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

L

Laval University

Status and phase

Completed
Phase 3

Conditions

Human Papillomavirus

Treatments

Biological: Cervarix Vaccine, Immunogenicity, Booster Dose.
Biological: Gardasil vaccine, Immunogenicity, Booster dose.

Study type

Interventional

Funder types

Other

Identifiers

NCT01456715
9427-L1802/1-21C (Other Identifier)
122.05.01

Details and patient eligibility

About

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.

Enrollment

418 patients

Sex

Female

Ages

12 to 14 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

418 participants in 2 patient groups

Gardasil, Immunogenicity, Booster dose.
Active Comparator group
Treatment:
Biological: Gardasil vaccine, Immunogenicity, Booster dose.
Cervarix, Immunogenicity, Booster dose.
Experimental group
Treatment:
Biological: Cervarix Vaccine, Immunogenicity, Booster Dose.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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