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COMPLETED
NCT01054053
PHASE4

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

Sponsor: University Hospital, Rouen

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

1 Year - 5 Years

Study Type

INTERVENTIONAL

Enrollment

218

Start Date

2009-04

Completion Date

2011-01

Last Updated

2026-06-12

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

MenBVac Vaccination

* 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

Locations (1)

Maison Du Département

Neufchâtel-en-Bray, France