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

NCT01054053 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2026-06-12

No results posted yet for this study

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.

Conditions

  • Vaccination

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

Sponsors & Collaborators

  • Institut Pasteur

    collaborator INDUSTRY

  • University Hospital, Rouen

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-10-31
Completion
2011-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01054053 on ClinicalTrials.gov