Primary Outcome Measures:
- Seroconversion rates to HPV-16 and HPV-18 as assessed by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: At Month 7 ]
Secondary Outcome Measures:
- Occurrence of SAEs [ Time Frame: Throughout the study period (up to Month 7) ]
- Occurrence, intensity and relationship to vaccination of solicited general symptoms, and occurrence and intensity
of solicited local symptoms [ Time Frame: During the 7 days after each and any vaccination ]
- Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms [ Time Frame: Within 30 days after any vaccination ]
- Occurrence of new onset chronic diseases and other medically significant conditions regardless of causal
relationship to vaccination and intensity. [ Time Frame: Throughout the study period (up to Month 7) ]
- Anti-HPV-16/18 antibody titres (by ELISA) [ Time Frame: At Month 0 and Month 7 ]
The protocol was primarily amended for the following reason:
Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming commercially available in an increasing number of countries. Therefore, the study procedures were revised to include questions at every visit to determine if subjects have received an HPV vaccine outside of the study.