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

NCT01544478 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: V501-1101322472015-002932-42
• Study Type: interventional
• Target: 1,030
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer; Cervical Intraepithelial Neoplasia; Adenocarcinoma in Situ

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

V501

EXPERIMENTAL

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

Biological: V501

Interventions

V501 BIOLOGICAL

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

Also known as: Gardasil™

V501

Eligibility Criteria

• Age: 16 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Sakamoto M, Miyagi E, Sumi Y, Aisaka K, Kuno N, Nagano H, Asahara S, Han SR, Wakana A, Murata S, Sawata M, Tanaka Y. Effectiveness on high-grade cervical abnormalities and long-term safety of the quadrivalent human papillomavirus vaccine in Japanese women. J Infect Chemother. 2019 Jul;25(7):520-525. doi: 10.1016/j.jiac.2019.02.012. Epub 2019 Mar 15.

  PMID: 30879979 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Adenocarcinoma in Situ

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 6, 2012
• Study Start: November 25, 2011
• Primary Completion: August 27, 2016
• Study Completion: August 27, 2016
• Last Updated: November 28, 2018
• Results First Posted: July 7, 2017

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share