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

NCT01456715 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 418

Last updated 2020-03-05

No results posted yet for this study

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.

Conditions

  • Human Papillomavirus

Interventions

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.

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.

Sponsors & Collaborators

  • Laval University

    lead OTHER

Principal Investigators

  • Vladimir Gilca, MD, PhD · INSPQ, CHUQ-CHUL, Laval University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456715 on ClinicalTrials.gov