Influenza, Human
Conditions
Brief summary
•HI titers at Day 29 •NI titers at Day 29 •HI seroconversion from baseline to Day 29, Solicited AEs • Occurrence of any solicited administration site and systemic events during the 7 days following study intervention administration. Unsolicited AEs • Occurrence of unsolicited AEs during the 28 days following study intervention administration. MAAEs, SAEs and AESIs • Occurrence of SAEs and AESIs up to 6 months following study intervention administration.
Detailed description
• HI titers at Day 29 • HI seroconversion from baseline to Day 29, • Fold increase in HI titers at Day 29 relative to baseline • HI seroprotection at baseline and Day 29 • NI titers at Day 29 • Fold increase in NI titers at Day 29 relative to baseline • NI seroconversion from baseline to Day 29 • Virus neutralization titers at Day 29 by MN assay • Fold increase in virus neutralization titers at Day 29 relative to baseline • Virus neutralization seroconversion from baseline to Day 29
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •HI titers at Day 29 •NI titers at Day 29 •HI seroconversion from baseline to Day 29, Solicited AEs • Occurrence of any solicited administration site and systemic events during the 7 days following study intervention administration. Unsolicited AEs • Occurrence of unsolicited AEs during the 28 days following study intervention administration. MAAEs, SAEs and AESIs • Occurrence of SAEs and AESIs up to 6 months following study intervention administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| • HI titers at Day 29 • HI seroconversion from baseline to Day 29, • Fold increase in HI titers at Day 29 relative to baseline • HI seroprotection at baseline and Day 29 • NI titers at Day 29 • Fold increase in NI titers at Day 29 relative to baseline • NI seroconversion from baseline to Day 29 • Virus neutralization titers at Day 29 by MN assay • Fold increase in virus neutralization titers at Day 29 relative to baseline • Virus neutralization seroconversion from baseline to Day 29 | — |