To objective of this study is to investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda® in adults aged 65 years or older under routine clinical practice, as per approved indications This is an open-label, multi-center, observational active safety surveillance study, designed to be conducted under standard healthcare setting of the Republic of Korea, in accordance with "Regulation on the Operation of Risk Management Plans". 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.
Age range
65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Occurrence of solicited injected site reactions.
Timeframe: Up to 7 days after vaccination
Occurrence of solicited systemic reactions
Timeframe: Up to 7 days after vaccination
Occurrence of unsolicited Adverse Events (AE)
Timeframe: From vaccination to Visit 2 (up to approximately 42 days)
Occurrence of unsolicited Adverse Drug Reactions (ADR)
Timeframe: From vaccination to Visit 2 (up to approximately 42 days)
Occurrence of unexpected Adverse Events (AE)
Timeframe: From vaccination to participant's last contact (up to approximately 42 days)
Occurrence of unexpected Adverse Drug Reactions (ADR)
Timeframe: From vaccination to participant's last contact (up to approximately 42 days)
Occurrence of Serious Adverse Events (SAE)
Timeframe: From vaccination to participant's last contact (up to approximately 42 days)
Trial Transparency email recommended (Toll free for US & Canada)
Occurrence of unexpected Serious Adverse Drug Reactions (SADR)
Timeframe: From vaccination to participant's last contact (up to approximately 42 days)
Occurrence of Adverse Event of Special Interest (AESI)
Timeframe: From vaccination to participant's last contact (up to approximately 42 days)