Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. (NCT06694025) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.
South Korea670 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of solicited (pre-listed in the participant's diary card [DC] and case report form) injection site and systemic reactions
Timeframe: From baseline up to 7 days after vaccination
2
Occurrence of unsolicited AEs and ADRs
Timeframe: From baseline up to Visit 2 (28-35 days) after vaccination
3
Occurrence of unexpected AEs and ADRs
Timeframe: 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)
Timeframe: From baseline up to participant's last contact after vaccination (36-42 days)
5
Occurrence of AE of special interest (AESI)
Timeframe: From baseline up to participant's last contact after vaccination (36-42 days)
Trial details
NCT IDNCT06694025
SponsorSanofi
Sponsor typeINDUSTRY
Study typeOBSERVATIONAL
Primary completion2027-12-31
Contact for this trial
Trial Transparency email recommended (Toll free for US & Canada)