A Study to Evaluate the Efficacy and Safety of 'GC3110A(QIV)' in Healthy Children

Summary

1. Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form (In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 times or 2 times according to age. 2. Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form(In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), the 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 drug 1 times or 2 times according to age as below; * 6 m \~ 3 years * 3 years \~ 9 years * 9 years \~ 19 years

Timeline

Start

2015-09

Primary completion

2016-06

Completion

2016-06

Publications

• Lee J, Lee KY, Kim JH, Kim CS, Eun BW, Kim HM, Kim DH, Hong YJ, Choi YY, Jo DS, Ma SH, Kang JH. Safety and Immunogenicity of an Egg-Cultivated Quadrivalent Inactivated Split-virion Influenza Vaccine (GC3110A) in Healthy Korean Children: a Randomized, Double-blinded, Active-controlled Phase III Study. J Korean Med Sci. 2018 Mar 26;33(13):e100. doi: 10.3346/jkms.2018.33.e100.

Drugs

Indications