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.
Overview
- Phase
- Phase 3
- Intervention
- 9vHPV vaccine
- Conditions
- Papillomavirus Infections
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 314
- Locations
- 12
- Primary Endpoint
- Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
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).
Arms & Interventions
3-dose in 9 to 15 year old boys
9 to 15 year old boys will receive a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6).
Intervention: 9vHPV vaccine
2-dose in 9 to 14 year old boys
9 to 14 year old boys receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
Intervention: 9vHPV vaccine
2-dose in 9 to 14 year old girls
9 to 14 year old girls receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6).
Intervention: 9vHPV vaccine
Outcomes
Primary Outcomes
Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Time Frame: 1 month after final dose (Month 7)
The percentage of seropositive participants is reported. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA). Seroconversion was defined as changing serostatus from seronegative at Day 1 to seropositive at 4 weeks post last vaccination.
Number of Participants With at Least 1 Injection-site Adverse Event (AE)
Time Frame: Up to 5 days after each vaccination (up to ~6 months)
The number of participants with injection-site AEs (erythema/redness, pain and swelling) is reported. An AE any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants With at Least 1 Systemic Adverse Event
Time Frame: Up to 15 days after each vaccination (up to ~6.5 months)
The number of participants with a systemic AE is reported. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants With at Least 1 Serious Adverse Event (SAE)
Time Frame: Up to ~Month 30
The number of participants with an SAE is reported. An SAE is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention.
Secondary Outcomes
- Geometric Mean Titers (GMTs) for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58(1 month after final dose (Month 7))