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

Cervical Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544478
• Other study ID #: V501-110
• Secondary ID: 1322472015-00293
• Status: Completed
• Phase: Phase 4
• Start date: November 25, 2011
• Est. completion date: August 27, 2016

Study information

• Verified date: November 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1030
• Est. completion date: August 27, 2016
• Est. primary completion date: August 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 26 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma in Situ
• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Neoplasms

Intervention

Biological:
• V501
HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Month 48