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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02567955

Enrollment

376

Registered

2015-10-05

Start date

2015-09-30

Completion date

2017-11-30

Last updated

2019-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV Vaccines Immunogenicity and Safety

Keywords

HPV vaccines, interchangeable use

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.

Interventions

BIOLOGICALImmunogenicity two doses of Gardasil-9

Subjects will receive two standard doses of Gardasil-9 (0.5 ml)

BIOLOGICALImmunogenicity 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

9 Years to 10 Years

Healthy volunteers

Yes

Inclusion criteria

* 9-10-year-old girls and boys

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026