Clinical trial NCT04989231: An Immunity Persistence Study of Sabin Inactivated Poliovirus Vaccine(Vero Cell) After Four Doses
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Poliomyelitis
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 450
Sex: ALL
Minimum age (years): 48
Maximum age (years): 84
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of at least 450 subjects will be enrolled, subjects should meet the inclusion criteria :Subjects who have received 4 doses of experimental vaccine or control vaccine in phase Ⅲ clinical trials and subjects should not meet the exclusion criteria:history of vaccination of other vaccine with poliovirus antigenic components except that of phaseⅢ clinical trial.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: At the age of 4 years (48 to 54 months) after the vaccination of the experimental vaccine or control vaccine
measure: 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
timeFrame: In 5 years (78 to 84 months) after the last vaccination of the experimental vaccine or control vaccine
Secondary outcomes:
measure: 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
timeFrame: At the age of 4 years (48 to 54 months)
measure: 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
timeFrame: In 5 years (78 to 84 months) after the last vaccination of the experimental vaccine or control vaccine
Other outcomes:
Locations:
city: Pizhou
country: China
facility: Pizhou county Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial Center for Disease Prevention and Control
name: Hongxing Pan, Master
role: PRINCIPAL_INVESTIGATOR
References: