EUCTR2009-011617-25-PL
Active, not recruiting
Phase 1
A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, andManufacturing Consistency of a Multivalent Human Papillomavirus (HPV)L1 Virus-Like Particle (VLP) Vaccine Administered in Preadolescents andAdolescents (9 to 15 year olds), with a Comparison to Young Women (16 to26 year olds). - Immunogenicity, Tolerability, and Manufacturing Consistency study of a Multivalent HPV, VLP vaccine.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites3,123 target enrollmentSeptember 25, 2009
ConditionsPrevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, Pap test abnormalities, and persistent infection caused by human papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.MedDRA version: 20.0Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862Therapeutic area: Body processes [G] - Immune system processes [G12]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, Pap test abnormalities, and persistent infection caused by human papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
- Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
- Enrollment
- 3123
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject was enrolled in Protocol 002 between 9 and 15 years of age and
- •received 3 doses of 9\-valent HPV L1 VLP vaccine.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4022
- •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
- •Subjects who are concurrently enrolled in clinical studies that would
- •involve or interfere with the collection of genital specimens.
Outcomes
Primary Outcomes
Not specified
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Not Applicable
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