)assent

Exclusion Criteria:

  • no parental authority(ies)assent
  • no blood sample during the third vaccination
  • impossibility of third vaccination
  • children with guardianship
  • children yet vaccinated or non eligible for vaccination
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054053

Locations
France
Maison Du Département
Neufchâtel En Bray, France, 76270
Sponsors and Collaborators
University Hospital, Rouen
Institut Pasteur
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01054053     History of Changes
Other Study ID Numbers: 2009/042/HP, 2009-011401-16
Study First Received: November 26, 2009
Last Updated: March 22, 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
Menbvac

ClinicalTrials.gov processed this record on June 17, 2013