NCT01565577

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_3

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
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

June 2, 2026

Status Verified

September 1, 2014

Enrollment Period

2 months

First QC Date

March 26, 2012

Last Update Submit

June 1, 2026

Conditions

Vaccination With MenbVac

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • vaccine Immunity

    assessment of vaccine Immunity with measure of percentage of children with an hSBA title \>= 4 four years after four doses of MenbVac

    two and a half years after the fouth vaccination

Study Arms (1)

Bras A

EXPERIMENTAL
Biological: MenbVac

Interventions

MenbVacBIOLOGICAL

Blood test

Bras A

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH-rouen

Rouen, Seine Maritime, 76000, France

Location

Study Officials

  • François Caron, Professor

    CHU - Hôpitaux de Rouen

    PRINCIPAL INVESTIGATOR

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

March 28, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

June 2, 2026

Record last verified: 2014-09

Locations

FR(1)