Trials / Not Yet Recruiting
Not Yet RecruitingNCT06694025
Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.
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.
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 670 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Efluelda Tetra Pre-filled syringe | Suspension for injection in a pre-filled syringe |
Timeline
- Start date
- 2026-10-01
- Primary completion
- 2027-12-31
- Completion
- 2028-01-31
- First posted
- 2024-11-19
- Last updated
- 2025-12-15
Locations
1 site across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06694025. Inclusion in this directory is not an endorsement.