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

Phase 3CompletedNCT01621945

University Hospital, Rouen120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

120

Conditions

Neisseria Meningitidis

Interventions

MenBvacBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Maison Du Département

Neufchâtel-en-Bray, France

Outcomes

Primary Outcomes

Vaccine Immunity

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

Time frame: after the fourth dose of MenbVac

Data from ClinicalTrials.gov

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