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Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Vaccinated With MenBVac® (Extension MenbVac)

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01565577
Acronym
Exten MenbVac
Enrollment
117
Registered
2012-03-28
Start date
2012-04-01
Completion date
2012-09-01
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccination With MenbVac

Keywords

Neisseria meningitidis B:14, P1-7, 16, Serum bactericidal activity, Menbvac

Brief summary

This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.

Interventions

BIOLOGICALMenbVac

Blood test

Sponsors

University Hospital, Rouen
Lead SponsorOTHER
Direction Générale de la Santé, France
CollaboratorOTHER
Institut Pasteur
CollaboratorINDUSTRY
Dieppe
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated with four doses of MenBVac in the first MenbVac clinical trial study, * parental authority(ies)assent.

Exclusion criteria

* no parental authority(ies)assent, * no parental authority(ies)assent, * no blood sample during the third vaccination, * impossibility of third vaccination.

Design outcomes

Primary

MeasureTime frameDescription
vaccine Immunitytwo and a half years after the fouth vaccinationassessment of vaccine Immunity with measure of percentage of children with an hSBA title \>= 4 four years after four doses of MenbVac

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFrançois Caron, Professor

CHU - Hôpitaux de Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026