Clinical trial NCT02576054: Safety and Tolerability Study of V501 in Japanese Boys (V501-200)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anogenital Human Papilloma Virus Infection
Condyloma Acuminata
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 101
Sex: MALE
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18
timeFrame: Four weeks postdose 3 (Month 7)
measure: Percentage of Participants With Elevated Oral Temperature (>=37.5° C)
timeFrame: Up to Day 5 after any vaccination
measure: Percentage of Participants With an Injection-site Adverse Event
timeFrame: Up to Day 5 after any vaccination
measure: Percentage of Participants With a Systemic Adverse Event
timeFrame: Up to Day 15 after any vaccination
measure: Percentage of Participants With a Serious Adverse Event
timeFrame: Up to Day 15 after any vaccination
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event
timeFrame: Up to 30 months
Secondary outcomes:
measure: 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
timeFrame: Four weeks postdose 3 (Month 7)
measure: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months
timeFrame: 12 months postdose 3 (18 months)
measure: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months
timeFrame: 24 months postdose 3 (30 months)
measure: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months
timeFrame: 12 months postdose 3 (18 months)
measure: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months
timeFrame: 24 months postdose 3 (30 months)
Other outcomes:
Locations:
city: Chiyoda-Ku, Tokyo
country: Japan
facility: MSD K.K.
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Murata S, Takeuchi Y, Yamanaka K, Hayakawa J, Yoshida M, Yokokawa R, Wakana A, Sawata M, Tanaka Y. Safety and Immunogenicity of the Quadrivalent HPV Vaccine in Japanese Boys: a Phase 3, Open-Label Study. Jpn J Infect Dis. 2019 Sep 19;72(5):299-305. doi: 10.7883/yoken.JJID.2018.448. Epub 2019 May 31.