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

NCT01456715 | Completed Phase 3

• 2 other identifiers: 122.05.019427-L1802/1-21C
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus

Keywords

Human Papillomavirus Vaccines; Immunogenicity Gardasil Cervarix; Booster dose

Outcome Measures

Primary Outcomes (1)

• Antibody to HPV

  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.

  1 month post booster dose

Secondary Outcomes (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.

Study Arms (2)

Gardasil, Immunogenicity, Booster dose.

ACTIVE COMPARATOR

Biological: Gardasil vaccine, Immunogenicity, Booster dose.

Cervarix, Immunogenicity, Booster dose.

EXPERIMENTAL

Biological: Cervarix Vaccine, Immunogenicity, Booster Dose.

Interventions

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.

Also known as: HPV vaccine

Gardasil, Immunogenicity, Booster dose.

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.

Also known as: HPV vaccine.

Cervarix, Immunogenicity, Booster dose.

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• In 2008-2009 received two doses of Gardasil at the age of 9-10 years according to 0, 6 months schedule.

You may not qualify if:

• Received less than two doses of Gardasil or received an HPV vaccine outside the study protocol.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Laval University Research Hospital Center

Québec, G1E7G9, Canada

Location

MeSH Terms

Interventions

Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Vladimir Gilca, MD, PhD

  INSPQ, CHUQ-CHUL, Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 21, 2011
• Study Start: September 1, 2008
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

CA (1)