drugset / Trial / NCT03526978

An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants

NCT03526978 ↗

Phase 3 Completed 1200 enrolled Sinovac Biotech Co., Ltd
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

EvaluationDrugModalityDoseRoute
Subject Sabin strain-based inactivated polio vaccine Vaccine 0.5 ml Intramuscular
Comparator conventional IPV Vaccine 0.5 ml Intramuscular

Indications