Immunogenicity and Safety of Gardasil-9 and Cervarix

January 15, 2019 updated by: Laval University

Immunogenicity and Safety of Gardasil-9 and Cervarix When Administered to 9-10-year-old Subjects According to 0-6 Month Schedule

A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data on immunogenicity and safety of interchangeable use of the ninevalent and the bivalent vaccine (Cervarix) are available. The main objective of this study is to assess the immunogenicity of ninevalent and bivalent HPV vaccines when administered to 9-10-year-old girls and boys according to 0-6 month schedule.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proportion of subjects with detectable antibodies and antibody geometrical mean titers to 9 HPV genotypes included in the Gardasil-9 vaccine will be assessed 1 and 6 months post-first dose and 1, 18 and 36 months post-second dose of vaccine.

Study Type

Interventional

Enrollment (Actual)

376

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1E7G9
        • Équipe de recherche en vaccination

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 9-10-year-old girls and boys

Exclusion Criteria:

  • previously received an HPV vaccine
  • immunosuppressed
  • known allergy to a vaccine component

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immunogenicity two doses of Gardasil-9
Subjects will receive two doses of Gardasil-9
Biological: Immunogenicity two doses of Gardasil-9
Subjects will receive two standard doses of Gardasil-9 (0.5 ml)
Other Names:
  • HPV vaccine
Experimental: Immunogenicity Cervarix and Gardasil-9
Subjects will receive a dose Cervarix and a dose Gardasil-9
Biological: Immunogenicity Cervarix and Gardasil-9
Subjects will receive a standard dose of Cervarix (0.5 ml) and a standard dose of Gardasil-9 (0.5 ml)
Other Names:
  • HPV vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of proportion of subjects with detectable antibodies to 9 HPV genotypes included in the Gardasil-9 vaccine observed in two study arms
Time Frame: 36 months post-second dose of vaccine
A Luminex Total IgG assay will be used to assess the presence of antibodies and antibody titers to 9 HPV genotypes included in the Gardasil-9 vaccine. Luminex Units will be used for the antibody titers assessment.
36 months post-second dose of vaccine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of tolerability profile of Gardasil-9 and Cervarix
Time Frame: During 5 days after each vaccine dose administration.
Local and general symptoms observed after each vaccine dose will be assessed by using a standardized diary card. Proportion of subjects who reported local and/or general symptoms will be compared.
During 5 days after each vaccine dose administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 1, 2015

First Posted (Estimate)

October 5, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV 2355

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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