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)

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.
ClinicalTrials.gov Identifier: NCT01565577
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : September 8, 2014
Sponsor:
Collaborators:
Direction Générale de la Santé, France
Institut Pasteur
Dieppe
Information provided by (Responsible Party):
University Hospital, Rouen

March 26, 2012
March 28, 2012
September 8, 2014
April 2012
June 2012   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01565577 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Vaccinated With MenBVac® (Extension MenbVac)
Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac®
This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Vaccination With MenbVac
Biological: MenbVac
Blood test
Experimental: Bras A
Intervention: Biological: MenbVac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
117
235
September 2012
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
7 Years to 12 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01565577
2011/199/HP
No
Not Provided
Not Provided
University Hospital, Rouen
University Hospital, Rouen
  • Direction Générale de la Santé, France
  • Institut Pasteur
  • Dieppe
Principal Investigator: François Caron, Professor CHU - Hôpitaux de Rouen
University Hospital, Rouen
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP