Influenza virus
Conditions
Brief summary
First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the protocol-defined ILI definition.
Detailed description
First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically matched to the vaccine strains selected for the seasonal vaccine, occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the protocol-defined ILI definition., First-occurrence of culture-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), occurring from 14 days after vaccination and until the end of influenza season, using the protocol-defined ILI definition., First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the modified CDC ILI definition as well as the WHO ILI definition., First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically unmatched to the vaccine strains selected for the seasonal vaccine, occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the protocol-defined ILI definition, The measures for immunogenicity as determined by the serum HI antibody titers for Day 1 and Day 22 for four vaccine homologous influenza strains are as follows for the subjects selected for the immunogenicity subset in each season – reference is made to the study protocol, page 79., Safety of the study vaccines will be assessed in all subjects in terms of the frequency of reported AEs including: • All AEs reported within 30 minutes after vaccination; • SAEs reported during the entire study period; • AESIs reported during the entire study period; • AEs leading to premature withdrawal from the study during the entire study period.
Interventions
DRUGFLUARIX (Influenza Vaccine)
DRUGFluad suspension for injection in pre-filled syringe Influenza vaccine (surface antigen
DRUGinactivated
DRUGadjuvanted)
DRUGFluad Tetra
DRUGFluarix Tetra suspensión inyectable en jeringa precargada Vacuna antigripal (de virus fraccionados e inactivados)
Sponsors
Seqirus UK Limited
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the protocol-defined ILI definition. | — |
Secondary
| Measure | Time frame |
|---|---|
| First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically matched to the vaccine strains selected for the seasonal vaccine, occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the protocol-defined ILI definition., First-occurrence of culture-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), occurring from 14 days after vaccination and until the end of influenza season, using the protocol-defined ILI definition., First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the modified CDC ILI definition as well as the WHO ILI definition., First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically unmatched to the vaccine strains selected f | — |
Countries
Belgium, Bulgaria, Czechia, Finland, Italy, Lithuania, Netherlands, Poland, Romania, Spain
Outcome results
None listed