The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2021/22. The secondary objectives of the study are: * To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups. * To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period. * To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.
Study duration per participant is maximum 2 months.
Study Type
OBSERVATIONAL
Enrollment
1,804
Intramuscular or subcutaneous administration
Intramuscular administration
Investigational Site Number :2-2-002
Helsinki, Finland
Investigational Site Number :2-2-005
Jyväskylä, Finland
Investigational Site Number :2-2-004
Kuopio, Finland
Investigational Site Number :2-2-003
Tampere, Finland
Investigational Site Number :2-2-011
Turku, Finland
Investigational Site Number :2760005
Blankenhain, Germany
Investigational Site Number :2760008
Bochum, Germany
Investigational Site Number :2760001
Donaueschingen, Germany
Investigational Site Number :2760011
Düsseldorf, Germany
Investigational Site Number :2760007
Frankfurt am Main, Germany
...and 5 more locations
Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
The vaccinees' reporting rate is expressed as the percentage of vaccinees who reported at least one suspected ADR among the distributed vaccination cards
Time frame: Within 7 days after vaccination
ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda®
The ADR reporting rate is expressed as the percentage of suspected ADRs among the distributed vaccination cards
Time frame: Within 7 days after vaccination
ADR reporting rate according to age group
Time frame: Within 7 days after vaccination
Vaccinees' reporting rate according to age group
Time frame: Within 7 days after vaccination
Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period
Serious suspected ADRs will be collected from vaccination up to the end of data collection. Data collection ends when 1000 vaccination cards have been distributed (per vaccine brand) plus 2 weeks or 2 months following the first vaccination, whichever comes first.
Time frame: From vaccination to end of data collection (maximum 2 months following first vaccination)
Serious suspected ADR reporting rate at any time following vaccination within the EPSS period
Serious suspected ADRs will be collected from vaccination up to the end of data collection. Data collection ends when 1000 vaccination cards have been distributed (per vaccine brand) plus 2 weeks or 2 months following the first vaccination, whichever comes first.
Time frame: From vaccination to end of data collection (maximum 2 months following first vaccination)
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