NCT01621945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 12, 2026

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

March 26, 2012

Last Update Submit

June 9, 2026

Conditions

Neisseria Meningitidis

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Vaccine Immunity

    Assessment of vaccine Immunity with measure of percentage of children who have hSBA title \>= 4 six weeks after the fourth dose of vaccine

    after the fourth dose of MenbVac

Study Arms (1)

Bras A

EXPERIMENTAL

children, born between the 06/04/2004 and the 17/04/2008, living around Neufchatel en Bray, before the fourth dose of MenBVac

Biological: MenBvac

Interventions

MenBvacBIOLOGICAL

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

Bras A

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • no parental authority(ies)assent,
  • no blood sample,
  • impossibility of fourth vaccination,
  • children yet vaccinated or non eligible for vaccination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison Du Département

Neufchâtel-en-Bray, 76270, France

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

June 18, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

September 1, 2013

Last Updated

June 12, 2026

Record last verified: 2014-09

Locations

FR(1)