Clinical trial NCT05432141: A Safety Study of Sabin Inactivated Poliovirus Vaccine in Infants
Official title: Safety Observation of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in Primary Immunization, Booster Immunization and Simultaneous Vaccination With Other Vaccines in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Poliomyelitis
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 3200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse reactions within 0~7 days after primary immunization of sIPV vaccine
timeFrame: Within 0~7 days after primary immunization
Secondary outcomes:
measure: Incidence of adverse reactions within 0~30 days after primary immunization of sIPV vaccine
timeFrame: Within 0~30 days after primary immunization
measure: Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine
timeFrame: Within 0~7 days after booster immunization
measure: Incidence of adverse reactions within 0~30 days after booster immunization of sIPV vaccine
timeFrame: Within 0~30 days after booster immunization
measure: Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine
timeFrame: Within 0-7 days after primary immunization combined with DTaP vaccine
measure: Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine
timeFrame: Within 0-30 days after primary immunization combined with DTaP vaccine
measure: Incidence of adverse reactions after booster immunization of sIPV vaccine combined with inactivated hepatitis A vaccine
timeFrame: Within 0~7 days after booster immunization combined with inactivated hepatitis A vaccine
measure: Incidence of adverse reactions within 0 ~14 days after booster immunization of sIPV vaccine
timeFrame: Within 0 ~14 days after booster immunization
measure: Incidence of adverse events within 0 ~ 30 days after booster immunization of sIPV vaccine
timeFrame: Within 0 ~ 30 days after booster immunization of sIPV vaccine combined with MMR vaccine ,inactivated hepatitis A vaccine or attenuated hepatitis A vaccine.
Other outcomes:
Locations:
city: Gao'an
country: China
facility: Gaoan Center for Disease Control and Prevention
state: Jiangxi
city: Pingxiang
country: China
facility: Shangli County Center for Disease Control and Prevention
state: Jiangxi
Study officials:
affiliation: Jiangxi Provincial Center for Disease Prevention and Control
name: Shicheng Guo, Master
role: PRINCIPAL_INVESTIGATOR
References: