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

Sponsor
Laval University (Other)
Overall Status
Completed
CT.gov ID
NCT01456715
Collaborator
(none)
418
Enrollment
1
Location
2
Arms
123
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Gardasil vaccine, Immunogenicity, Booster dose.
  • Biological: Cervarix Vaccine, Immunogenicity, Booster Dose.
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
418 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
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.
Actual Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • HPV vaccine.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.]

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 Laval University Research Hospital Center Quebec Canada G1E7G9

    Sponsors and Collaborators

    • Laval University

    Investigators

    • Principal Investigator: Vladimir Gilca, MD, PhD, INSPQ, CHUQ-CHUL, Laval University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vladimir Gilca, Principal investigator, Laval University
    ClinicalTrials.gov Identifier:
    NCT01456715
    Other Study ID Numbers:
    • 122.05.01
    • 9427-L1802/1-21C
    First Posted:
    Oct 21, 2011
    Last Update Posted:
    Mar 5, 2020
    Last Verified:
    Mar 1, 2020
    Keywords provided by Vladimir Gilca, Principal investigator, Laval University
    Human Papillomavirus Vaccines
    Immunogenicity Gardasil Cervarix
    Booster dose
    Additional relevant MeSH terms:
    Vaccines

    Study Results

    No Results Posted as of Mar 5, 2020