Safety and Tolerability Study of V501 in Japanese Boys (V501-200)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-20

Study Completion Date

2018-08-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Anogenital Human Papilloma Virus Infection Condyloma Acuminata

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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V501

0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Group Type EXPERIMENTAL

V501

Intervention Type BIOLOGICAL

Quadrivalent HPV \[Type 6, 11, 16 and 18\] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Interventions

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V501

Quadrivalent HPV \[Type 6, 11, 16 and 18\] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Intervention Type BIOLOGICAL

Other Intervention Names

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Gardasil™

Eligibility Criteria

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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

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

Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes