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NCT Number: NCT07200206

A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea

This study is conducted as part of the local risk management plan to collect and understand the following information about the surveillance drug under the real-world clinical practice settings.

To evaluate the safety of Beyfortus in Korean children who received Beyfortus under the real-world clinical practice settings per the approved indication. The investigator will decide whether to enroll participants if they determine that administering Beyfortus according to current practice can provide clinical benefits in terms of safety and efficacy Participants will be followed-up for 180 days after Beyfortus administration.

Recruiting

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Key information

Conditions

Respiratory Syncytial Virus

Age range

0 day–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Nam Seung Woo Pediatric: 4100007

Hwaseong-si, Gyeonggi-do, 18478, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children up to 24 months of age who received Beyfortus according to the approved indications.
  • Informed consent signed by the parents / legally accepted representatives (LARs) of the participant.

Exclusion criteria

  • Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device or a medical procedure.
  • Any contraindications according to the approved local product label of Beyfortus.

Treatment and study plan

Nirsevimab

Biological

Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection

Other names: Beyfortus™

Primary outcomes

  1. Occurence of Adverse Events (AEs)

    Time frame: Up to 180 days post dose

    Number of participants (and occurrences) experiencing AEs will be assessed.

  2. Occurence of Serious Adverse Events (SAEs)

    Time frame: Up to 180 days post dose

    Number of participants (and occurrences) experiencing SAEs will be assessed.

  3. Occurrence of AE of special interest (AESI)

    Time frame: Up to 180 days post dose

    Number of participants (and occurrences) experiencing AESI will be assessed. The definition of AESI is as follow:

    • Hypersensitivity, including anaphylaxis
    • Immune complex disease
    • Thrombocytopenia

  4. Occurence of Adverse Drug Reaction (ADRs) as Specified in Approved Local Label

    Time frame: Up to 180 days post dose

    Number of participants (and occurrences) experiencing ADRs will be assessed.

  5. Occurrence of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)

    Time frame: Up to 180 days post dose

    Number of participants (and occurrences) experiencing RSV LRTI will be assessed.

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

A Prospective, Single-arm, Non-interventional, Multi-center, Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 1, 2025
Registry last updated
Dec 3, 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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