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OpenTrials
Completed

NCT Number: NCT01456715

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

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.

Completed

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Key information

Conditions

Human Papillomavirus

Age range

12 year–14 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Laval University Research Hospital Center

Québec, G1E7G9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gardasil vaccine, Immunogenicity, Booster dose.

Biological

Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later.

Other names: HPV vaccine

Cervarix Vaccine, Immunogenicity, Booster Dose.

Biological

Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later.

Other names: HPV vaccine.

Primary outcomes

  1. Antibody to HPV

    Time frame: 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Oct 21, 2011
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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