We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01565577
First Posted: March 28, 2012
Last Update Posted: September 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Direction Générale de la Santé, France
Institut Pasteur
Dieppe
Information provided by (Responsible Party):
University Hospital, Rouen
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01565577     History of Changes
Other Study ID Numbers: 2011/199/HP
First Submitted: March 26, 2012
First Posted: March 28, 2012
Last Update Posted: September 8, 2014
Last Verified: September 2014

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