A Safety Study of Sabin Inactivated Poliovirus Vaccine in Infants

Sinovac

Status and phase: Completed; Phase 4

Conditions: Poliomyelitis

Treatments: Biological: sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine; Biological: sIPV vaccine /DTaP vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05432141

PRO-sIPV-MA4001-JX

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 3,200 patients

Sex: All

Ages: 2 to 18 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,200 participants in 2 patient groups

Primary immunization group

Experimental group

Description:

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

Treatment:

Biological: sIPV vaccine /DTaP vaccine

Booster immunization group of sIPV vaccine

Experimental group

Description:

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.

Treatment:

Biological: sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine