Phase 3
Completed N=101
Safety and Tolerability Study of V501 in Japanese Boys (V501-200)
Anogenital Human Papilloma Virus Infection · Condyloma Acuminata
Source: ClinicalTrials.gov NCT02576054 ↗
Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18 — 94.9; 99.0; 99.0; 99.0 Percentage of Participants
◆ Published Evidence
Emerging
4citations · ~1 / year
Safety and Immunogenicity of the Quadrivalent HPV Vaccine in Japanese Boys: a Phase 3, Open-Label Study.
Summary
This is a study of V501 [quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine] in healthy Japanese boys. This study will consist of two periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when all subjects have completed their Month 7 visit or have been discontinued before that time. The second analysis will be conducted at the end of study. The primary hypothesis tested in this study is that seroconversion rates for the vaccine HPV types will be >90% at 4 weeks postdose 3.
Linked Publications
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Safety and Immunogenicity of the Quadrivalent HPV Vaccine in Japanese Boys: a Phase 3, Open-Label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18 |
94.9; 99.0; 99.0; 99.0 | — |
| PRIMARY Percentage of Participants With Elevated Oral Temperature (>=37.5° C) |
3.0; 1.0; 2.0 | — |
| PRIMARY Percentage of Participants With an Injection-site Adverse Event |
64.0 | — |
| PRIMARY Percentage of Participants With a Systemic Adverse Event |
21.0 | — |
| PRIMARY Percentage of Participants With a Serious Adverse Event |
0.0 | — |
| PRIMARY Percentage of Participants With a Vaccine-related Serious Adverse Event |
0.0 | — |
| SECONDARY Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18 Participants Aged 9 to 15 Years Versus Participants Aged 16 to 26 Years |
482.9; 385.0; 1052.8; 458.4; 3878.3; 2294.8 | <0.001 sig |
| SECONDARY Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months |
222.0; 259.9; 1154.1; 212.1 | — |
| SECONDARY Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months |
177.5; 181.5; 831.3; 144.2 | — |
| SECONDARY Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months |
97.9; 100.0; 99.0; 94.8 | — |
| SECONDARY Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months |
98.0; 98.0; 99.0; 93.9 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy Japanese male
- Have a legal representative who provides written informed consent for the trial on the participant's behalf
- Have a legal representative who is able to read, understand, and complete the vaccine report card
- Has not yet had coitarche and does not plan on becoming sexually active from Day 1 through Month 7 of the study
- Other inclusion criteria will be discussed with the investigator during screening
Exclusion Criteria
- Currently enrolled in clinical studies of investigational agents
- History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
- History of severe allergic reaction that required medical intervention
- Allergic to any vaccine component, including aluminum, yeast, or BENZONASE™
- Received immune globulin or blood-derived products in the past 6 months or plans to receive any before Month 7 of the study
- History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
- Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids
- Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
- Ongoing alcohol or drug abuse within the past 12 months
- History of genital warts or a positive test for HPV
Data sourced from ClinicalTrials.gov (NCT02576054) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.