Poliomyelitis
Conditions
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.
Interventions
BIOLOGICALInvestigational 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
BIOLOGICALControl 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
Sponsors
Sinovac Biotech Co., Ltd
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
48 Months to 84 Months
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At the age of 4 years (48 to 54 months) after the vaccination of the experimental vaccine or control vaccine | 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. |
| 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 | In 5 years (78 to 84 months) after the last vaccination of the experimental vaccine or control vaccine | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At the age of 4 years (48 to 54 months) | 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. |
| 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 | 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) 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. |
Countries
China
Outcome results
None listed