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

NCT ID: NCT01544478

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1030 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-25
• Study Completion Date: 2016-08-27

Brief Summary

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.

Conditions

Cervical Cancer; Cervical Intraepithelial Neoplasia; Adenocarcinoma in Situ

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

V501

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

Group Type: EXPERIMENTAL

V501

Intervention Type: BIOLOGICAL

HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6

Interventions

V501

HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6

Intervention Type: BIOLOGICAL

Other Intervention Names

Gardasil™

Eligibility Criteria

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Sakamoto M, Miyagi E, Sumi Y, Aisaka K, Kuno N, Nagano H, Asahara S, Han SR, Wakana A, Murata S, Sawata M, Tanaka Y. Effectiveness on high-grade cervical abnormalities and long-term safety of the quadrivalent human papillomavirus vaccine in Japanese women. J Infect Chemother. 2019 Jul;25(7):520-525. doi: 10.1016/j.jiac.2019.02.012. Epub 2019 Mar 15.

Reference Type: DERIVED

PMID: 30879979 (View on PubMed)

Other Identifiers

132247

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-002932-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V501-110

Identifier Type: -

Identifier Source: org_study_id