drugset / Trial / NCT02985320

Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine

NCT02985320 ↗

Phase 1/2 Completed 708 enrolled Sinovac Biotech Co., Ltd
RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.

Timeline

Start
2016-10
Primary completion
2017-06
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Sabin inactivated poliovirus vaccine Vaccine 0.5 ml Intramuscular
Comparator conventional IPV Vaccine 0.5 ml Intramuscular
Comparator sIPV (CAMS) Vaccine 0.5 ml Intramuscular

Indications