A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age

Phase 3 Unknown 260 enrolled Green Cross Corporation

RandomizedParallel-groupQuadruple-blindPrevention

Summary

If study subject's legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Formed, study subjects eligible for participating this trial protocol were assigned to test group or control group with the ratio of 4:1 and receiving the test or control drug 1 time or 2 times.

Timeline

Start: 2017-09-30
Primary completion: 2018-05-31
Completion: 2018-08-31

Publications

Choi UY, Kim KH, Lee KY, Kim JH, Kim CS, Eun BW, Kim HM, Kim DH, Song SE, Jo DS, Lee J, Ma SH, Kim KN, Kang JH. Active-controlled phase III study of an egg-cultivated quadrivalent inactivated split-virion influenza vaccine (GC3110A) in healthy Korean children aged 6-35 months. Vaccine. 2021 Apr 8;39(15):2103-2109. doi: 10.1016/j.vaccine.2021.03.005. Epub 2021 Mar 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GC3110A	Vaccine	0.5 ml	Intramuscular
Comparator	Influenza Virus Vaccine	Vaccine	0.25 ml	Intramuscular

Indications

No indication recorded.