NCT01456715

Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later.

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: Laval University · Academic / Other
• Sex: Female
• Age: 12 Years – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	Gardasil vaccine, Immunogenicity, Booster dose.	Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later.
BIOLOGICAL	Cervarix Vaccine, Immunogenicity, Booster Dose.	Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later.

Timeline

• Start date: 2008-09-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2011-10-21
• Last updated: 2020-03-05

Locations

1 site across 1 country: Canada