Immunogenicity and Safety of Gardasil-9 and Cervarix

Laval University

Status and phase: Completed; Phase 3

Conditions: HPV Vaccines Immunogenicity and Safety

Treatments: Biological: Immunogenicity Cervarix and Gardasil-9; Biological: Immunogenicity two doses of Gardasil-9

Study type: Interventional

Funder types: Other

Identifiers

NCT02567955

HPV 2355

Details and patient eligibility

About

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.

Full 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.

Enrollment: 376 patients

Sex: All

Ages: 9 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 9-10-year-old girls and boys

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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376 participants in 2 patient groups

Immunogenicity two doses of Gardasil-9

Active Comparator group

Description:

Subjects will receive two doses of Gardasil-9

Treatment:

Biological: Immunogenicity two doses of Gardasil-9

Immunogenicity Cervarix and Gardasil-9

Experimental group

Description:

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

Treatment:

Biological: Immunogenicity Cervarix and Gardasil-9