A Safety Study of Sabin Inactivated Poliovirus Vaccine in Infants

This is an interventional prevention trial for Poliomyelitis Read More

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.