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

Infections, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196963
• Other study ID #: 103532
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 20, 2016
• Start date: March 2005
• Est. completion date: July 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium : Directorate General for Medicinal Products, Bruxelles
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 19 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• Meningococcal (vaccine)

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Thuin

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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	Prophylaxis meningococcal serogroups A, C, W-135, Y disease

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