Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Have to be Vaccinated MenBVac®

NCT01054053 | Completed Phase 4 DMC

• 1 other identifier: 2009/042/HP
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination

Keywords

Neisseria meningitidis B:14, P1-7, 16; Serum bactericidal activity; Menbvac

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)

MenBVac Vaccination Group

EXPERIMENTAL

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

Biological: MenBVac Vaccination

Interventions

MenBVac Vaccination BIOLOGICAL

* First blood sample prior to vaccination with MenBVac * First and second doses of MenBVac * Second blood sample 6 weeks after the second dose of the vaccine * Third blood sample immediatly before the third dose of the vaccine * Third dose of MenBVac * Fourth blood sample 6 weeks after the third dose of the vaccine * Fifth blood sample one year after the third dose of the vaccine

MenBVac Vaccination Group

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Institut Pasteur: collaborator

Study Sites (1)

Maison Du Département

Neufchâtel-en-Bray, 76270, France

Location

Related Publications (1)

• Caron F, Delbos V, Houivet E, Deghmane AE, Leroy JP, Hong E, Benichou J, Taha MK. Evolution of immune response against Neisseria meningitidis B:14:P1.7,16 before and after the outer membrane vesicle vaccine MenBvac. Vaccine. 2012 Jul 20;30(34):5059-62. doi: 10.1016/j.vaccine.2012.05.051. Epub 2012 May 30.

  PMID: 22658929 RESULT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• 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: June 12, 2026

Record last verified: 2012-03

Locations

FR (1)