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ACTIVE NOT RECRUITING
NCT05662020
PHASE3

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

Sponsor: Beijing Health Guard Biotechnology, Inc

View on ClinicalTrials.gov

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.

Official title: A Parallel-controlled Study to Evaluate the Immunogenicity and Safety of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in Healthy Female Participants Aged 9-26 Years in China

Key Details

Gender

FEMALE

Age Range

9 Years - 26 Years

Study Type

INTERVENTIONAL

Enrollment

2750

Start Date

2022-03-23

Completion Date

2028-03-23

Last Updated

2022-12-27

Healthy Volunteers

Yes

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

Locations (1)

Yunnan Center for Disease Prevention and Control

Kunming, Yunnan, China