NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Not Yet RecruitingN/A

Sponsor: Sanofi

Conditions: Immunization, Influenza (Healthy Volunteers)

Interventions: Efluelda Tetra Pre-filled syringe

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 65 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility 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

Locations (1)

Seoul, Seoul-teukbyeolsi, South Korea