Immunogenicity and Safety of Gardasil-9 and Cervarix

NCT ID: NCT02567955

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-11-30

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.

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.

Conditions

HPV Vaccines Immunogenicity and Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Immunogenicity two doses of Gardasil-9

Subjects will receive two doses of Gardasil-9

Group Type: ACTIVE_COMPARATOR

Immunogenicity two doses of Gardasil-9

Intervention Type: BIOLOGICAL

Subjects will receive two standard doses of Gardasil-9 (0.5 ml)

Immunogenicity Cervarix and Gardasil-9

Subjects will receive a dose Cervarix and a dose Gardasil-9

Group Type: EXPERIMENTAL

Immunogenicity Cervarix and Gardasil-9

Intervention Type: BIOLOGICAL

Subjects will receive a standard dose of Cervarix (0.5 ml) and a standard dose of Gardasil-9 (0.5 ml)

Interventions

Immunogenicity two doses of Gardasil-9

Subjects will receive two standard doses of Gardasil-9 (0.5 ml)

Intervention Type: 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)

Intervention Type: BIOLOGICAL

Other Intervention Names

HPV vaccine; HPV vaccine

Eligibility Criteria

Inclusion Criteria

• 9-10-year-old girls and boys

Exclusion Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Équipe de recherche en vaccination

Québec, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 31017850 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30314913 (View on PubMed)

Other Identifiers

HPV 2355

Identifier Type: -

Identifier Source: org_study_id