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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunogenicity two doses of Gardasil-9 | Active Comparator | Subjects will receive two doses of Gardasil-9 |
|
| Immunogenicity Cervarix and Gardasil-9 | Experimental | Subjects will receive a dose Cervarix and a dose Gardasil-9 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunogenicity two doses of Gardasil-9 | Biological | Subjects will receive two standard doses of Gardasil-9 (0.5 ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Équipe de recherche en vaccination | Québec | G1E7G9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31017850 | Derived | Gilca V, Sauvageau C, Panicker G, De Serres G, Schiller J, Ouakki M, Unger ER. Long intervals between two doses of HPV vaccines and magnitude of the immune response: a post hoc analysis of two clinical trials. Hum Vaccin Immunother. 2019;15(7-8):1980-1985. doi: 10.1080/21645515.2019.1605278. Epub 2019 Jun 3. | |
| 30314913 | Derived |
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| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Immunogenicity Cervarix and Gardasil-9 | Biological | Subjects will receive a standard dose of Cervarix (0.5 ml) and a standard dose of Gardasil-9 (0.5 ml) |
|
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| Gilca V, Sauvageau C, Panicker G, De Serres G, Ouakki M, Unger ER. Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine - A randomized clinical trial. Vaccine. 2018 Nov 12;36(46):7017-7024. doi: 10.1016/j.vaccine.2018.09.057. Epub 2018 Oct 9. |