Immunogenicity and Safety of Gardasil-9 and Cervarix

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HPV Vaccines Immunogenicity and Safety

Intervention / Treatment
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* Biological: Immunogenicity two doses of Gardasil-9
* Biological: Immunogenicity Cervarix and Gardasil-9


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 9-10-year-old girls and boys Exclusion Criteria: previously received an HPV vaccine immunosuppressed known allergy to a vaccine component

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immunogenicity two doses of Gardasil-9<br>Subjects will receive two doses of Gardasil-9 | Biological: Immunogenicity two doses of Gardasil-9<br>* Subjects will receive two standard doses of Gardasil-9 (0.5 ml)<br>* Other names: HPV vaccine;|
| Experimental: Immunogenicity Cervarix and Gardasil-9<br>Subjects will receive a dose Cervarix and a dose Gardasil-9 | Biological: Immunogenicity Cervarix and Gardasil-9<br>* Subjects will receive a standard dose of Cervarix (0.5 ml) and a standard dose of Gardasil-9 (0.5 ml)<br>* Other names: HPV vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV vaccines, interchangeable use