Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 in Patients Having to be Vaccinated MenBVac® (Extension EFFIVAC)

Neisseria Meningitidis Clinical Trial

— Exten Effivac  

Official title:

Phase 3, Vaccinal Activity Assessment of MenBVac Against Neisseria Meningitidis B:14,P1.7,16 Strain in Child

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621945
• Other study ID #: 2011/198/HP
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2012
• Last updated: September 5, 2014
• Start date: April 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2014
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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 fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

• children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray,and Having participated to the first study,

• children who Have to be Vaccinated MenBVac® for the four times,

• parental authority(ies)assent.

Exclusion Criteria:

• no parental authority(ies)assent,

• no blood sample,

• impossibility of fourth vaccination,

• children yet vaccinated or non eligible for vaccination.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neisseria Meningitidis

Intervention

Biological:
• MenBvac
Blood test

Locations

Country	Name	City	State
France	Maison Du Département	Neufchâtel En Bray

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Rouen	Direction Générale de la Santé, France, Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine Immunity	Assessment of vaccine Immunity with measure of percentage of children who have hSBA title >= 4 six weeks after the fourth dose of vaccine	after the fourth dose of MenbVac	No