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

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.

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Key information

Conditions

Vaccination

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

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, 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

Treatment and study plan

MenBVac Vaccination

Biological

First blood sample prior to vaccination with MenBVac
First and second doses of MenBVac
Second blood sample 6 weeks after the second dose of the vaccine
Third blood sample immediatly before the third dose of the vaccine
Third dose of MenBVac
Fourth blood sample 6 weeks after the third dose of the vaccine
Fifth blood sample one year after the third dose of the vaccine

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

Institut Pasteur

Registry information

Official study title

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

Acronym: EFFIVAC

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Jan 22, 2010
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