Immunogenicity After Two Doses of Meningococcal Outer Membrane Vesicle Vaccine MenBVac

NCT ID: NCT00450554

Last Updated: 2012-03-27

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

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-05-31

Brief Summary

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The main objective of the study is to estimate the proportion of children, born between the 01/01/2002 and the 06/23/200, living around Dieppe (cantons Dieppe est, Dieppe Ouest and Offranville), vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (\>= 4), before and after the third MenBvac vaccination.

Detailed Description

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Conditions

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Vaccination

Study Design

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Study Time Perspective

PROSPECTIVE

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 twice by MenBVac
* parental authority(ies)assent

Exclusion Criteria

* no parental authority(ies)assent
* no blood sample during the third vaccination
* impossibility of third vaccination
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CARON François, Professor

Role: PRINCIPAL_INVESTIGATOR

Service des Maladies Intectieuses et Tropicales

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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2007/004/HP

Identifier Type: -

Identifier Source: org_study_id

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