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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
418
Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later.
Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later.
Laval University Research Hospital Center
Québec, Canada
Antibody to HPV
The effect of a booster dose of Gardasil or Cervarix administered randomly (1:1) to subjects vaccinated 42 months before with two doses of Gardasil.
Time frame: 1 month post booster dose
Safety of a booster dose of Gardasil and Cervarix administered 42 months after the second dose of Gardasil.
Time frame: Solicited adverse events 5 days post vaccine administration. Serious adverse events during the study period.
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