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

NCT ID: NCT01565577

Last Updated: 2014-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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Conditions

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Vaccination With MenbVac

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Bras A

Group Type EXPERIMENTAL

MenbVac

Intervention Type BIOLOGICAL

Blood test

Interventions

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MenbVac

Blood test

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Direction Générale de la Santé, France

OTHER

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role collaborator

Dieppe

UNKNOWN

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Caron, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU - Hôpitaux de Rouen

Locations

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UH-rouen

Rouen, Seine Maritime, France

Site Status

Countries

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France

Other Identifiers

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2011/199/HP

Identifier Type: -

Identifier Source: org_study_id

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