A Long Term Safety and Effectiveness Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)

• Conditions: HPV; MedDRA version: 18.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-005717-23-Outside-EU/EEA
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-18
• Last Update Posted: 28 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1575

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified