Immunogenicity and Safety of Gardasil-9 and Cervarix

Phase 3

Completed

• Conditions: HPV Vaccines Immunogenicity and Safety
• Interventions: Biological: Immunogenicity two doses of Gardasil-9; Biological: Immunogenicity Cervarix and Gardasil-9

• Registration Number: NCT02567955
• Lead Sponsor: Laval University

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-05
• Primary Completion: 2016-09
• Study Completion: 2017-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

• 9-10-year-old girls and boys

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunogenicity two doses of Gardasil-9	Immunogenicity two doses of Gardasil-9	Subjects will receive two doses of Gardasil-9
Immunogenicity Cervarix and Gardasil-9	Immunogenicity Cervarix and Gardasil-9	Subjects will receive a dose Cervarix and a dose Gardasil-9

Primary Outcome Measures

Name	Time	Method
Comparison of proportion of subjects with detectable antibodies to 9 HPV genotypes included in the Gardasil-9 vaccine observed in two study arms	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

Name	Time	Method
Comparison of tolerability profile of Gardasil-9 and Cervarix	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.

Trial Locations

Locations (1)

Équipe de recherche en vaccination; 🇨🇦 Quebec, Canada