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Immunogenicity and Safety of Gardasil-9 and Cervarix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02567955
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Laval University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HPV Vaccines Immunogenicity and Safety Biological: Immunogenicity two doses of Gardasil-9 Biological: Immunogenicity Cervarix and Gardasil-9 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Gardasil-9 and Cervarix When Administered to 9-10-year-old Subjects According to 0-6 Month Schedule
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 2017
Arms and Interventions
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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 Name: 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 Name: HPV vaccine


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   9 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 9-10-year-old girls and boys

Exclusion Criteria:

  • previously received an HPV vaccine
  • immunosuppressed
  • known allergy to a vaccine component
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567955


Locations
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Canada
Équipe de recherche en vaccination
Quebec, Canada, G1E7G9
Sponsors and Collaborators
Laval University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT02567955    
Other Study ID Numbers: HPV 2355
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Keywords provided by Laval University:
HPV vaccines, interchangeable use
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs