EUCTR2014-005717-23-Outside-EU/EEA
Active, not recruiting
Not Applicable
A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL™ (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL™ at 9-18 Years of Age - A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites1,575 target enrollmentDecember 18, 2015
ConditionsHPVMedDRA version: 18.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsGardasil TM
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HPV
- Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
- Enrollment
- 1575
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adolescents and preadolescents (9 Years to 15 Years Old) with no prior sexual history
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 801
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 289
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Subjects with compromised immune system or have a history of severe allergic reaction
Outcomes
Primary Outcomes
Not specified
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