Status and phase
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Study type
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About
Two human papillomavirus vaccines are now commercially available.
No clinical data exist regarding:
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.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
418 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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