Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorSanofi
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Efluelda Tetra Pre-filled syringe
Treatment groups
670 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov