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OpenTrials
Completed

NCT Number: NCT01565577

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

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

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Key information

Conditions

Vaccination With MenbVac

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UH-rouen

Rouen, Seine Maritime, 76000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MenBvac

Biological

Blood test

Primary outcomes

  1. vaccine Immunity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • Dieppe
  • Direction Générale de la Santé, France
  • Institut Pasteur

Registry information

Official study title

Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac®

Acronym: Exten MenbVac

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 28, 2012
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.