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

Phase 3

Completed

• Conditions: Human Papillomavirus
• Interventions: Biological: Cervarix Vaccine, Immunogenicity, Booster Dose.; Biological: Gardasil vaccine, Immunogenicity, Booster dose.

• Registration Number: NCT01456715
• Lead Sponsor: Laval University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 418

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervarix, Immunogenicity, Booster dose.	Cervarix Vaccine, Immunogenicity, Booster Dose.	-
Gardasil, Immunogenicity, Booster dose.	Gardasil vaccine, Immunogenicity, Booster dose.	-

Primary Outcome Measures

Name	Time	Method
Antibody to HPV	1 month post booster dose	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.

Secondary Outcome Measures

Name	Time	Method
Safety of a booster dose of Gardasil and Cervarix administered 42 months after the second dose of Gardasil.	Solicited adverse events 5 days post vaccine administration. Serious adverse events during the study period.

Trial Locations

Locations (1)

Laval University Research Hospital Center; 🇨🇦 Quebec, Canada