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

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

Outcome

Met primary endpoint

paper The study vaccine group met both primary (i.e., the lower limit of 95% confidence interval [CI] of the seroconversion rate exceeds 40% for four strains) PMID 33736920 ↗

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

Indications

No indication recorded.