Trials / Completed
CompletedNCT00514904
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,504 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 2 Years – 10 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nimenrix | Single dose, intramuscular injection |
| BIOLOGICAL | Mencevax | Single dose, subcutaneous injection |
Timeline
- Start date
- 2007-09-18
- Primary completion
- 2008-09-03
- Completion
- 2009-01-06
- First posted
- 2007-08-10
- Last updated
- 2020-10-27
- Results posted
- 2017-10-06
Locations
7 sites across 4 countries: India, Lebanon, Philippines, Saudi Arabia
Source: ClinicalTrials.gov record NCT00514904. Inclusion in this directory is not an endorsement.