Papillomavirus Infections MedDRA version: 20.0 Level: HLGT Classification code 10047438 Term: Viral infectious disorders System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level: LLT Classification code 10063001 Term: Human papilloma virus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: PT Classification code 10071146 Term: Human papilloma virus immunisation System Organ Class: 10042613 - Surgical and medical proced
Conditions
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? yes Number of subjects for this age range: 314 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To estimate percent seroconversion for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 in Japanese boys aged 9 to 15 years who received 3 doses of the 9vHPV vaccine - To estimate percent seroconversion for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 in Japanese boys aged 9 to 14 years who received 2 doses of the 9vHPV vaccine - To estimate percent seroconversion for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 in Japanese girls aged 9 to 14 years who received 2 doses of the 9vHPV vaccine - To evaluate the safety and tolerability of the 9vHPV vaccine in Japanese boys aged 9 to 15 years who received 3 doses and Japanese boys and girls aged 9 to 14 years who received 2 doses of the 9vHPV vaccine;Secondary Objective: - To estimate the immune response for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 including geometric mean titers (GMTs) in Japanese boys aged 9 to 15 years who received 3 doses of the 9vHPV vaccine - To estimate the immune response for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 including GMTs in Japanese boys aged 9 to 14 years who received 2 doses of the 9vHPV vaccine - To estimate the immune response for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 including GMTs in Japanese girls aged 9 to 14 years who received 2 doses of the 9vHPV vaccine;Primary end point(s): 1. Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 2. Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event 3. Percentage of Participants With at Least 1 Systemic Adverse Event 4. Percentage of Participants With at Least 1 Serious Adverse Event 5. Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event ;Timepoint(s) of evaluation of this end point: 1. 4 weeks post last vaccination (Month 7) 2. Up to 5 days post vaccinatio | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Geometric Mean Titers of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58;Timepoint(s) of evaluation of this end point: 1. 4 weeks post last vaccination (Month 7) | — |
Countries
Japan
Contacts
Public ContactShinya Murata
Merck Sharp & Dohme LLC
Outcome results
None listed