An observational study in Poliomyelitis, sponsored by Sinovac Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 48 Months to 84 Months. Per ClinicalTrials.gov, last updated 2023-01-12.
Sponsored by Sinovac Biotech Co., Ltd · Observational
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.
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.
222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.
This study's enrollment of 450 is close to the median of 450 across 19 observational studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →Sinovac Biotech Co., Ltd is the lead sponsor of 89 studies on the registry; 18 are open to participants now.
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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.
Exclusion Criteria:
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.
Biological: Investigational sIPV
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.
Biological: Control IPV
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
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
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.
Time frame: At the age of 4 years (48 to 54 months) after the vaccination of the experimental vaccine or control vaccine
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.
Time frame: In 5 years (78 to 84 months) after the last vaccination of the experimental vaccine or control vaccine
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.
Time frame: At the age of 4 years (48 to 54 months)
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.
Time frame: In 5 years (78 to 84 months) after the last vaccination of the experimental vaccine or control vaccine
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Sinovac Biotech Co., Ltd