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 has been completed.
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: September 5, 2014
Last verified: September 2014
  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


Enrollment: 120
Study Start Date: April 2012
Study Completion Date: September 2013
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
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, see Learn About Clinical Studies.

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

Locations
France
Maison Du Département
Neufchâtel En Bray, France, 76270
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: September 5, 2014
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 October 22, 2014