Clinical Trial: Safety and Tolerability Study of V501 in Japanese Boys (V501-200)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase III, Open-Label, Clinical Trial to Study the Safety and Immunogenicity of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Particle (VLP) Vaccine in 9- to 15-Year-Old Japanese Boys

Brief Summary: This is a study of V501 [quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1 Virus-Like Particle (VLP) vaccine] in healthy Japanese boys. This study will consist of two periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when all subjects have completed their Month 7 visit or have been discontinued before that time. The second analysis will be conducted at the end of study. The primary hypothesis tested in this study is that seroconversion rates for the vaccine HPV types will be >90% at 4 weeks postdose 3.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Percentage of Participants with Seroconversion for HPV Types 6, 11, 16, and 18 [ Time Frame: Four weeks postdose 3 (7 weeks) ]
  • Percentage of Participants with Elevated Oral Temperature (>=37.5° C) [ Time Frame: Up to Day 5 after any vaccination ]
  • Percentage of Participants with an Injection-site Adverse Event [ Time Frame: Up to Day 5 after any vaccination ]
  • Percentage of Participants with a Systemic Adverse Event [ Time Frame: Up to Day 15 after any vaccination ]
  • Percentage of Participants with a Serious Adverse Event [ Time Frame: Up to Day 15 after any vaccination ]
  • Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to 30 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18 [ Time Frame: Four weeks postdose 3 (7 weeks) ]
  • Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months [ Time Frame: 12 months postdose 3 (18 months) ]
  • Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months [ Time Frame: 24 months postdose 3 (30 months) ]
  • Percentage of Participants with Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months [ Time Frame: 12 months postdose 3 (18 months) ]
  • Percentage of Participants with Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months [ Time Frame: 24 months postdose 3 (30 months) ]


Original Secondary Outcome: Same as current

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: October 13, 2015
Date Started: November 20, 2015
Date Completion: September 7, 2018
Last Updated: May 12, 2017
Last Verified: May 2017