Phase 3
Completed N=416
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Children
Healthy
Source: ClinicalTrials.gov NCT02263131 ↗
Enrolled (actual)
416
Serious AEs
1.9%
Results posted
Apr 2015
Primary outcomePrimary: Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroconversion — 62.02; 76.81; 53.41; 57.35 percentage of paticipants
Summary
The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single intramuscular injection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroconversion |
62.02; 76.81; 53.41; 57.35; 54.90; 66.18 | — |
| PRIMARY Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination |
60.06; 54.84; 82.76; 66.67; 53.41; 56.45 | — |
| PRIMARY Seroprotection Rate for HI Antibody |
94.96; 89.71; 93.77; 91.18; 95.25; 95.59 | — |
| PRIMARY Seroprotection Rate of HI Antibody |
96.10; 91.94; 82.76; 66.67; 95.45; 93.55 | — |
| SECONDARY Geometric Mean Titer* (GMT) of HI Antibody |
24.40; 24.80; 111.40; 88.45; 31.85; 30.00 | — |
| SECONDARY GMR of HI Antibody Titer Before Vaccination and After Vaccination |
4.57; 3.57; 3.47; 3.50; 3.60; 3.85 | — |
| SECONDARY Number of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer |
35.29; 28.57; 61.90; 50.00; 18.75; 0.00 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy men or women aged from 6 months to 38.0 Cº within 72 hours prior to administration of the study vaccine
- Subject who had previously received another vaccine within 28 days before administration of the study drug, or is scheduled to receive another vaccine during the study period.
- Subject who had received immunosuppressant or immune modifying drug within the last 3 months prior to administration of the study vaccine
- Subject who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or is expecting to be treated with immunoglobulin or blood-derived products during the study.
- Subject who had participated in another experimental study within 30 days prior to administration of the study vaccine
- Subject with other clinically significant medical or psychological condition who in the investigator's opinion would not be suitable for the study.
Data sourced from ClinicalTrials.gov (NCT02263131). 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.