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A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy Females

NCT05584332 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3131

Last updated 2023-07-21

No results posted yet for this study

Summary

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 18-45 Years .

Conditions

  • Cervical Cancer
  • Genital Wart
  • CIN1
  • CIN2
  • CIN3
  • Vain I
  • Vain III
  • Vin I
  • Vin II
  • Vin III
  • AIS
  • VAIN - Vaginal Intraepithelial Neoplasia 2

Interventions

BIOLOGICAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha)

0.5 ml injection in 3 dosing regimen

BIOLOGICAL

Placebo

0.5 ml injection in 3 dosing regimen

Sponsors & Collaborators

  • Shanghai Bovax Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-12-09
Primary Completion
2023-03-23
Completion
2023-03-23

Countries

  • China

Study Locations

More Related Trials

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 NCT05584332 on ClinicalTrials.gov