Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil

Study Overview
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Brief Summary
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To demonstrate that Gardasil® vaccine, when given to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months), results in anti-HPV type 16 and anti-HPV type 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is given on the standard 3-dose schedule of 0, 2, 6 months.

Detailed Description
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OBJECTIVES: Primary objective: To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-HPV 16 and anti-HPV 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months. Secondary objectives: To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-HPV 6 and anti-HPV 11 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months. To describe the safety profile of the administration of Gardasil® according to each of the four schedules by assessing: (i) immediate reactogenicity (reactions within 30 minutes after each injection); (ii) solicited (local reactogenicity and fever) and unsolicited events occurring during the first 7 days following each vaccination; (iii) serious adverse events occurring up to one month following the last dose of vaccine; (iv) deaths or adverse events occurring at any time determined to be vaccination-related.

Official Title
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Comparison of the Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil Vaccine to Prevent HPV Infection

Conditions
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Dose Schedule Study

Intervention / Treatment
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* Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 11-13 years of age. Signed informed consent form (both parent's & daughter's signature). Good health status. Able to comply with trial protocol. Plans to stay at current school for duration of study. Exclusion Criteria: Prior HPV vaccination Pregnant or lactating or intends to become pregnant during study period. Apparent moderate or severe acute illness. Clinical history of bleeding disorder such as hemophilia, thrombocytopenia, or anticoagulant therapy. Clinical history of impaired immune responsiveness, whether due to use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes. Hypersensitivity to the active substances or to any of the excipients of the HPV vaccine, or such reactions to other vaccines received in the past. Investigational drug or investigational vaccine administered during the period from 30 days before to 30 days after any dose of HPV vaccine.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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Female

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0,2,6 month vaccination schedule<br> | Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine<br>* Three doses of quadrivalent HPV recombinant vaccine administered at different dosing intervals in each of four study arms.<br>|
| Active Comparator: 0,3,9 month vaccination schedule<br> | Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine<br>* Three doses of quadrivalent HPV recombinant vaccine administered at different dosing intervals in each of four study arms.<br>|
| Active Comparator: 0,6,12 month vaccination schedule<br> | Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine<br>* Three doses of quadrivalent HPV recombinant vaccine administered at different dosing intervals in each of four study arms.<br>|
| Active Comparator: 0,12,24 month vaccination schedule<br> | Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine<br>* Three doses of quadrivalent HPV recombinant vaccine administered at different dosing intervals in each of four study arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. |  | 25 months | 
| Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. |  | 25 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. |  | 25 months | 
| Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. |  | 25 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gardasil, Human Papillomavirus, HPV vaccine, Cervical cancer