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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Quebec Ministry of Health and Social Services
Quebec Public Health Institute
Laval University Research Hospital Center
Information provided by (Responsible Party):
Vladimir Gilca, Laval University
ClinicalTrials.gov Identifier:
NCT01456715
First received: October 18, 2011
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Human Papillomavirus
 Biological: Gardasil vaccine, Immunogenicity, Booster dose.
Biological: Cervarix Vaccine, Immunogenicity, Booster Dose.
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Antibody to HPV [ Time Frame: 1 month post booster dose ] [ Designated as safety issue: No ]
    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:
  • Safety of a booster dose of Gardasil and Cervarix administered 42 months after the second dose of Gardasil. [ Time Frame: Solicited adverse events 5 days post vaccine administration. Serious adverse events during the study period. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 416
Study Start Date: September 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gardasil, Immunogenicity, Booster dose. 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.
Other Name: HPV vaccine
Experimental: Cervarix, Immunogenicity, Booster dose. 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.
Other Name: HPV vaccine.

  Eligibility

Ages Eligible for Study:   12 Years to 14 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456715

Locations
Canada
Laval University Research Hospital Center
Quebec, Canada, G1E7G9
Sponsors and Collaborators
Laval University
Quebec Ministry of Health and Social Services
Quebec Public Health Institute
Laval University Research Hospital Center
Investigators
Principal Investigator: Vladimir Gilca, MD, PhD INSPQ, CHUQ-CHUL, Laval University
  More Information

No publications provided

Responsible Party: Vladimir Gilca, Principal investigator, Laval University
ClinicalTrials.gov Identifier: NCT01456715     History of Changes
Other Study ID Numbers: 122.05.01, 9427-L1802/1-21C
Study First Received: October 18, 2011
Last Updated: April 16, 2013
Health Authority: Canada: Quebec Public Health Institute

Keywords provided by Laval University:
Human Papillomavirus Vaccines
Immunogenicity Gardasil Cervarix
Booster dose

ClinicalTrials.gov processed this record on May 16, 2013