NCT02567955

Immunogenicity and Safety of Gardasil-9 and Cervarix

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 9 Years – 10 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Immunogenicity two doses of Gardasil-9	Subjects will receive two standard doses of Gardasil-9 (0.5 ml)
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)

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2017-11-01
• First posted: 2015-10-05
• Last updated: 2019-01-18

Locations

1 site across 1 country: Canada