Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Vaccinated With MenBVac® (Extension MenbVac)

Phase 3

Completed

• Conditions: Vaccination With MenbVac
• Interventions: Biological: MenbVac

• Registration Number: NCT01565577
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-26
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-28
• Study Start: 2012-04
• Primary Completion: 2012-06
• Study Completion: 2012-09
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-05
• Last Update Posted: 2014-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bras A	MenbVac	-

Primary Outcome Measures

Name	Time	Method
vaccine Immunity	two and a half years after the fouth vaccination	assessment of vaccine Immunity with measure of percentage of children with an hSBA title \>= 4 four years after four doses of MenbVac

Trial Locations

Locations (1)

UH-rouen; 🇫🇷 Rouen,, Seine Maritime, France