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Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

NCT04422366 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8000

Last updated 2024-06-07

No results posted yet for this study

Summary

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years .

Conditions

  • Cervical Cancer
  • Vulvar Cancer
  • Vaginal Cancer
  • CIN1
  • CIN2
  • CIN3
  • VaIN1
  • VaIN2
  • VaIN3
  • Genital Wart
  • VIN 1
  • VIN 2
  • VIN 3
  • AIS

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.

BIOLOGICAL

GARDASIL®

Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule

Sponsors & Collaborators

  • Shanghai Bovax Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2027-09-15
Completion
2029-09-15

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 NCT04422366 on ClinicalTrials.gov