Immunogenicity of After Primary Immunization and Booster Immunization of sIPV

Study Overview
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Brief Summary
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This study was conducted on the basis of Safety Observation of Sabin Strain Inactivated Polio Vaccine (Vero Cell) on primary Immunization, Booster Immunization and Simultaneous Vaccination with Other Vaccines in Infants and Young Children(ID: PRO-sIPV-MA4001-JX). Blood samples were collected in about 200 qualified subjects 1-9 months after their last vaccination of sIPV. And immunogenicity of sIPV and other vaccines simultaneously administrated will be tested, the antibodies against enterovirus (including EV71、CA16、CA6 and CA10) will also be tested.

Official Title
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Immunogenicity After Primary Immunization and Booster Immunization of Sabin Strain Inactivated Polio Vaccine (Vero Cells) in Infants and Young Children and Enterovirus Serological Monitoring Study

Conditions
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Polio

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participated in the previous study (ID: PRO-sIPV-MA4001-JX) Subjects in the Primay immunization group(aged 2-3 months) need to complete 3 doses of sIPV vaccination, and the simultaneous vaccination group DTaP needs to complete 3 doses of vaccination; the booster immunity group(aged more than 18 months) needs to complete sIPV vaccination, and the simultaneous vaccination group needs to complete the corresponding vaccination; There should be an interval of 1-9 months between the last dose of vaccination and the date of blood sample collection; The guardian of subjects need to agree to sign the informed consent form. Exclusion Criteria: The interval between vaccination and blood collection is less than 1 month, or more than 9 months; Subjects were participating in other clinical studies of vaccines or drugs; Other conditions that make subjects unsuitable for participating in this study judged by investigator's

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 27 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2-3 months infants group<br>Subjects in this group had recieved three dose of sIPV as primay immunization, and about half of them recieved DTaP simultaneously. | Other: no intervention<br>* This is an observation study after vaccination, no intervention will be used<br>|
| 18 months children group<br>Subjects in this group had recieved one dose of sIPV as booster immunization, and about half of them recieved MMR or hepatitis A vacine(live-attenuated or inactivated) simultaneously. | Other: no intervention<br>* This is an observation study after vaccination, no intervention will be used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody positivity rate of sIPV vaccine after primary immunization in infants |  | 1 month | 
| Antibody positivity rate of sIPV after booster immunization with sIPV vaccine in young children |  | 1 month | 
| seropositive rate of antibodies against different enteroviruses (EV71/CA16/CA6/CA10) in infants and young children |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT of sIPV vaccine after primary immunization in infants |  | 1 month | 
| GMT of sIPV after booster immunization with sIPV vaccine in young children |  | 1 month | 
| GMT of antibodies against different enteroviruses |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunogenicity of sIPV, primary immunization, booster immunization, simulteneous immunization, serology of antibodies against enterovirus