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NCT Number: NCT07282795

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

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.

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Key information

Conditions

Influenza Immunization Healthy Volunteers Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Efluelda® Pre-filled syringe

Biological

Pharmaceutical Form:

Suspension for injection in a pre-filled syringe Route of Administration: Intramuscular administration

Primary outcomes

  1. Occurrence of solicited injected site reactions.

    Time frame: Up to 7 days after vaccination

    Number of participants experiencing solicited injection site reactions

  2. Occurrence of solicited systemic reactions

    Time frame: Up to 7 days after vaccination

    Number of participants experiencing solicited systemic reactions

  3. Occurrence of unsolicited Adverse Events (AE)

    Time frame: From vaccination to Visit 2 (up to approximately 42 days)

    Number of participants experiencing AEs

  4. Occurrence of unsolicited Adverse Drug Reactions (ADR)

    Time frame: From vaccination to Visit 2 (up to approximately 42 days)

    Number of participants experiencing ADRs

  5. Occurrence of unexpected Adverse Events (AE)

    Time frame: From vaccination to participant's last contact (up to approximately 42 days)

    Number of participants experiencing unexpected AEs

  6. Occurrence of unexpected Adverse Drug Reactions (ADR)

    Time frame: From vaccination to participant's last contact (up to approximately 42 days)

    Number of participants experiencing unexpected ADRs

  7. Occurrence of Serious Adverse Events (SAE)

    Time frame: From vaccination to participant's last contact (up to approximately 42 days)

    Number of participants experiencing SAEs

  8. Occurrence of unexpected Serious Adverse Drug Reactions (SADR)

    Time frame: From vaccination to participant's last contact (up to approximately 42 days)

    Number of participants experiencing unexpected SADRs

  9. Occurrence of Adverse Event of Special Interest (AESI)

    Time frame: From vaccination to participant's last contact (up to approximately 42 days)

    Number of participants experiencing AESIs

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 15, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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