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Not yet recruiting NCT07282795

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

— Observational Influenza Immunization 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® Pre-filled syringe.
Who it may be relevant to
Registry conditions: Influenza Immunization, 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
Center list to be confirmed — check the primary protocol.
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® Pre-filled Syringe, a High-dose Trivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea

Overview

To objective of this study is to investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda® in adults aged 65 years or older under routine clinical practice, as per approved indications This is an open-label, multi-center, observational active safety surveillance study, designed to be conducted under standard healthcare setting of the Republic of Korea, in accordance with "Regulation on the Operation of Risk Management Plans". 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® Pre-filled syringe
    Pharmaceutical Form: Suspension for injection in a pre-filled syringe Route of Administration: Intramuscular administration

Primary outcome measures

  • Occurrence of solicited injected site reactions. [Time frame: Up to 7 days after vaccination]
  • Occurrence of solicited systemic reactions [Time frame: Up to 7 days after vaccination]
  • Occurrence of unsolicited Adverse Events (AE) [Time frame: From vaccination to Visit 2 (up to approximately 42 days)]
  • Occurrence of unsolicited Adverse Drug Reactions (ADR) [Time frame: From vaccination to Visit 2 (up to approximately 42 days)]
  • Occurrence of unexpected Adverse Events (AE) [Time frame: From vaccination to participant's last contact (up to approximately 42 days)]
  • Occurrence of unexpected Adverse Drug Reactions (ADR) [Time frame: From vaccination to participant's last contact (up to approximately 42 days)]
  • Occurrence of Serious Adverse Events (SAE) [Time frame: From vaccination to participant's last contact (up to approximately 42 days)]
  • Occurrence of unexpected Serious Adverse Drug Reactions (SADR) [Time frame: From vaccination to participant's last contact (up to approximately 42 days)]
  • Occurrence of Adverse Event of Special Interest (AESI) [Time frame: From vaccination to participant's last contact (up to approximately 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® 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07282795 · FIM00018 · U1111-1331-8205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗