A phase I, open label, single-centre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine, administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female subjects aged 15 - 45 years.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary Outcome Measures:
- The occurrence of any SAEs [ Time Frame: Throughout the study period ]
- The occurrence of any and Grade 3 solicited local symptoms [ Time Frame: During the 7-day period following each vaccination ]
- The occurrence of any, Grade 3 and causally related to vaccination solicited general symptoms [ Time Frame: During the 7-day period following each vaccination ]
- The occurrence of any, Grade 3 and causally related to vaccination unsolicited AEs [ Time Frame: During the 30-day period following each vaccination ]
- Occurrence of clinically relevant abnormalities in biochemical and haematological parameters [ Time Frame: At Months 0 and 7 ]
- The occurrence of medically significant conditions regardless of causal relationship to vaccination and intensity. [ Time Frame: Throughout the study period ]
Estimated Enrollment: |
30 |
Study Start Date: |
December 2007 |
Estimated Primary Completion Date: |
August 2008 (Final data collection date for primary outcome measure) |
The rationale for the protocol posting amendment was to change the study population from 18-35 to 15-45 years and to allow subjects who were administered routine vaccines e.g. Hepatitis A&B vaccines, meningococcal vaccines, Tetanus vaccine, DTP etc. up to 8 days before each HPV dose.