Trial intelligence / Profile preview

Safety and Immunogenicity of Eupolio in Infants

NCT05431933Phase 3

Key facts

Status: Completed
Start: Jan 2023
Primary completion: Nov 2024
Countries: 2
Sponsor: LG Chem
Modality: Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics

Drugs: inactivated poliomyelitis vaccine (Sabin strains)
Conditions: poliomyelitis

Overview

Phase 3, randomised, open-label trial of inactivated poliomyelitis vaccine (Sabin strains) in poliomyelitis (3 arms), sponsored by LG Chem. Primary endpoints: Immediate reaction, Solicited adverse event and 1 more. Started Jan 2023; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

Safety group
Eupolio at 6, 10, 14 weeks
Immunogenicity group 1
Eupolio at 6, 10, 14 weeks + Booster at 1 year
Immunogenicity group 2
bOPV at 6, 10, 14 weeks; Eupolio at 14, 40 weeks

Endpoints

Primary

Immediate reaction30 minutes after each vaccination
Solicited adverse event7 days after each vaccination
Unsolicited adverse event28 days after each vaccination

Secondary

Seroprotection rate4 weeks after 1st and 2nd dose (Group 2)
Geometric mean titers4 weeks after 1st and 2nd dose (Group 2)
Priming response7 days after booster
Seroconversion rate4 weeks after 1st and 2nd dose (Group 2)

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