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

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.

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Key information

Conditions

Cervical Cancer Adenocarcinoma Adenocarcinoma in Situ Carcinoma Carcinoma in Situ Cervical Intraepithelial Neoplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Morphological and Microscopic Findings Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Signs and Symptoms Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

16 year–26 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

V501

Biological

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

Other names: Gardasil™

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Mar 6, 2012
Registry last updated: Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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