Clinical trial NCT04772534: Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)
Official title: A Phase 3, Open-label Clinical Study to Evaluate the Immunogenicity and Safety of 9vHPV Vaccine, in Japanese Boys and Girls, 9 to 15 Years of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papillomavirus Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 314
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9-valent human papillomavirus (9vHPV) vaccine. No hypothesis will be tested since this study is an estimation-only study.


Eligibility criteria: Inclusion Criteria:

* Is Japanese male or female.
* Is aged at the time of providing the documented informed consent (inclusive): (3-dose boy arm) male from 9 years to 15 years old, (2-dose boy arm) male from 9 years to 14 years old, or (2-dose girl arm) female from 9 years to 14 years old.
* Has a legally acceptable representative who can read, understand and complete the vaccination report card (VRC).
* Has not yet had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7.

Exclusion Criteria:

* Has a fever (defined as oral temperature ≥37.5°C) within the 24-hour period prior to the Day 1 visit.
* Has a history of severe allergic reaction that required medical intervention.
* Is allergic to any vaccine component, including aluminum, yeast, or Benzonase™.
* Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
* Is currently 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 auto immune condition.
* Has a history of splenectomy.
* Has a history of genital warts or positive test for human papillomavirus (HPV).
* Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within 12 months) of drug or alcohol abuse or dependence at the discretion of the investigator. .
* Has received within 12 months prior to enrollment, is receiving, or plans to receive during Day 1 through Month 7 of the study, any study-prohibited concomitant immunosuppressive therapy .
* Has received within the 3 months prior to the Day 1 vaccination, is receiving, or plans to receive during Day 1 through Month 7 of the study, any immune globulin product or blood-derived product other than intravenous gamma globulin (IVIG).
* Has received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vaccines within 28 days prior to Day 1 vaccination.
* Has previously received a marketed HPV vaccine or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo).
* Is concurrently enrolled in other clinical studies of investigational agents.
* Is unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled.
* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Primary outcomes:
measure: Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
timeFrame: 1 month after final dose (Month 7)
measure: Number of Participants With at Least 1 Injection-site Adverse Event (AE)
timeFrame: Up to 5 days after each vaccination (up to ~6 months)
measure: Number of Participants With at Least 1 Systemic Adverse Event
timeFrame: Up to 15 days after each vaccination (up to ~6.5 months)
measure: Number of Participants With at Least 1 Serious Adverse Event (SAE)
timeFrame: Up to ~Month 30
Secondary outcomes:
measure: Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
timeFrame: 1 month after final dose (Month 7)
Other outcomes:
Locations:
city: Isumi-shi
country: Japan
facility: Sotobo Children's Clinic ( Site 6616)
state: Chiba
city: Sapporo
country: Japan
facility: Ohigesenseino Kodomo Clinic ( Site 6607)
state: Hokkaido
city: Sapporo
country: Japan
facility: Motomachi Pediatric Clinic ( Site 6606)
state: Hokkaido
city: Sakai
country: Japan
facility: Medical Corporation Bunmeikai Okuda E.N.T ( Site 6611)
state: Osaka
city: Fukui
country: Japan
facility: Fukui General Hospital ( Site 6614)
city: Osaka
country: Japan
facility: Nomura Clinic Namba ( Site 6608)
city: Osaka
country: Japan
facility: Medical Corporation Kanyukai Kikumori Otolaryngology Clinic ( Site 6612)
city: Tokyo
country: Japan
facility: Doujin Memorial Medical Foundation, Meiwa Hospital ( Site 6603)
city: Tokyo
country: Japan
facility: Okawa Children & Family Clinic ( Site 6610)
city: Tokyo
country: Japan
facility: Shinjuku Higashiguchi Clinic ( Site 6602)
city: Tokyo
country: Japan
facility: Hayashi Clinic ( Site 6615)
city: Tokyo
country: Japan
facility: Ogikuboekimae Clinic ( Site 6601)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: