A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a '1+2' Sequential Schedule With bOPV in Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

June 6, 2018

Primary Completion Date

September 26, 2018

Study Completion Date

December 11, 2018

Conditions
Poliomyelitis
Interventions
BIOLOGICAL

sIPV-bOPV-bOPV vaccination schedule

Single intramuscular injection of the experimental sIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Vaccine Technology Co., Ltd. The poliovirus (Live) vaccine type I \& type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.

BIOLOGICAL

wIPV-bOPV-bOPV vaccination schedule

Single intramuscular injection of the control wIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively.The control wild strain inactivated poliovirus vaccine (wIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I \& type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.

Trial Locations (1)

222200

Guanyun Center for Disease Control and Prevention, Lianyungang

All Listed Sponsors
lead

Sinovac Biotech Co., Ltd

INDUSTRY

NCT03822754 - A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a '1+2' Sequential Schedule With bOPV in Infants | Biotech Hunter | Biotech Hunter