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

StatusRecruiting
PhaseNot specified
SponsorSanofi
Started

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Record History

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  1. Recruitment opened
    • Trial sites expanded: 0 → 15 locations
    • Start date changed from estimate of Oct 1, 2026 to Sep 17, 2026
    • Eligibility criteria expanded, about 5 words
  2. Start date: Mar 31, 2026 to Oct 1, 2026
    • Eligibility criteria revised
    v4
  3. Start date: Jan 30, 2026 to Mar 31, 2026v3
  4. Start date: Dec 19, 2025 to Jan 30, 2026v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Sanofi
285 trials monitored
See 12 trials at risk
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.
Trial Details
NCT Number NCT07282795
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Influenza Immunization, Healthy Volunteers
Related terms Influenza, Human
Enrollment 670 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov