drugset / Trial / NCT05386810

Safety of Sabin Inactivated Poliovirus Vaccine in Adults, Children and Infants and Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants

NCT05386810

Phase 3 Completed 1572 enrolled Sinovac Biotech Co., Ltd
RandomizedParallel-groupDouble-blindPrevention

Summary

This study includes two parts.A clinical trial with a open-label to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml-5 doses)(hereinafter referred to as "msIPV")manufactured by Sinovac Biotech Co., Ltd. in adults, children and infants in partⅠ and a blinded,randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msIPV in 2 months old infants in partⅡ.

Timeline

Start
2020-11-05
Primary completion
2022-10-08
Completion
2023-07-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Inactivated Polio Vaccine Vaccine 0.5 ml
Comparator Sabin Inactivated Poliovirus Vaccine (Vero cell) Vaccine 0.5 ml

Indications