NCT05432141

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,200 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 2 Months – 18 Months
• Healthy volunteers: Accepted

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.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
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.
BIOLOGICAL	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.

Timeline

• Start date: 2022-06-13
• Primary completion: 2022-09-13
• Completion: 2022-12-13
• First posted: 2022-06-27
• Last updated: 2023-01-12

Locations

2 sites across 1 country: China