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

Human Papillomavirus Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456715
• Other study ID #: 122.05.01
• Secondary ID: 9427-L1802/1-21C
• Status: Completed
• Phase: Phase 3
• Start date: September 2008
• Est. completion date: December 2018

Study information

• Verified date: March 2020
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Laval University Research Hospital Center	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody to HPV	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.	1 month post booster dose
Secondary	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.