NCT05680454View on ClinicalTrials.gov

A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine

PHASE1CompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

September 1, 2019

Primary Completion Date

April 6, 2020

Study Completion Date

May 10, 2022

Conditions
Human Papillomavirus Infection
Interventions
BIOLOGICAL

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

For Low-dosage group, a 3-dose regimen administered at months 0, 2 and 6. For Mid-dosage group, a 3-dose regimen administered at months 0, 2 and 6. For High-dosage group, a 3-dose regimen administered at months 0, 2 and 6.

BIOLOGICAL

Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine

A 3-dose regimen administered at months 0, 2 and 6.

Trial Locations (1)

210009

CDC, Jiangsu Province, Nanjing

Sponsors
All Listed Sponsors
collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

collaborator

National Institutes for Food and Drug Control, China

OTHER

collaborator

Nanjing Sangruisi Pharmaceutical Technology Co., Ltd

UNKNOWN

collaborator

School of Public Health of Southeastern University

UNKNOWN

lead

Beijing Health Guard Biotechnology, Inc

INDUSTRY