Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Papillomavirus Infections

Treatments: Biological: 9vHPV vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04772534

2020-001170-29 (EudraCT Number)

jRCT2031210080 (Registry Identifier)

V503-066 (Other Identifier)

Details and patient eligibility

About

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 9vHPV vaccine. No hypothesis will be tested since this study is an estimation-only study.

Enrollment: 312 patients

Sex: All

Ages: 9 to 15 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

312 participants in 3 patient groups

3-dose in 9 to 15 year old boys

Experimental group

Description:

9 to 15 year old boys will receive a 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine (Day 1, Month 2 and Month 6).

Treatment:

Biological: 9vHPV vaccine

2-dose in 9 to 14 year old boys

Experimental group

Description:

9 to 14 year old boys receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).

Treatment:

Biological: 9vHPV vaccine

2-dose in 9 to 14 year old girls

Experimental group

Description:

9 to 14 year old girls receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).

Treatment:

Biological: 9vHPV vaccine