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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01456715
Study type Interventional
Source Laval University
Contact
Status Completed
Phase Phase 3
Start date September 2008
Completion date December 2018

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