ImmunizationNCT06694025
Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.
An observational study of Immunization and Influenza (Healthy Volunteers), run by Sanofi at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunization, Influenza (Healthy Volunteers)
- What is being tested?
- Efluelda Tetra Pre-filled syringe
- Type of treatment
- Injection or infusion
- How many people
- 670 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2026to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study 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).
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
South Korea1 site
Investigational Site Number : 001
Seoul, Seoul-teukbyeolsi, 07441
About this study
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.
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.
- Conditions
- Immunization, Influenza (Healthy Volunteers)
- Being tested
- Efluelda Tetra Pre-filled syringe
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efluelda Tetra Pre-filled syringeBiological
Suspension for injection in a pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| Efluelda group | A single dose of 0.7 mL is administered as approved by MFDS. Receives: Biological: Efluelda Tetra Pre-filled syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited (pre-listed in the participant's diary card [DC] and case report form) injection site and systemic reactions
Measured: From baseline up to 7 days after vaccination
Occurrence of unsolicited AEs and ADRs
Measured: From baseline up to Visit 2 (28-35 days) after vaccination
Occurrence of unexpected AEs and ADRs
Measured: From baseline up to participant's last contact after vaccination (36-42 days)
Occurrence of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)
Measured: From baseline up to participant's last contact after vaccination (36-42 days)
Occurrence of AE of special interest (AESI)
Measured: From baseline up to participant's last contact after vaccination (36-42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunizationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694025
- Sponsor's protocol ID
- QHD00024
- Other IDs
- U1111-1251-6083
- Status last verified
- Dec 2025
- First submitted
- 15 Nov 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06694025
- Acronym / sponsor ID
- QHD00024
- Conditions
- Immunization, Influenza (Healthy Volunteers)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efluelda group | – | Biological: Efluelda Tetra Pre-filled syringeA single dose of 0.7 mL is administered as approved by MFDS. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efluelda Tetra Pre-filled syringeSuspension for injection in a pre-filled syringe | Biological | Efluelda group |
Primary outcome
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
Occurrence of unsolicited AEs and ADRs
Time frame: From baseline up to Visit 2 (28-35 days) after vaccination
Occurrence of unexpected AEs and ADRs
Time frame: From baseline up to participant's last contact after vaccination (36-42 days)
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)
Occurrence of AE of special interest (AESI)
Time frame: From baseline up to participant's last contact after vaccination (36-42 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunization and Influenza (Healthy Volunteers), run by Sanofi at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.