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

Laval University

Status and phase: Completed; Phase 3

Conditions: Human Papillomavirus

Treatments: Biological: Cervarix Vaccine, Immunogenicity, Booster Dose.; Biological: Gardasil vaccine, Immunogenicity, Booster dose.

Study type: Interventional

Funder types: Other

Identifiers

NCT01456715

9427-L1802/1-21C (Other Identifier)

122.05.01

Details and patient eligibility

About

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.

Enrollment: 418 patients

Sex: Female

Ages: 12 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In 2008-2009 received two doses of Gardasil at the age of 9-10 years according to 0, 6 months schedule.

Exclusion criteria

• Received less than two doses of Gardasil or received an HPV vaccine outside the study protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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418 participants in 2 patient groups

Gardasil, Immunogenicity, Booster dose.

Active Comparator group

Treatment:

Biological: Gardasil vaccine, Immunogenicity, Booster dose.

Cervarix, Immunogenicity, Booster dose.

Experimental group

Treatment:

Biological: Cervarix Vaccine, Immunogenicity, Booster Dose.