Trials / Completed
CompletedNCT00464815
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,025 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 11 Years – 17 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
Detailed description
Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Meningococcal vaccine GSK134612 | One intramuscular dose |
| BIOLOGICAL | Mencevax™ ACWY | One subcutaneous dose |
Timeline
- Start date
- 2007-05-02
- Primary completion
- 2008-04-16
- Completion
- 2008-09-10
- First posted
- 2007-04-24
- Last updated
- 2018-06-08
- Results posted
- 2018-04-02
Locations
7 sites across 3 countries: India, Philippines, Taiwan
Source: ClinicalTrials.gov record NCT00464815. Inclusion in this directory is not an endorsement.