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Evaluate 4 Different Formulations of Meningococcal Serogroups A, C, W-135, Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00196963
First received: September 13, 2005
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy subjects aged 15-19 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.


Condition Intervention Phase
Meningococcal Serogroup Diseases
 Biological: Meningococcal (vaccine)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Assess the Immunogenicity, Safety, Reactogenicity of 1 Dose of 4 Different Formulations of GSK Biologicals' Meningococcal Conjugate Vaccine (MenACWY) vs 1 Dose of Mencevax™ ACWY in Healthy Subjects Aged 15-19 Yrs

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • % of serum bactericidal activity SBA-MenA, SBA-MenC, SBA-MenW-135 and SBA-MenY responders (i.e.>= 4-fold increase in SBA titre from pre to post vaccination) at 1 month after the vaccine dose.

Secondary Outcome Measures:
  • Prophylaxis meningococcal serogroups A, C, W-135, Y disease

Estimated Enrollment: 125
Study Start Date: March 2005
Intervention Details:
    Biological: Meningococcal (vaccine)
    Other Name: Meningococcal (vaccine)
Detailed Description:

3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or of the active control (Mencevax™ ACWY) will be done in an open manner. Subjects will receive one vaccine dose (GSK's MenACWY conjugate vaccine or Mencevax™ ACWY vaccine), and will have 2 blood samples taken, before and one month after vaccination.

  Eligibility

Ages Eligible for Study:   15 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination.
  • Written informed consent obtained. Subject with previously completed routine childhood vaccinations to the best of his/her knowledge or his/her parents'/guardians' knowledge.
  • Female subjects should be of non-childbearing potential, or abstinent, or using an adequate contraception.

Exclusion criteria:

  • Previous vaccination against OR history of OR exposure within previous 12 months to meningococcal serogroup A, C, W-135 or Y disease.
  • Administration of a tetanus vaccine within 6 months before study vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of any neurologic disorders or seizures.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196963

Locations
Belgium
GSK Investigational Site
Thuin, Belgium, 6530
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00196963     History of Changes
Other Study ID Numbers: 103532
Study First Received: September 13, 2005
Last Updated: September 29, 2011
Health Authority: Belgium : Directorate General for Medicinal Products, Bruxelles

ClinicalTrials.gov processed this record on October 16, 2012