Human Papillomavirus Clinical Trial
Official title:
Immunogenicity and Safety of Gardasil and Twinrix Vaccines Co-administered or Administered a Month Apart, According to the 0, 6 Months Schedule and the Effect of a Third Dose of Gardasil or Cervarix Administered 42 Months Later.
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.
n/a
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