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The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell)(sIPV)in the primary immunization of infants at the age of 2 months and booster immunization of children at the age of 18 months, and the simultaneous immunization with other vaccines of children at the age of 2 months and older, so as to provide reference for the improvement of immunization strategy.
This study is an open and observational phase â…£ clinical trial of Sabin Inactivated Poliovirus Vaccine.The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell)(sIPV)in the primary immunization of infants at the age of 2 months and booster immunization of children at the age of 18 months, and the simultaneous immunization with other vaccines of children at the age of 2 months and older, so as to provide reference for the improvement of immunization strategy.A total of 3200 subjects including 2000 subjects aged 2~3 months in primary immunization group,1200 subjects aged 18 months in primary immunization group will be enrolled and will receive sIPV vaccine or sIPV vaccine and other vaccines simultaneously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary immunization group | Experimental | A total of 2000 infants aged 2-3 months will randomly assigned to two groups according to 1:1 using scratch cards: 1000 infants in the sIPV vaccine group and 1000 infants in the sIPV vaccine group plus DTaP vaccine group |
|
| Booster immunization group of sIPV vaccine | Experimental | A total of 1200 children aged 18 months will randomly assigned to four groups according to 2:2:1:1 using scratch cards: 400 in the sIPV booster group, 400 in the sIPV booster group plus inactivated hepatitis A vaccine simultaneously, 200 in the sIPV booster group plus MMR simultaneously, and 200 in the sIPV booster group plus attenuated hepatitis A vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sIPV vaccine /DTaP vaccine | Biological | All subjects received 3 doses of sIPV vaccines and 3 doses of DTaP vaccines. Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions within 0~7 days after primary immunization of sIPV vaccine | Incidence of adverse reactions within 0~7 days after primary immunization of sIPV vaccine | Within 0~7 days after primary immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions within 0~30 days after primary immunization of sIPV vaccine | Incidence of adverse reactions within 0~30 days after primary immunization of sIPV vaccine. | Within 0~30 days after primary immunization |
| Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine |
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Inclusion Criteria:
Exclusion Criteria:
The Exclusion Criteria for the Second and Third Doses:
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| Name | Affiliation | Role |
|---|---|---|
| Shicheng Guo, Master | Jiangxi Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaoan Center for Disease Control and Prevention | Gao’an | Jiangxi | 330899 | China | ||
| Shangli County Center for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39088987 | Derived | Guo S, Li Z, Zheng M, Wu F, Sun J, Tuo L, Li S, Li X, Wei L, Xia Z, Xie P, Chen X, Zhao Y, Gao Y, Yu D. Safety and 6-month immune persistence of inactivated poliovirus vaccine (Sabin strains) simultaneously administrated with other vaccines for primary and booster immunization in Jiangxi Province, China. Vaccine. 2024 Aug 30;42(21):126183. doi: 10.1016/j.vaccine.2024.126183. Epub 2024 Jul 31. |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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|
| sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine | Biological | All subjects will receive 1 dose of sIPV and 2 doses of hepatitis A inactivated vaccine/or 1 dose of attenuated hepatitis A vaccine and 1 dose of MMR vaccine.Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children. |
|
Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine . |
| Within 0~7 days after booster immunization |
| Incidence of adverse reactions within 0~30 days after booster immunization of sIPV vaccine | Incidence of adverse reactions within 0~30 days after booster immunization of sIPV vaccine. | Within 0~30 days after booster immunization |
| Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine | Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine. | Within 0-7 days after primary immunization combined with DTaP vaccine |
| Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine | Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine combined with DTaP vaccine. | Within 0-30 days after primary immunization combined with DTaP vaccine |
| Incidence of adverse reactions after booster immunization of sIPV vaccine combined with inactivated hepatitis A vaccine | Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine combined with inactivated hepatitis A vaccine. | Within 0~7 days after booster immunization combined with inactivated hepatitis A vaccine |
| Incidence of adverse reactions within 0 ~14 days after booster immunization of sIPV vaccine | Incidence of adverse reactions within 0 ~14 days after booster immunization of sIPV vaccine combined with MMR vaccine or attenuated hepatitis A vaccine. | Within 0 ~14 days after booster immunization |
| Incidence of adverse events within 0 ~ 30 days after booster immunization of sIPV vaccine | Incidence of adverse events within 0 ~ 30 days after booster immunization of sIPV vaccine combined with MMR vaccine ,inactivated hepatitis A vaccine or attenuated hepatitis A vaccine. | Within 0 ~ 30 days after booster immunization of sIPV vaccine combined with MMR vaccine ,inactivated hepatitis A vaccine or attenuated hepatitis A vaccine. |
| Pingxiang |
| Jiangxi |
| China |
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D045424 |
| Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| D008458 | Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |