SARS-CoV-2 and Influenza
Conditions
Brief summary
Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination., Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study., Number and percentage of serious adverse events (SAEs) through the end of the study., Number and percentage of adverse events of special interest (AESI) through the end of the study.
Detailed description
Binding antibodies titre measured for each individual sample and GMT for treatment group comparison at Baseline and at Day 28 elicited by BIMERVAX® when coadministered with SIIV or administered alone., Geometric mean fold rise (GMFR) in binding antibodies titre from Baseline and Day 28 elicited by BIMERVAX® when coadministered with SIIV or administered alone., Strain specific HAI antibody titers (expressed as GMT) at Baseline and at Day 28, elicited by SIIV when coadministered with BIMERVAX®, or administered alone., Geometric mean fold rise (GMFR) in strain specific HAI titers elicited at Day 28 by SIIV when coadministered with BIMERVAX® or administered alone.
Interventions
Sponsors
Hipra Scientific S.L.
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination., Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study., Number and percentage of serious adverse events (SAEs) through the end of the study., Number and percentage of adverse events of special interest (AESI) through the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Binding antibodies titre measured for each individual sample and GMT for treatment group comparison at Baseline and at Day 28 elicited by BIMERVAX® when coadministered with SIIV or administered alone., Geometric mean fold rise (GMFR) in binding antibodies titre from Baseline and Day 28 elicited by BIMERVAX® when coadministered with SIIV or administered alone., Strain specific HAI antibody titers (expressed as GMT) at Baseline and at Day 28, elicited by SIIV when coadministered with BIMERVAX®, or administered alone., Geometric mean fold rise (GMFR) in strain specific HAI titers elicited at Day 28 by SIIV when coadministered with BIMERVAX® or administered alone. | — |
Countries
Spain
Outcome results
None listed