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

Phase 4

Completed

• Conditions: Cervical Cancer; Adenocarcinoma in Situ; Cervical Intraepithelial Neoplasia
• Interventions: Biological: V501

• Registration Number: NCT01544478
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-25
• Study First Submitted: 2012-02-29
• Study First Submitted QC: 2012-02-29
• Study First Posted: 2012-03-06
• Primary Completion: 2016-08-27
• Study Completion: 2016-08-27
• Results First Submitted: 2017-06-08
• Results First Submitted QC: 2017-06-08
• Results First Posted: 2017-07-07
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1030

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18	Up to Month 48	The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution.