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

Tracking Information

First Received Date ^ICMJE

October 18, 2011

Last Updated Date

April 16, 2013

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01456715 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Human Papillomavirus

Intervention ^ICMJE

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
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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

416

Estimated Completion Date

December 2018

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

12 Years to 14 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01456715

Other Study ID Numbers ^ICMJE

122.05.01, 9427-L1802/1-21C

Has Data Monitoring Committee

Responsible Party

Vladimir Gilca, Laval University

Study Sponsor ^ICMJE

Laval University

Collaborators ^ICMJE

Quebec Ministry of Health and Social Services
Quebec Public Health Institute
Laval University Research Hospital Center

Investigators ^ICMJE

Principal Investigator:

Vladimir Gilca, MD, PhD

INSPQ, CHUQ-CHUL, Laval University

Information Provided By

Laval University

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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