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

This study has been completed.
Sponsor:
Collaborators:
Direction Générale de la Santé, France
Institut Pasteur
Dieppe
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01565577
First received: March 26, 2012
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Vaccination With MenbVac
Biological: MenbVac
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac®

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • vaccine Immunity [ Time Frame: two and a half years after the fouth vaccination ] [ Designated as safety issue: No ]
    assessment of vaccine Immunity with measure of percentage of children with an hSBA title >= 4 four years after four doses of MenbVac


Enrollment: 117
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bras A Biological: MenbVac
Blood test

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565577

Locations
France
UH-rouen
Rouen,, Seine Maritime, France, 76000
Sponsors and Collaborators
University Hospital, Rouen
Direction Générale de la Santé, France
Institut Pasteur
Dieppe
Investigators
Principal Investigator: François Caron, Professor CHU - Hôpitaux de Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01565577     History of Changes
Other Study ID Numbers: 2011/199/HP
Study First Received: March 26, 2012
Last Updated: September 5, 2014
Health Authority: France : Agence française de sécurité sanitaire des produits de santé

Keywords provided by University Hospital, Rouen:
Neisseria meningitidis B:14, P1-7, 16
Serum bactericidal activity
Menbvac

ClinicalTrials.gov processed this record on November 27, 2014