COVID-19, Influenza
Conditions
Brief summary
Antibody titers against for each of the 3 influenza vaccine strains (in a subset of participants), Antibody titers against SARS-CoV-2 specific variant (in a subset of participants)
Detailed description
Presence of solicited injection site reactions for 8 days, including the day of vaccination (Main subset of participants), Presence of solicited systemic reactions for 8 days, including the day of vaccination (Main subset of participants), Presence of immediate adverse events after vaccination, Presence of unsolicited adverse events, Presence of all medically attended adverse events, Presence of related medically attended adverse events linked to predefined potential immune-mediated diseases, Presence of all adverse events of special interest, Presence of all serious adverse events, Presence of related serious adverse events, Presence of related adverse events of special interest, Presence of related medical attended adverse events linked to predefined potential immune-mediated diseases that meet the criteria for serious adverse events, Presence of adverse events leading to study discontinuation throughout the study, Influenza seroconversion status after vaccination for each of the 3 influenza vaccine strains, SARS-CoV-2 seroresponse status after vaccination, Neutralizing antibody titers measured by neutralization test (NT) against each of the 3 influenza vaccine strains before and after vaccination (in a subset of participants), Individual neutralizing antibody titer ratio measured by neutralization test NT against each of the 3 influenza vaccine strains after vaccination (in a subset of participants), Neutralizing antibody titer ≥ 10 (1/dil) against each of the 3 influenza vaccine strains after vaccination (in a subset of participants), Neutralizing antibody titer ≥ 20 (1/dil) against each of the 3 influenza vaccine strains after vaccination (in a subset of participants), Neutralizing antibody titer ≥ 40 (1/dil) against each of the 3 vaccine strains after vaccination (in a subset of participants), Neutralizing antibody titer ≥ 80 (1/dil) against each of the 3 influenza vaccine strains after vaccination (in a subset of participants), Fold increase in neutralization test antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants) - ≥ 2-fold rise from Day 01 to Day 29, Fold increase in neutralization test antibody titer against each of the 3 influenza vaccine strains after vaccination (in a subset of participants) - ≥ 4-fold rise from Day 01 to Day 29
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody titers against for each of the 3 influenza vaccine strains (in a subset of participants), Antibody titers against SARS-CoV-2 specific variant (in a subset of participants) | — |
Secondary
| Measure | Time frame |
|---|---|
| Presence of solicited injection site reactions for 8 days, including the day of vaccination (Main subset of participants), Presence of solicited systemic reactions for 8 days, including the day of vaccination (Main subset of participants), Presence of immediate adverse events after vaccination, Presence of unsolicited adverse events, Presence of all medically attended adverse events, Presence of related medically attended adverse events linked to predefined potential immune-mediated diseases, Presence of all adverse events of special interest, Presence of all serious adverse events, Presence of related serious adverse events, Presence of related adverse events of special interest, Presence of related medical attended adverse events linked to predefined potential immune-mediated diseases that meet the criteria for serious adverse events, Presence of adverse events leading to study discontinuation throughout the study, Influenza seroconversion status after vaccination for each of the 3 i | — |