Immunogenicity and Safety of Gardasil-9 and Cervarix

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02567955
• Date of registration: 01/10/2015
• Prospective Registration: No
• Primary sponsor: Laval University
• Public title: Immunogenicity and Safety of Gardasil-9 and Cervarix
• Scientific title: Immunogenicity and Safety of Gardasil-9 and Cervarix When Administered to 9-10-year-old Subjects According to 0-6 Month Schedule
• Date of first enrolment: September 2015
• Target sample size: 376
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02567955
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

- 9-10-year-old girls and boys

Exclusion Criteria:

- previously received an HPV vaccine

- immunosuppressed

- known allergy to a vaccine component



Age minimum: 9 Years
Age maximum: 10 Years
Gender: All

Health Condition(s) or Problem(s) studied

HPV Vaccines Immunogenicity and Safety

Intervention(s)

Biological: Immunogenicity two doses of Gardasil-9

Biological: Immunogenicity Cervarix and Gardasil-9

Primary Outcome(s)

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]

Secondary Outcome(s)

Comparison of tolerability profile of Gardasil-9 and Cervarix [Time Frame: During 5 days after each vaccine dose administration.]

Secondary ID(s)

HPV 2355

Source(s) of Monetary Support

Please refer to primary and secondary sponsors