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

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.

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Key information

Conditions

Neisseria Meningitidis

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Maison Du Département

Neufchâtel-en-Bray, 76270, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MenBvac

Biological

Blood tests and vaccine :

First blood sample immediatly before the fourth dose of the vaccine
Fourth dose of MenBVac
Second blood sample 6 weeks after the fourth dose of the vaccine
Third blood sample 1 year after the fourth dose of the vaccine

Primary outcomes

Vaccine Immunity

Time frame: after the fourth dose of MenbVac

Assessment of vaccine Immunity with measure of percentage of children who have hSBA title >= 4 six weeks after the fourth dose of vaccine

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

Direction Générale de la Santé, France
Institut Pasteur

Registry information

Official study title

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

Acronym: Exten Effivac

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jun 18, 2012
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed