Status:
COMPLETED
A Safety Study of Sabin Inactivated Poliovirus Vaccine in Infants
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Poliomyelitis
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
Brief Summary
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 c...
Detailed Description
This study is an open and observational phase Ⅳ clinical trial of Sabin Inactivated Poliovirus Vaccine.The purpose of this study is to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero...
Eligibility Criteria
Inclusion
- Infants aged 2-3 months should be involved in primary immunization and they have not received Sabin strain inactivated polio vaccine (Vero Cell) in the past;
- Children aged 18 months should be immunized with the first three doses of Sabin strain inactivated polio vaccine (Vero Cell) and they have not received any inactivated or attenuated live vaccines in the past 14 days;
- The guardian agrees to sign the informed consent and voluntarily use the mobile APP to participate in the follow-up visits.
Exclusion
- Allergic to the active ingredient in the vaccine, any inactive ingredient, or substance used in the manufacturing process;
- Allergic to this product or similar vaccines in the past;
- Patients with severe chronic diseases or allergies;
- Patients with fever or acute illness.
- The Exclusion Criteria for the Second and Third Doses:
- Any serious adverse events that are causally related to vaccination;
- Severe anaphylaxis or hypersensitivity after vaccination (including hives and rashes within 30 minutes of vaccination);
- Any confirmed or suspected autoimmune or immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
- Acute or newly emerging chronic diseases occur at the time of vaccination;
- Other reactions (including severe pain, severe swelling, severe limitation of movement, persistent high fever, severe headache, or other systemic or local reactions), as determined by the investigator;
- Having an acute illness at the time of vaccination (acute illness is defined as moderate or severe illness with or without fever);
- Axillary temperature \>37℃ during vaccination.
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2022
Estimated Enrollment :
3200 Patients enrolled
Trial Details
Trial ID
NCT05432141
Start Date
June 13 2022
End Date
December 13 2022
Last Update
January 12 2023
Active Locations (2)
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1
Gaoan Center for Disease Control and Prevention
Gao’an, Jiangxi, China, 330899
2
Shangli County Center for Disease Control and Prevention
Pingxiang, Jiangxi, China