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

NCT05372016 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2023-11-24

No results posted yet for this study

Summary

The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.

Conditions

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

Interventions

BIOLOGICAL

Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)

9vHPV vaccine ,0.5mL, three doses, 0,2,6 months

BIOLOGICAL

Active Comparator: GARDASIL ®9

GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months

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
16 Years
Max Age
26 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-19
Primary Completion
2022-06-17
Completion
2022-06-17

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 NCT05372016 on ClinicalTrials.gov