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NCT Number: NCT06694025

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

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.

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Key information

Conditions

Immunization Infections Influenza (Healthy Volunteers) 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

Primary location

Investigational Site Number : 001

Seoul, Seoul-teukbyeolsi, 07441, South Korea

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 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

Treatment and study plan

Efluelda Tetra Pre-filled syringe

Biological

Suspension for injection in a pre-filled syringe

Primary outcomes

  1. 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

  2. Occurrence of unsolicited AEs and ADRs

    Time frame: From baseline up to Visit 2 (28-35 days) after vaccination

  3. Occurrence of unexpected AEs and ADRs

    Time frame: From baseline up to participant's last contact after vaccination (36-42 days)

  4. 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)

  5. Occurrence of AE of special interest (AESI)

    Time frame: From baseline up to participant's last contact after vaccination (36-42 days)

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 Tetra Pre-filled Syringe, a High-dose Quadrivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea.

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 19, 2024
Registry last updated
Dec 15, 2025

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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