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Immunogenicity and Safety of Quadrivalent HPV Vaccine in Healthy Chinese Female Subjects Aged 9 to 19 Years

NCT05027776 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1348

Last updated 2024-04-17

No results posted yet for this study

Summary

This phase 3 study will evaluate the immunogenicity and safety of Quadrivalent HPV recombinant vaccine in Chinese females aged 9 to 26 years

Conditions

  • HPV Infections
  • Cervical Cancer Stage IIa
  • Vaginal Cancer
  • Genital Wart
  • CIN1
  • CIN2
  • CIN3

Interventions

BIOLOGICAL

2-doses Group among 9-14 years

Subjects were planned to receive two doses of the study vaccine administered intramuscularly according to a 0, 6 month vaccination schedule.

BIOLOGICAL

3-doses Group among 9-19 years

Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.

BIOLOGICAL

3-doses Group among 20-26 years

Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.

Sponsors & Collaborators

  • Chongqing Bovax Biopharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Shanghai Bovax Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ting Huang · Sichuan Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
26 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2023-11-22
Completion
2026-09-29

Countries

  • China

Study Locations

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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 NCT05027776 on ClinicalTrials.gov