Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

NCT04425291 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1680

Last updated 2022-02-25

No results posted yet for this study

Summary

The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age.

Conditions

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

Interventions

BIOLOGICAL

4-valent HPV Vaccine

Subjects received 3 doses of 4-valent HPV vaccine according to a 0, 2, 6-month schedule.

BIOLOGICAL

9-valent HPV Vaccine

Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.

BIOLOGICAL

GARDASIL®

Subjects received 3 doses of GARDASIL® according to a 0, 2, 6-month schedule.

Sponsors & Collaborators

  • Chongqing Bovax Biopharmaceutical Co., Ltd.

    collaborator INDUSTRY
  • 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
2020-05-28
Primary Completion
2021-09-06
Completion
2021-09-06

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04425291 on ClinicalTrials.gov