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:
NCT00126945
First received: August 4, 2005
Last updated: September 29, 2011
Last verified: September 2011
  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
Meningitis
Meningococcal Infection
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 Yrs

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)

Estimated Enrollment: 125
Study Start Date: August 2005
Intervention Details:
    Biological: Meningococcal Vaccine
    Other Name: Meningococcal Vaccine
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.

  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.
  • 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.
  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: NCT00126945

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

Publications:
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00126945     History of Changes
Other Study ID Numbers: 104702
Study First Received: August 4, 2005
Last Updated: September 29, 2011
Health Authority: Denmark: Danish Medicines Agency

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

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on October 22, 2014