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Not yet recruiting NCT06694025

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

— Observational Immunization Influenza (Healthy Volunteers)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Efluelda Tetra Pre-filled syringe.
Who it may be relevant to
Registry conditions: Immunization, Influenza (Healthy Volunteers). Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Biological Efluelda Tetra Pre-filled syringe
    Suspension for injection in a pre-filled syringe

Primary outcome measures

  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Investigational Site Number : 001 — Seoul

Identifiers

NCT: NCT06694025 · QHD00024 · U1111-1251-6083

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗