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

NCT01621945 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

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 fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.

Conditions

  • Neisseria Meningitidis

Interventions

BIOLOGICAL

MenBvac

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

Sponsors & Collaborators

  • Direction Générale de la Santé, France

    collaborator OTHER

  • Institut Pasteur

    collaborator INDUSTRY

  • University Hospital, Rouen

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-04-30
Completion
2013-09-30

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 NCT01621945 on ClinicalTrials.gov