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

NCT02576054 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2019-11-25

Study results available
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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.

Conditions

  • Anogenital Human Papilloma Virus Infection
  • Condyloma Acuminata

Interventions

BIOLOGICAL

V501

Quadrivalent HPV \[Type 6, 11, 16 and 18\] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
15 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-20
Primary Completion
2018-08-08
Completion
2018-08-08

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02576054 on ClinicalTrials.gov