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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Inactivated Polio Vaccine | Vaccine | 0.5 ml | — |
| Comparator | Sabin Inactivated Poliovirus Vaccine (Vero cell) | Vaccine | 0.5 ml | — |