An Immunity Persistence Study of Sabin Inactivated Poliovirus Vaccine(Vero Cell) After Four Doses

Sinovac

Status: Completed

Conditions: Poliomyelitis

Treatments: Biological: Control IPV; Biological: Investigational sIPV

Study type: Observational

Funder types: Industry

Identifiers

NCT04989231

PRO-sIPV-3003

Details and patient eligibility

About

This is an open and observational follow-up clinical trial based on the previous Phase III clinical trial of Sabin Inactivated Poliovirus Vaccine manufactured by Sinovac Biotech Co. , the purpose of this study is to evaluate the immunity persistence of sIPV in infants after 4 doses of vaccination.

Full description

This study is an open and observational follow-up clinical trial based on the previous Phase III clinical trial of Sabin Inactivated Poliovirus Vaccine.The purpose of this study is to evaluate the immunity persistence of sIPV in infants after 4 doses of vaccination.A total of at least 450 subjects who have received 4 doses of the experimental vaccine or control vaccine will be enrolled,about 3.0ml of venous blood will be collected from each enrolled subject at the age of 4 years (48 to 54 months) and 5 years (78 to 84 months) after the last vaccination, respectively,and the serum will be separated for neutralizing antibody detection.The antibody levels of the experimental vaccine group and the control vaccine group will be compared to evaluate the immunity persistence of sIPV.

Enrollment: 450 patients

Sex: All

Ages: 48 to 84 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who have received 4 doses of experimental vaccine or control vaccine in phase Ⅲ clinical trials

Exclusion criteria

• History of vaccination of other vaccine with poliovirus antigenic components except that of phaseⅢ clinical trial.

Trial design

450 participants in 2 patient groups

Experimental Group

Description:

Subjects who have received 4 doses of the experimental vaccine (including subjects at the age of 4 years (48 to 54 months) and 5 years (78 to 84 months) after the last vaccination ) will be collected venous blood about 3.0ml.

Treatment:

Biological: Investigational sIPV

Control Group

Description:

Subjects who have received 4 doses of control vaccine (including subjects at the age of 4 years (48 to 54 months) and 5 years (78 to 84 months) after the last vaccination ) will be collected venous blood about 3.0ml.

Treatment:

Biological: Control IPV