Immunogenicity and Safety of Gardasil-9 and Cervarix
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ClinicalTrials.gov Identifier: NCT02567955 |
Recruitment Status :
Completed
First Posted : October 5, 2015
Last Update Posted : January 18, 2019
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Condition or disease | Intervention/treatment | Phase |
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HPV Vaccines Immunogenicity and Safety | Biological: Immunogenicity two doses of Gardasil-9 Biological: Immunogenicity Cervarix and Gardasil-9 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 376 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Immunogenicity and Safety of Gardasil-9 and Cervarix When Administered to 9-10-year-old Subjects According to 0-6 Month Schedule |
Actual Study Start Date : | September 2015 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | November 2017 |

Arm | Intervention/treatment |
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Active Comparator: Immunogenicity two doses of Gardasil-9
Subjects will receive two doses of Gardasil-9
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Biological: Immunogenicity two doses of Gardasil-9
Subjects will receive two standard doses of Gardasil-9 (0.5 ml)
Other Name: HPV vaccine |
Experimental: Immunogenicity Cervarix and Gardasil-9
Subjects will receive a dose Cervarix and a dose Gardasil-9
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Biological: 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)
Other Name: HPV vaccine |
- 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 ]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.
- Comparison of tolerability profile of Gardasil-9 and Cervarix [ Time Frame: 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.

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Ages Eligible for Study: | 9 Years to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567955
Canada | |
Équipe de recherche en vaccination | |
Quebec, Canada, G1E7G9 |
Responsible Party: | Laval University |
ClinicalTrials.gov Identifier: | NCT02567955 |
Other Study ID Numbers: |
HPV 2355 |
First Posted: | October 5, 2015 Key Record Dates |
Last Update Posted: | January 18, 2019 |
Last Verified: | January 2019 |
HPV vaccines, interchangeable use |
Vaccines Immunologic Factors Physiological Effects of Drugs |