drugset / Trial / NCT03526978
An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.
Timeline
- Start
- 2017-08-08
- Primary completion
- 2017-10-18
- Completion
- 2018-04-18
Outcome
Met primary endpoint
paper The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile. PMID 30958543 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sabin strain-based inactivated polio vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | conventional IPV | Vaccine | 0.5 ml | Intramuscular |