Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT02677493
Brief Summary:
This study evaluates the immunogenicity and safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.' in healthy male and female adults at the age of 19 or older.
Detailed Description:
In this study, only eligible subjects for the study based on the inclusion/exclusion criteria will be randomized to the following stratification groups by age to receive one dose of the test vaccine, comparator 1, or comparator 2.
* Group A: healthy adults at the age of ≥ 19 and \< 65.
* Group B: healthy adults at the age of ≥ 65.
During the study participation, the investigator will assess immunogenicity and safety in subjects. The investigator will perform immunogenicity tests at Visits 1 and 3 (end of study visit) for immunogenicity evaluation (prior to the investigational product vaccination) and instruct subjects to record AEs occurring after the investigational product vaccination for safety assessment.
A blood sample will be collected from a subject who is assigned a subject number. Following an intramuscular injection of 0.5mL investigational product in the deltoid muscle of the shoulder, the subject will have a study visit on Week 4 for blood sampling for antibody titer testing. In addition, a telephone visit will be performed to assess serious AEs (SAEs) up to Day 180 after vaccination.
Study:
NCT02677493
Study Brief:
Protocol Section:
NCT02677493