Influenza
Conditions
Brief summary
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) from day 1 to day 7, Number of Participants with Unsolicited Adverse Events (AEs) from day 1 to day 28, Number of Participants with Medically Attended AEs (MAAEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESI) from day 1 to day 181, Time to First Episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Confirmed Protocol Defined ILI (ILI caused by any influenza A or B strain from day 14 up to End of Season (up to approximately day 181)
Detailed description
Number of Participants with First Episode of RT-PCR Confirmed Modified US Centers for Disease Control and Prevention (CDC)-Defined ILI (ILI caused by any influenza A or B strains) from Day 14 up to End of Season (up to approximately Day 181), Number of Participants with First Episode of RT-PCR Confirmed Protocol-Defined ILI or Modified CDC-Defined ILI (ILI caused by influenza A or B strains with antigenic match to the vaccine strains) from Day 14 up to End of Season (up to approximately Day 181), Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) (Humoral immunogenicity) at day 29, Number of Participants Reaching Seroconversion as Measured by HAI at Day 29, Number of Participants with an HAI Titer ≥1:40 at Day 29, Geometric Mean Fold Rise (GMFR) of HAI Titers at Day 1 and Day 29, HAI Titer (As measured by the HAI Assay) at Day 29, Number of Participants with First Episode of RT-PCR-Confirmed Protocol-Defined ILI (Correlates of Risk (CoR) and Correlates of Protection (CoP)) from Day 14 up to End of Season (up to approximately Day 181)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) from day 1 to day 7, Number of Participants with Unsolicited Adverse Events (AEs) from day 1 to day 28, Number of Participants with Medically Attended AEs (MAAEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESI) from day 1 to day 181, Time to First Episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Confirmed Protocol Defined ILI (ILI caused by any influenza A or B strain from day 14 up to End of Season (up to approximately day 181) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with First Episode of RT-PCR Confirmed Modified US Centers for Disease Control and Prevention (CDC)-Defined ILI (ILI caused by any influenza A or B strains) from Day 14 up to End of Season (up to approximately Day 181), Number of Participants with First Episode of RT-PCR Confirmed Protocol-Defined ILI or Modified CDC-Defined ILI (ILI caused by influenza A or B strains with antigenic match to the vaccine strains) from Day 14 up to End of Season (up to approximately Day 181), Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) (Humoral immunogenicity) at day 29, Number of Participants Reaching Seroconversion as Measured by HAI at Day 29, Number of Participants with an HAI Titer ≥1:40 at Day 29, Geometric Mean Fold Rise (GMFR) of HAI Titers at Day 1 and Day 29, HAI Titer (As measured by the HAI Assay) at Day 29, Number of Participants with First Episode of RT-PCR-Confirmed Protocol-Defined ILI (Correlates of Risk (CoR) and Correlates of Protection (CoP)) | — |
Countries
Belgium, Bulgaria, Estonia, Finland, Germany