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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01054053

Acronym

EFFIVAC

Enrollment

218

Registered

2010-01-22

Start date

2009-04-01

Completion date

2011-01-01

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

Vaccination

Keywords

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

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 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.

Interventions

BIOLOGICALMenBVac 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 5 Years

Healthy volunteers

Yes

Inclusion criteria

* children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray, vaccinated five times by MenBVac * parental authority(ies)assent

Exclusion criteria

* no parental authority(ies)assent * no blood sample during the third vaccination * impossibility of third vaccination * children with guardianship * children yet vaccinated or non eligible for vaccination

Design outcomes

Primary

Measure	Time frame
assessment of natural Immunity with measure of percent of children who have hSBA title >= 4 at TO. assessment of antibodies blood persistence during measurement of percent of children who have hSBA title >= 4	18 months

Countries

France

Outcome results

None listed

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