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 3, Vaccinal Activity Assessment of MenBVac Against Neisseria Meningitidis B:14,P1.7,16 Strain in Child

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01621945

Acronym

Exten Effivac

Enrollment

120

Registered

2012-06-18

Start date

2012-04-01

Completion date

2013-09-01

Last updated

2026-06-12

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

Conditions

Neisseria Meningitidis

Keywords

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

Brief 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.

Interventions

BIOLOGICALMenBvac

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 8 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Vaccine Immunity	after the fourth dose of MenbVac	Assessment of vaccine Immunity with measure of percentage of children who have hSBA title \>= 4 six weeks after the fourth dose of vaccine

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026