A Phase III Trial Evaluates the Efficacy, Immunogenicity and Safety Profile of HPV Vaccine

PHASE3UnknownINTERVENTIONAL
Enrollment

12,000

Participants

Timeline

Start Date

December 5, 2020

Primary Completion Date

July 21, 2022

Study Completion Date

February 23, 2023

Conditions
Human Papillomavirus Infection
Interventions
BIOLOGICAL

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

0.5-mL suspension for injection, each 0.5-mL prefilled syringe dose contains L1 proteins of HPV types 6/11/16/18/31/33/45/52/58 in the amounts of 30mcg, 40mcg, 60mcg, 40mcg, 20mcg, 20mcg, 20mcg, 20mcg and 20mcg, respectively, totaling 270mcg of antigens. A 3-dose regimen administered at months 0, 2 and 6.

BIOLOGICAL

Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)(GARDASIL®)

0.5-mL suspension for injection, each 0.5-mL single-dose syringe contains approximately 20 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 40 mcg of HPV Type 16 L1 protein, 20 mcg of HPV Type 18 L1 protein, totaling 120 mcg of antigens

Trial Locations (3)

210009

CDC, Jiangsu Province, Nanjing

510440

CDC, Guangdong Provinc, Guangzhou

030012

CDC, Shanxi Province, Taiyuan

All Listed Sponsors
lead

Beijing Health Guard Biotechnology, Inc

INDUSTRY