Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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

2. Part 2 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.

The investigator will evaluate the efficacy and safety of the test product while clinical trial.

Blood samples will be collected at visit 1 and visit 5 for immunogenicity evaluation. The study subject and their legal guardians will be educated to daily record AEs after vaccination on the patient diary to evaluate the safety.

At visit1, blood samples will be collected from randomized study subjects and investigational drug will be intramuscularly injected. However, those who had not been vaccinated with influenza vaccine, will re-visit and have the 2nd vaccination, 4~5 weeks after the 1st vaccination.

After 4~5 weeks since last vaccination, study subjects will visit and blood sample will be collected. And the serious adverse events occurred during 180 days after the final vaccination will be checked through the telephone visit.

The study subjects with 1 dose of vaccine will have 4 visits including Visit 1~2 and Visit 5~6. The study subjects with 2 dose of vaccine will have 6 visits including Visit 3~4. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03285997
Study type Interventional
Source Green Cross Corporation
Contact Han-A Cha
Phone +82-260-1936
Email hacha@greencross.com
Status Not yet recruiting
Phase Phase 3
Start date September 30, 2017
Completion date August 31, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT05996549 - Cost-effectiveness of the Influenza Vaccination Phase 4
Completed NCT04546854 - Influenza 2020/2021 N/A
Completed NCT05157425 - Effect of a Multi-strain Probiotic Formulation on Immune Response to Influenza Vaccination N/A
Completed NCT01687517 - Efficacy and Safety of Influenza Vaccine During Sarcoidosis Phase 3
Completed NCT01180699 - Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Solid Organ Transplant Recipients N/A
Completed NCT00760175 - Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients N/A
Completed NCT00542776 - Impact of Immunosuppression in IBD Patients on Response to Influenza Vaccine N/A
Completed NCT06304038 - Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome
Recruiting NCT04086628 - Influenza Vaccine in Children With Asthma
Completed NCT02960815 - Imiquimod and Influenza Vaccine for Immunocompromised Patients Phase 2
Completed NCT00828555 - Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting N/A
Completed NCT04230343 - Limits of the Social Benefit Motive Among High-risk Patients: a Field Experiment on Influenza Vaccination Behaviour N/A
Recruiting NCT03399357 - Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population - the DYNAMIC Trial N/A
Completed NCT02153671 - Immunogenicity of H5N1 Vaccine Following H5N2 Phase 2
Completed NCT00461981 - A Phase 2 Study to Evaluate Immune Responses of FluMist® Phase 2
Recruiting NCT05070494 - Efficacy of Different Doses of Influenza Vaccine in Chronic Hemodialysis Patients Phase 4
Completed NCT04785794 - Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old Phase 1
Completed NCT05163847 - Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults Phase 1
Not yet recruiting NCT04355806 - Impact of Inactivated Trivalent Influenza Vaccine on NSCLC Patients Receiving PD-1 / PD-L1 Inhibitors
Completed NCT01368796 - Comparison of 4 Influenza Vaccines in Seniors Phase 4