Trials / Completed
CompletedNCT00126945
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
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 15 Years – 19 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Meningococcal Vaccine |
Timeline
- Start date
- 2005-08-01
- Completion
- 2005-10-01
- First posted
- 2005-08-05
- Last updated
- 2016-09-21
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00126945. Inclusion in this directory is not an endorsement.