Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)

Study Overview
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Brief Summary
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Primary objective: • To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL. Secondary objectives: To evaluate the tolerability of V503 in 9-15 year-old girls. To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.

Official Title
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A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus (HPV) Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-old)

Conditions
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Human Papillomavirus

Intervention / Treatment
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* Biological: V503
* Biological: GARDASIL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female from 9 to 15 years old. Good physical health. Exclusion Criteria: Known allergy to any vaccine component. History of severe allergic reaction. Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. Pregnant subject. Immunocompromised or immunodeficient subject. Splenectomy. Receipt of medication / vaccine that may interfere with study assessment. Fever History of a positive test for HPV, prior receipt of HPV vaccine or prior participation to HPV trial. Any condition that might interfere with study assessment.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 15 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V503<br>9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 | Biological: V503<br>* 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine<br>* Other names: 9vHPV vaccine;|
| Active Comparator: GARDASIL<br>Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6 | Biological: GARDASIL<br>* Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine<br>* Other names: qHPV vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers (GMTs) to HPV Types 16 and 18 | Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay. | 4 weeks postdose 3 (Month 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMTs to HPV Types 6 and 11 | Serum antibodies to HPV types 6 and 11 were measured with a Competitive Luminex Immunoassay. | 4 weeks postdose 3 (Month 7) | 
| Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18 | Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck Units/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24. The percentage of participants who were seropositive according to these cutoffs was assessed. | 4 weeks postdose 3 (Month 7) | 
| Percentage of Participants With One or More Adverse Events | An adverse event is defined as any unfavourable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. The percentage of participants with one or more adverse events was assessed. | Up to Month 7 | 
| Percentage of Participants With One or More Injection-site Adverse Reactions | The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed. | Up to 5 days after any vaccination | 
| Percentage of Participants With One or More Systemic Adverse Events | The percentage of participants with one or more systemic adverse events was assessed. | Up to 15 days after any vaccination | 
| Percentage of Participants With Maximum Oral Temperature ≥37.8°C | The percentage of participants with maximum oral temperature ≥37.8°C was assessed. | Up to 15 days after any vaccination | 
| Percentage of Participants With One or More Serious Adverse Events | A serious adverse event is an adverse event that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse events was assessed. | Up to Month 7 |