Immunogenicity and Safety of Gardasil-9 and Cervarix

HPV Vaccines Immunogenicity and Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567955
• Other study ID #: HPV 2355
• Status: Completed
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: November 2017

Study information

• Verified date: January 2019
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: November 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 10 Years

Eligibility

Inclusion Criteria:

• 9-10-year-old girls and boys

Exclusion Criteria:

• previously received an HPV vaccine

• immunosuppressed

• known allergy to a vaccine component

Related Conditions & MeSH terms

• HPV Vaccines Immunogenicity and Safety

Intervention

Biological:
• Immunogenicity two doses of Gardasil-9
Subjects will receive two standard doses of Gardasil-9 (0.5 ml)
• 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)

Locations

Country	Name	City	State
Canada	Équipe de recherche en vaccination	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of proportion of subjects with detectable antibodies to 9 HPV genotypes included in the Gardasil-9 vaccine observed in two study arms	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.	36 months post-second dose of vaccine
Secondary	Comparison of tolerability profile of Gardasil-9 and Cervarix	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.	During 5 days after each vaccine dose administration.