A Safety Study of Sabin Inactivated Poliovirus Vaccine in Infants

Poliomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05432141
• Other study ID #: PRO-sIPV-MA4001-JX
• Status: Completed
• Phase: Phase 4
• Start date: June 13, 2022
• Est. completion date: December 13, 2022

Study information

• Verified date: June 2022
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3200
• Est. completion date: December 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 18 Months

Eligibility

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.

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• sIPV vaccine /DTaP vaccine
All subjects received 3 doses of sIPV vaccines and 3 doses of DTaP vaccines. Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children.
• sIPV vaccine /Hepatitis A inactivated vaccine /MMR vaccine
All subjects will receive 1 dose of sIPV and 2 doses of hepatitis A inactivated vaccine/or 1 dose of attenuated hepatitis A vaccine and 1 dose of MMR vaccine.Subjects recommended intramuscular injection. The best site for intramuscular injection is the anterolateral middle thigh for infants and the deltoid muscle for children.

Locations

Country	Name	City	State
China	Gaoan Center for Disease Control and Prevention	Gao'an	Jiangxi
China	Shangli County Center for Disease Control and Prevention	Pingxiang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse reactions within 0~7 days after primary immunization of sIPV vaccine	Incidence of adverse reactions within 0~7 days after primary immunization of sIPV vaccine	Within 0~7 days after primary immunization
Secondary	Incidence of adverse reactions within 0~30 days after primary immunization of sIPV vaccine	Incidence of adverse reactions within 0~30 days after primary immunization of sIPV vaccine.	Within 0~30 days after primary immunization
Secondary	Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine	Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine .	Within 0~7 days after booster immunization
Secondary	Incidence of adverse reactions within 0~30 days after booster immunization of sIPV vaccine	Incidence of adverse reactions within 0~30 days after booster immunization of sIPV vaccine.	Within 0~30 days after booster immunization
Secondary	Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine	Incidence of adverse reactions within 0-7 days after primary immunization of sIPV vaccine combined with DTaP vaccine.	Within 0-7 days after primary immunization combined with DTaP vaccine
Secondary	Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine	Incidence of adverse reactions within 0-30 days after primary immunization of sIPV vaccine combined with DTaP vaccine.	Within 0-30 days after primary immunization combined with DTaP vaccine
Secondary	Incidence of adverse reactions after booster immunization of sIPV vaccine combined with inactivated hepatitis A vaccine	Incidence of adverse reactions within 0~7 days after booster immunization of sIPV vaccine combined with inactivated hepatitis A vaccine.	Within 0~7 days after booster immunization combined with inactivated hepatitis A vaccine
Secondary	Incidence of adverse reactions within 0 ~14 days after booster immunization of sIPV vaccine	Incidence of adverse reactions within 0 ~14 days after booster immunization of sIPV vaccine combined with MMR vaccine or attenuated hepatitis A vaccine.	Within 0 ~14 days after booster immunization
Secondary	Incidence of adverse events within 0 ~ 30 days after booster immunization of sIPV vaccine	Incidence of adverse events within 0 ~ 30 days after booster immunization of sIPV vaccine combined with MMR vaccine ,inactivated hepatitis A vaccine or attenuated hepatitis A vaccine.	Within 0 ~ 30 days after booster immunization of sIPV vaccine combined with MMR vaccine ,inactivated hepatitis A vaccine or attenuated hepatitis A vaccine.