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A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males

NCT06465914 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9000

Last updated 2024-12-12

No results posted yet for this study

Summary

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Human Papillomavirus (HPV) Recombinant Vaccine (Hansenula Polymorpha) in Chinese male subjects aged 18-45 years. The primary hypothesis in the study is the 9-valent HPV recombinant vaccine reduces the incidence of vaccine HPV types-related genital warts compared with placebo in Chinese men.

Conditions

  • Genital Wart
  • Penile Cancer
  • Anal Cancer
  • PIN-1
  • PIN2
  • PIN3
  • AIN1
  • AIN2
  • AIN3
  • HPV-Related Carcinoma

Interventions

BIOLOGICAL

9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha)

Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle).

BIOLOGICAL

Placebo

Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle).

Sponsors & Collaborators

  • Shanghai Bovax Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lidong Gao, Master · Hunan Provincial Center for Disease Control and Prevention

  • Long Sui, Doctor · Obstetrics & Gynecology Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2027-07-30
Completion
2030-07-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT06465914 on ClinicalTrials.gov