EUCTR2020-001170-29-Outside-EU/EEA
Active, not recruiting
Phase 1
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.
ConditionsPapillomavirus InfectionsMedDRA version: 20.0Level: HLGTClassification code 10047438Term: Viral infectious disordersSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 21.1Level: PTClassification code 10071146Term: Human papilloma virus immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Immune system processes [G12]
DrugsGARDASIL®9
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Papillomavirus Infections
- Sponsor
- Merck Sharp & Dohme LLC
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
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
- •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
- •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).
Outcomes
Primary Outcomes
Not specified
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