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

March 22, 2012 updated by: University Hospital, Rouen

Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Neufchâtel En Bray, France, 76270
        • Maison Du Département

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
children born between 06/04/2004 and 17/04/2008 and called to menBvac vaccination and living around Neufchatel en Bray.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Collaborators

Institut Pasteur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

November 26, 2009

First Submitted That Met QC Criteria

January 21, 2010

First Posted (Estimate)

January 22, 2010

Study Record Updates

Last Update Posted (Estimate)

March 23, 2012

Last Update Submitted That Met QC Criteria

March 22, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009/042/HP
  • 2009-011401-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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