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

ConditionsImmunizationInfluenza (Healthy Volunteers)
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

This trial accepts healthy volunteers

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 population

Investigators will recruit participants after vaccination with Efluelda Tetra as per routine healthcare visits and according to approved local product labeling, at study centers (general hospitals or clinics located in Korea).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Efluelda Tetra Pre-filled syringe

    Biological/Vaccine

    Suspension for injection in a pre-filled syringe

Treatment groups

670 Participants
are divided into 1 treatment group
Group A: Efluelda group1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of solicited (pre-listed in the participant's diary card [DC] and case report form) injection site and systemic reactions

Time frame
From baseline up to 7 days after vaccination
2

Occurrence of unsolicited AEs and ADRs

Time frame
From baseline up to Visit 2 (28-35 days) after vaccination
3

Occurrence of unexpected AEs and ADRs

Time frame
From baseline up to participant's last contact after vaccination (36-42 days)
4

Occurrence of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)

Time frame
From baseline up to participant's last contact after vaccination (36-42 days)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: