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A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China

NCT05662020 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2750

Last updated 2022-12-27

No results posted yet for this study

Summary

The study is to evaluate immune response induced by 9-valent HPV study vaccine is non-inferior to those induced by GARDASIL® 9 administrated with 3-dose schedule in female participants aged 20-26 years in China, if the immune response induced with same conditions in 9-19 age group is non-inferior to 20-26 age group, and if the immune response induced by 9-valent HPV study vaccine administrated with 2-dose schedule in females aged 9-14 years is non-inferior to 3-dose schedule in females aged 20-26 years.

Conditions

  • Human Papillomavirus Infection

Interventions

BIOLOGICAL

Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)

9-19 years group (3 doses) and 20-26 years group (3 doses) will be vaccinated at months 0, 2, 6. 9-14 years group (2 doses) will be vaccinated at months 0, 6.

BIOLOGICAL

GARDASIL® 9

20-26 years possitive control group will be vaccinated at months 0, 2 and 6

Sponsors & Collaborators

  • Yunnan Center for Disease Control and Prevention

    collaborator OTHER

  • Mile City Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Qiubei County Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Yanshan County Center for Disease Control and Prevention

    collaborator UNKNOWN

  • National Institutes for Food and Drug Control, China

    collaborator OTHER

  • Shanghai Stem Pharmaceutical Development Co., Ltd.

    collaborator UNKNOWN

  • Beijing Health Guard Biotechnology, Inc

    lead INDUSTRY

Principal Investigators

  • Yongjiang Liu, Bachelor · Beijing Health Guard Biotechnology, Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-23
Primary Completion
2022-11-07
Completion
2028-03-23

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 NCT05662020 on ClinicalTrials.gov