A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).

Study Overview
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Brief Summary
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This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV) strains contained in the vaccine. The success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 HPV types.

Official Title
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A Phase III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese Preadolescent and Adolescent Girls

Conditions
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Papillomavirus Infections

Intervention / Treatment
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* Biological: V503


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is in good physical health- Participant's parent/legal guardian is able to read, understand, and complete the vaccine report card Participant's parent/legal guardian agrees to provide a phone number for follow-up purposes Participant is not sexually active and does not plan to become sexually active during the time from Day 1 to Month 7 of the study Exclusion Criteria: Participant has a history of severe allergic reaction that required medical intervention Participant has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection Participant is pregnant Participant intends to donate blood during the time from Day 1 to Month 7 of the study Participant is immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition. Participant has had a splenectomy Participant has received any of the following immunosuppressive therapies in the year prior to enrollment: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies, antilymphocyte sera, or other therapy known to interfere with the immune response. Participant has received any immune globulin product or blood-derived product in the three months prior to the Day 1 vaccination, or plans to receive any such product through Month 7 of the study Participant has received any inactivated vaccines within 14 days of the Day 1 vaccination or any live vaccines within 28 days of the Day 1 vaccination Participant has received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial Participant has had a fever (oral temperature ≥37.8°C) within 24 hours of the Day 1 vaccination Participant has a history of a positive test for HPV or history of genital warts

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Enrolled<br>9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. | Biological: V503<br>* V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine | Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8. | 4 weeks post-vaccination 3 (Month 7) | 
| Percentage of Participants With an Injection-site Adverse Event (AE) | An AE is defined as any unfavorable 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 vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded. | up to 5 days after any vaccination | 
| Percentage of Participants With a Non-Injection Site (Systemic) AE | An AE is defined as any unfavorable 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 vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs. | up to 15 days after any vaccination | 
| Percentage of Participants With a Vaccine-related AE | An AE is defined as any unfavorable 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 vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be definitely related, probably related, or possibly related to the study drug is defined as a vaccine-related AE. | up to 15 days after any vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine | Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL. | 4 weeks post-vaccination 3 (Month 7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Papillomavirus vaccines, Uterine cervical cancer, Human Papilloma Virus infections