NCT01054053

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

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

Study Start

First participant enrolled

April 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 23, 2012

Status Verified

March 1, 2012

Enrollment Period

1.5 years

First QC Date

November 26, 2009

Last Update Submit

March 22, 2012

Conditions

Vaccination

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

1

children born between 06/04/2004 and 17/04/2008 and called to menBvac vaccination and living around Neufchatel en Bray.

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children born between 06/04/2004 and 17/04/2008, living Neufchatel en bray.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison Du Département

Neufchâtel-en-Bray, 76270, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2009

First Posted

January 22, 2010

Study Start

April 1, 2009

Primary Completion

October 1, 2010

Study Completion

January 1, 2011

Last Updated

March 23, 2012

Record last verified: 2012-03

Locations

FR(1)