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

Merck Sharp & Dohme LLC1,030 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

1,030

Conditions

Cervical Cancer Cervical Intraepithelial Neoplasia Adenocarcinoma in Situ

Interventions

V501BIOLOGICAL

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

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 26 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

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

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.

Time frame: Up to Month 48

Data from ClinicalTrials.gov

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