Phase 2
Completed N=84
Study to Evaluate the Safety and Immunogenicity of 'IL-YANG Flu Vaccine Quadrivalent Inj' in Healthy Korean Adults
Influenza, Human
Source: ClinicalTrials.gov NCT02480998 ↗
Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Seroconversion Rate — 58.93; 64.29; 64.29; 53.57 percentage of participants
Summary
This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in healthy Korean males and females 19 to < 65 years of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroconversion Rate |
58.93; 64.29; 64.29; 53.57; 55.36; 35.71 | — |
| PRIMARY Seroprotection Rate |
94.64; 85.71; 96.43; 82.14; 87.50; 78.57 | — |
| SECONDARY GMR |
5.32; 8.41; 6.90; 6.73; 3.85; 2.90 | — |
| SECONDARY GMT |
128; 110.40; 176.70; 128.00; 73.36; 51.24 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy men and women 19 to 38.0 Cº within 72 hours prior to administration of the investigational product or symptoms of suspected acute disease within 14 days prior to administration of the investigational product
- Subjects who had received another vaccine within 28 days before administration of the investigational product or are planning to receive another vaccine during the study.
- Subjects who had participated in another clinical trial within the 30 days before administration of the investigational product.
- Subjects who had previously received blood-derived products (including immunoglobulin) within the last 3 months prior to administration of the Investigational product, or are scheduled to receive a treatment with blood-derived products during the study
- Subjects who had received, or are scheduled to receive, systemic immunosuppressive therapy, radiation therapy or high-dose steroid therapy within the last 6 months prior to administration of the study
- Subjects with a history of drug abuse within the last 6 months prior to vaccination, or is suspected of drug abuse
- Subjects with excessive consumption of caffeine, alcohol, or tobacco
- Subjects with other clinically significant medical or psychiatric illness who in the investigator's opinion, are not be suitable for the study
Data sourced from ClinicalTrials.gov (NCT02480998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.