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A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males

NCT06866574 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9300

Last updated 2025-07-31

No results posted yet for this study

Summary

This phase III clinical trial was designed to evaluate the efficacy, immunogenicity and safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in Chinese males aged 18-45 years.

Conditions

  • Penile/Perineal /Perianal Intraepithelial Neoplasia
  • Anal Intraepithelial Neoplasia
  • Penile/Perianal/Perineal Cancer
  • Anal Cancer
  • Genital Warts

Interventions

BIOLOGICAL

Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli)

Participants received 3 doses of 9-valent HPV vaccine according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle of the upper arm)

BIOLOGICAL

Aluminum Adjuvant

Participants received 3 doses of Aluminum Adjuvant according to a 0, 1, 6-month schedule (0.5 mL intramuscular injection in the deltoid muscle the upper arm).

Sponsors & Collaborators

  • Xiamen Innovax Biotech Co., Ltd

    collaborator INDUSTRY

  • Xiamen University

    lead OTHER

Principal Investigators

  • Jun Zhang, Master · Xiamen University

  • Xiaoqiang Liu, Ph.D. · Yunnan Provincial Center for Disease Control and Prevention

  • Long Sui, Ph.D. · Obstetrics & Gynecology Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-04-11
Primary Completion
2031-09-30
Completion
2031-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT06866574 on ClinicalTrials.gov