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

University Hospital, Rouen

Status and phase: Completed; Phase 3

Conditions: Vaccination With MenbVac

Treatments: Biological: MenbVac

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01565577

2011/199/HP

Details and patient eligibility

About

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

Enrollment: 117 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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117 participants in 1 patient group

Bras A

Experimental group

Treatment:

Biological: MenbVac