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NCT06694025 | NOT YET RECRUITING | Immunization

Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.
Sponsor:

Sanofi

Brief Summary:

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.

Condition or disease

Immunization

Influenza (Healthy Volunteers)

Intervention/treatment

Efluelda Tetra Pre-filled syringe

Study Type : OBSERVATIONAL
Estimated Enrollment : 670 participants
Official Title : Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe, a High-dose Quadrivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea.
Actual Study Start Date : 2024-11-22
Estimated Primary Completion Date : 2028-03-30
Estimated Study Completion Date : 2030-12-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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 Tetra 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
Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.

Location Details

NCT06694025

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Korea, Republic of,

Investigational Site 001

Seoul, Korea, Republic of,