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

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NCT06694025 · readout in 499 d

Sponsored by Sanofi (industry) · SNY — their whole pipeline →.

Phase

—

Status

Not yet recruiting

Study type

Observational

Enrollment

670estimated

Sites

Country

South Korea

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2026-10-01

estimated

When the study began enrolling

Primary completion

2027-12-31

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2028-01-31

estimated

The whole study's end, after follow-up

First posted

2024-11-19

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2025-12-15

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Immunization
Influenza (Healthy Volunteers)

Intervention

Biological: Efluelda Tetra Pre-filled syringe

Primary outcomes

what the primary-completion date above is the date OF

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)

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