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

PHASE3CompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

June 12, 2018

Primary Completion Date

September 20, 2018

Study Completion Date

December 11, 2018

Conditions
Poliomyelitis
Interventions
BIOLOGICAL

sIPV-sIPV-bOPV vaccination schedule

Two intramuscular injections of the investigational vaccine (0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Biotech Co., Ltd . The poliovirus (Live) vaccine type I \& type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.

BIOLOGICAL

wIPV-wIPV-bOPV vaccination schedule

Two intramuscular injections of the control vaccine(0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I \& type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.

Trial Locations (1)

221300

Pizhou Center for Disease Control and Prevention, Xuzhou

All Listed Sponsors
lead

Sinovac Biotech Co., Ltd

INDUSTRY

NCT03822767 - "A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a 2+1Sequential Schedule With bOPV in Infants" | Biotech Hunter | Biotech Hunter