Infections, Meningococcal Clinical Trial
Official title:
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
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.
Multicentre study with 5 treatment groups. Three groups will receive three different
manufactured lots of GSK134612, one group will receive one lot of GSK134612 given in an
experimental co-administration with Fluarix™, the control group will receive Mencevax™. The
study will be conducted in a double-blind manner with respect to the 3 lots of GSK134612
vaccine. The study will be 'open' between the groups receiving GSK134612 and the group
receiving GSK134612 + Fluarix™ and the Mencevax™ group.
Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to
vaccination and one taken 30 days later.
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