Immunogenicity, Tolerability, and Manufacturing Consistency study of a Multivalent HPV, VLP vaccine

Phase 1

• Conditions: Prevention of cervical, vulvar, and vaginal cancers and related precancers, externalgenital lesions, Pap test abnormalities, and persistent infection caused by humanpapillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.; MedDRA version: 20.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2009-011617-25-BE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-14
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Subjects who are concurrently enrolled in clinical studies that would involve or interfere with the collection of genital specimens.

Study & Design

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