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

Poliomyelitis Clinical Trial

Official title:

An Open and Observational Phase Ⅳ Clinical Trial to Evaluate the Immunity Persistence of Sabin Inactivated Poliovirus Vaccine (Vero Cell) After Four Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04989231
• Other study ID #: PRO-sIPV-3003
• Status: Completed
• Start date: September 9, 2021
• Est. completion date: December 25, 2022

Study information

• Verified date: October 2021
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 25, 2022
• Est. primary completion date: December 25, 2022
• Gender: All
• Age group: 48 Months to 84 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• Investigational sIPV
Three intramuscular injections of the investigational vaccine (0.5 ml) at 0 month ,1 month and 2 months respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months
• Control IPV
Three intramuscular injections of the control vaccine (0.5 ml) at 0 month ,1 month and 2 months respectively;Single intramuscular injection of the control vaccine (0.5ml) at 18 months

Locations

Country	Name	City	State
China	Pizhou county Center for Disease Control and Prevention	Pizhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All of participants with seroconversion rates of the neutralizing antibody of each group at the observation point wich at the age of 4 years (48 to 54 months) will be assessed	About 3.0ml of venous blood will be collected from all of the subjects at the age of 4 years (48 to 54 months) and all of the participants with seroconversion rates of the neutralizing antibody at the observation point wich at the age of 4 years (48 to 54 months) will be compared to evaluate the immunity persistence of SIPV.	At the age of 4 years (48 to 54 months) after the vaccination of the experimental vaccine or control vaccine
Primary	All of participants with seroconversion rates of the neutralizing antibody of each group at the observation point wich in 5 years (78 to 84 months) after the last vaccination will be assessed	About 3.0ml of venous blood will be collected from all of the subjects in 5 years (78 to 84 months) after the last vaccination and all of the participants with seroconversion rates of the neutralizing antibody at the observation point which in 5 years (78 to 84 months) after the last vaccination will be compared to evaluate the immunity persistence of SIPV.	In 5 years (78 to 84 months) after the last vaccination of the experimental vaccine or control vaccine
Secondary	All of participants with geometric mean titer (GMT) of each group at the observation point wich at the age of 4 years (48 to 54 months) will be assessed	All of participants with geometric mean titer (GMT) in experimental group and control group at the observation point wich at the age of 4 years (48 to 54 months) will be compared to evaluate the immunity persistence of SIPV.	At the age of 4 years (48 to 54 months)
Secondary	All of participants with geometric mean titer (GMT) of each group at the observation point wich in 5 years (78 to 84 months) after the last vaccination will be assessed	All of participants with geometric mean titer (GMT) in experimental group and control group at the observation point wich in 5 years (78 to 84 months) after the last vaccination of the experimental vaccine or control vaccine will be compared to evaluate the immunity persistence of SIPV.	In 5 years (78 to 84 months) after the last vaccination of the experimental vaccine or control vaccine