NCT00450554

Brief Summary

The main objective of the study is to estimate the proportion of children, born between the 01/01/2002 and the 06/23/200, living around Dieppe (cantons Dieppe est, Dieppe Ouest and Offranville), vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (\>= 4), before and after the third MenBvac vaccination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

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

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

1.2 years

First QC Date

March 19, 2007

Last Update Submit

March 26, 2012

Conditions

Vaccination

Keywords

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

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville

You may qualify if:

  • children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated twice 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH-rouen

Rouen, Seine Maritime, 76000, France

Location

Study Officials

  • CARON François, Professor

    Service des Maladies Intectieuses et Tropicales

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 22, 2007

Study Start

February 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 27, 2012

Record last verified: 2012-03

Locations

FR(1)