To investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda Tetra in adults aged 65 years or older under routine clinical practice, as per approved indications. The study duration of each participation will be approximately 28 to 35 days. In the event that Visit 2 is not made, the study duration would be extended to 36 to 42 days.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Occurrence of solicited (pre-listed in the participant's diary card [DC] and case report form) injection site and systemic reactions
Timeframe: From baseline up to 7 days after vaccination
Occurrence of unsolicited AEs and ADRs
Timeframe: From baseline up to Visit 2 (28-35 days) after vaccination
Occurrence of unexpected AEs and ADRs
Timeframe: From baseline up to participant's last contact after vaccination (36-42 days)
Occurrence of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)
Timeframe: From baseline up to participant's last contact after vaccination (36-42 days)
Occurrence of AE of special interest (AESI)
Timeframe: From baseline up to participant's last contact after vaccination (36-42 days)
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