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

NCT ID: NCT01054053

Last Updated: 2012-03-23

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

Total Enrollment

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vaccination

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Pasteur

INDUSTRY

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maison Du Département

Neufchâtel-en-Bray, , France

Site Status

Countries

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France

Other Identifiers

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2009-011401-16

Identifier Type: -

Identifier Source: secondary_id

2009/042/HP

Identifier Type: -

Identifier Source: org_study_id

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