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Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe

Recruitingn/aAges 65 Years - anyAllSanofi
NCT07282795 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 65 years or older on the day of enrollment * The informed consent form has been signed and dated * Receipt of 1 dose of Efluelda® on the day of enrollment according to the approved local product label Exclusion Criteria: * Previous history of enrollment in this study * Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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What it tests

  • Efluelda® Pre-filled syringe
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Where

15 sites
Kintex Dream Internal Medicine Clinic
Goyang-si, South Korea
Kim's gutease internal medicine
Gunpo, South Korea
House ENT clinic
Busan, South Korea
Yoon Jae Woong Neurosurgery Clinic
Busan, South Korea
Centum Family Medicine Clinic
Busan, South Korea
Dr. Jang's Family Medicine Clinic
Daegu, South Korea
Jeon Junha Internal Medicine
Daegu, South Korea
Daol Union Clinic
Daegu, South Korea

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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