Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later.
Summary
Two human papillomavirus vaccines are now commercially available. No clinical data exist regarding: * The immunogenicity and safety of Gardasil and Twinrix when co-administered. * The immunogenicity and safety of Cervarix when administered to subjects previously vaccinated with Gardasil. The main objective of the first phase of this clinical trial was: • To assess and compare the immunogenicity of Gardasil and Twinrix Junior when co-administered or administered at one month interval according to a 0, 6 month schedule to 9-10 year-old girls. The main objective of the seconde phase of this clinical trial is: • To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil. Study Design \& Duration: Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study with two treatment groups. Duration of the study: Participants will be followed for the duration of 10 years post-primary vaccination. Number of Centres: One Center.
Timeline
- Start
- 2008-09
- Primary completion
- 2018-12
- Completion
- 2018-12