Overview

This trial is active, not recruiting.

Conditions anogenital human papilloma virus infection, condyloma acuminata
Treatment v501
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date November 2015
End date September 2018
Trial size 100 participants
Trial identifier NCT02576054, V501-200

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
v501
V501 (GARDASIL™, Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Primary Outcomes

Measure
Percentage of Participants with Seroconversion for HPV Types 6, 11, 16, and 18
time frame: Four weeks postdose 3 (7 weeks)
Percentage of Participants with Elevated Oral Temperature (>=37.5° C)
time frame: Up to Day 5 after any vaccination
Percentage of Participants with an Injection-site Adverse Event
time frame: Up to Day 5 after any vaccination
Percentage of Participants with a Systemic Adverse Event
time frame: Up to Day 15 after any vaccination
Percentage of Participants with a Serious Adverse Event
time frame: Up to Day 15 after any vaccination
Percentage of Participants with a Vaccine-related Serious Adverse Event
time frame: Up to 30 months

Secondary Outcomes

Measure
Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18
time frame: Four weeks postdose 3 (7 weeks)
Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months
time frame: 12 months postdose 3 (18 months)
Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months
time frame: 24 months postdose 3 (30 months)
Percentage of Participants with Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months
time frame: 12 months postdose 3 (18 months)
Percentage of Participants with Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months
time frame: 24 months postdose 3 (30 months)

Eligibility Criteria

Male participants from 9 years up to 15 years old.

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

Additional Information

Official title A Phase III, Open-Label, Clinical Trial to Study the Safety and Immunogenicity of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Particle (VLP) Vaccine in 9- to 15-Year-Old Japanese Boys
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..