A Safety Study of Sabin Inactivated Poliovirus Vaccine in Infants

Safety Observation of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Primary Immunization, Booster Immunization and Simultaneous Vaccination With Other Vaccines in Infants

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 Ⅳ 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.

Inclusion Criteria:

• 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 Criteria:

• 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.