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.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: August 4, 2005
Last updated: January 22, 2015
Last verified: January 2015
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
Infections, Meningococcal
Biological: Meningococcal Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Primary Vaccination Study to 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 Years

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • Antibodies to MenACWY before + 1 m after dose 1, 12 m after dose 1 in control + with selected vaccine groups, 1 m after booster
  • Solicited, unsolicited symptoms after each dose and serious adverse events (SAEs)

Enrollment: 125
Study Start Date: August 2005
Detailed Description:
The study is open. However, the 4 different formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner. Mencevax™ ACWY vaccine will serve as active control. Subjects will receive one vaccine dose only (GSK's MenACWY conjugate vaccine or Mencevax™ ACWY vaccine), and will have 2 blood samples taken, before and one month after vaccination.

Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male or female between, and including, 15 and 19 years of age at the time of vaccination.
  • 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.

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00126945

GSK Investigational Site
Aarhus N, Denmark, 8200
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00126945     History of Changes
Other Study ID Numbers: 104702 
Study First Received: August 4, 2005
Last Updated: January 22, 2015
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by GlaxoSmithKline:
Meningococcal serogroups A, C, W-135, Y disease

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2016