drugset / Trial / NCT05431933

Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One Booster Dose in the Three Primary Vaccination Plus Boosting Schedule, and Protective Effect in the Schedule With Bivalent OPV in Infants

NCT05431933 ↗

Phase 3 Completed 2001 enrolled LG Chem
RandomizedParallel-groupOpen-labelPrevention

Summary

Eupolio is inactivated poliovirus vaccine (IPV). Major purpose of this study is to evaluate safety of Eupolio in 2,000 infants. In addition to the safety, long-term protection after completion of the three primary vaccinations and extent of protective level after a single boosting dose of Eupolio will be evaluated. As IPV plus bOPV vaccination schedule (3 doses of bOPV plus 2 doses of IPV in infant-toddle vaccination schedule) has been implemented in some countries, this study will also evaluate Eupolio's safety and protective effect in that schedule.

Timeline

Start
2023-01-10
Primary completion
2024-11-06
Completion
2024-11-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Eupolio Vaccine — —

Indications