A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 1,030
- Primary Endpoint
- Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 26 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
V501
Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
Intervention: V501 (Biological)
Outcomes
Primary Outcomes
Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported