V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Adenocarcinoma in Situ; Cervical Intraepithelial Neoplasia; Cervical Cancer

Treatments: Biological: V501

Study type: Interventional

Funder types: Industry

Identifiers

NCT01544478

132247 (Registry Identifier)

V501-110

2015-002932-42 (EudraCT Number)

Details and patient eligibility

About

This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.

Enrollment: 1,030 patients

Sex: Female

Ages: 16 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese females
• Not pregnant at Screening and agree to use effective contraception through Month 7 of the study
• Lifetime history of 0 to 4 male or female sexual partners
• No oral temperature ≥37.5 centigrade within 24 hours prior to injection

Exclusion criteria

• Received a marketed HPV vaccine
• Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN
• Known history of positive test for HPV
• Known history of genital warts
• Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study
• History of splenectomy, known immune disorders, or receiving immunosuppressives
• Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,030 participants in 1 patient group

V501

Experimental group

Description:

Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6

Treatment:

Biological: V501