EUCTR2009-011617-25-Outside-EU/EEA
Active, not recruiting
Phase 1
A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 year olds) with a Comparison to Young Women (16 to 26 year olds)
ConditionsCervical CancersVulvar CancerVaginal CancerGenital LesionsPAP Test AbnormalitiesHPV InfectionsMedDRA version: 20.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsGardasil 9
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cervical CancersVulvar CancerVaginal CancerGenital LesionsPAP Test AbnormalitiesHPV Infections
- Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Boys and Girls Age 9 to 15 Years:
- •1\. Subject is male or female, between the ages of 9 years and 0 days and 15 years and 364 days on the day of enrollment.
- •2\. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
- •3\. Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
- •4\. Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow\-up purposes.
- •5\. Subject must not yet have had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7 period.
- •Inclusion Criteria: Women Age 16 to 26 Years:
- •6\. Subject is female, between the ages of 16 years and 0 days and 26 years and 364 days on the day of enrollment.
- •7\. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
- •8\. Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
Exclusion Criteria
- •Exclusion Criteria: Boys and Girls Age 9 to 15 Years
- •1\. Subject has a known allergy to any vaccine component.
- •2\. Subject has a history of severe allergic reaction that required medical intervention.
- •3\. Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- •4\. Subject is concurrently enrolled in clinical studies of investigational agents.
- •5\. (Girls only) \- Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL ß\-hCG).
- •6\. Subject has donated blood within 1 week prior to the Day 1 vaccination, or intends to donate during Day 1 through Month 7 of the study.
- •7\. Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoidarthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
- •8\. Subject has had a splenectomy.
- •9\. Subject is receiving or has received in the year prior to enrollment immunosuppressive therapies prohibited by the protocol
Outcomes
Primary Outcomes
Not specified
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