Immunogenicity and Safety of Gardasil-9 and Cervarix

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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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety Vaccines

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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 :

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gilca V, Sauvageau C, Panicker G, De Serres G, Schiller J, Ouakki M, Unger ER. Long intervals between two doses of HPV vaccines and magnitude of the immune response: a post hoc analysis of two clinical trials. Hum Vaccin Immunother. 2019;15(7-8):1980-1985. doi: 10.1080/21645515.2019.1605278. Epub 2019 Jun 3.

Gilca V, Sauvageau C, Panicker G, De Serres G, Ouakki M, Unger ER. Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine - A randomized clinical trial. Vaccine. 2018 Nov 12;36(46):7017-7024. doi: 10.1016/j.vaccine.2018.09.057. Epub 2018 Oct 9.

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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

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