At a glance
ClinicalIndex Comparison Record- ✓Age 18–55 years at vaccination
- ✓Healthy as established by medical history and clinical examination
- ✓Previously completed routine childhood vaccinations
- ✓Adequate contraception if female of childbearing potential: negative pregnancy test and contraception for 30 days prior and 2 months after vaccination
- ✕Any investigational or non-registered product (drug or vaccine) within 30 days before study vaccine
- ✕Chronic immunosuppressant or immune-modifying drug use (>14 days) within 6 months prior to vaccination
- ✕Any vaccine not in study protocol within 1 month of study vaccine
- ✕Prior meningococcal polysaccharide vaccine (serogroups A, C, W, Y) within 5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Lot-to-Lot Consistency, Non-Inferiority Versus Mencevax™ and Evaluation of the Co-Administration With Fluarix™ of GSK Biologicals' Meningococcal Vaccine GSK134612, in Healthy Subjects Aged 18 Through 55 Years of Age
In Brief
A Phase 3 clinical trial evaluating Meningococcal vaccine GSK134612, Mencevax™ACWY, and 1 other intervention for Infections, Meningococcal. Completed, enrolled 1,352 participants across 4 sites in 2 countries.
Detailed Summary
The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of GSK134612 compared to licensed meningococcal vaccine Mencevax™, the non-inferiority of GSK134612 when given in an experimental co-administration with Fluarix™ compared to GSK134612 given alone and the immunogenicity of GSK134612 given with Fluarix™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Timeline
Interventions
One intramuscular dose
One subcutaneous dose
One intramuscular dose