Respiratory Syncytial VirusNCT07200206
A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
An observational study of Respiratory Syncytial Virus, run by Sanofi at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 days to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- Nirsevimab
- Type of treatment
- Injection or infusion
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2025to 26 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children up to 24 months of age who are scheduled to receive Beyfortus according to the approved indications will be selected as participants under the real-world clinical practice settings during the surveillance period after the contract date at the institution. The participants must meet all study inclusion criteria and must not meet any of the study exclusion criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
South Korea1 site, 1 recruiting
- Recruiting
Nam Seung Woo Pediatric: 4100007
Hwaseong-si, Gyeonggi-do, 18478
About this study
Official title: A Prospective, Single-arm, Non-interventional, Multi-center, 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.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- Nirsevimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NirsevimabBiological
Also called Beyfortus™
Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Children up to 24 months of age who are scheduled to receive Beyfortus according to the approved indications will be selected as participants under the real-world clinical practice settings during the surveillance period. Receives: Biological: Nirsevimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Adverse Events (AEs)
Number of participants (and occurrences) experiencing AEs will be assessed.
Measured: Up to 180 days post dose
Occurence of Serious Adverse Events (SAEs)
Number of participants (and occurrences) experiencing SAEs will be assessed.
Measured: Up to 180 days post dose
Occurrence of AE of special interest (AESI)
Number of participants (and occurrences) experiencing AESI will be assessed. The definition of AESI is as follow:
- Hypersensitivity, including anaphylaxis
- Immune complex disease
- Thrombocytopenia
Measured: Up to 180 days post dose
Occurence of Adverse Drug Reaction (ADRs) as Specified in Approved Local Label
Number of participants (and occurrences) experiencing ADRs will be assessed.
Measured: Up to 180 days post dose
Occurrence of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)
Number of participants (and occurrences) experiencing RSV LRTI will be assessed.
Measured: Up to 180 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start2 Oct 2025
- Primary completion26 Sep 2029 (estimated)
- Study completion26 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200206
- Sponsor's protocol ID
- VAS00011
- Other IDs
- U1111-1316-0081
- Status last verified
- Nov 2025
- First submitted
- 29 Sep 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Non-interventional, Multi-center, Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
- ClinicalTrials.gov ID
- NCT07200206
- Acronym / sponsor ID
- VAS00011
- Conditions
- Respiratory Syncytial Virus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 26 Sep 2029 (estimated)
- Study completion
- 26 Sep 2029 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Biological: NirsevimabChildren up to 24 months of age who are scheduled to receive Beyfortus according to the approved indications will be selected as participants under the real-world clinical practice settings during the surveillance period. |
Who may qualify
- Ages
- 0 days to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children up to 24 months of age who are scheduled to receive Beyfortus according to the approved indications will be selected as participants under the real-world clinical practice settings during the surveillance period after the contract date at the institution. The participants must meet all study inclusion criteria and must not meet any of the study exclusion criteria.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NirsevimabAlso: Beyfortus™Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection | Biological | Cohort 1 |
Primary outcome
Occurence of Adverse Events (AEs)
Time frame: Up to 180 days post dose
Number of participants (and occurrences) experiencing AEs will be assessed.
Occurence of Serious Adverse Events (SAEs)
Time frame: Up to 180 days post dose
Number of participants (and occurrences) experiencing SAEs will be assessed.
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: 1. Hypersensitivity, including anaphylaxis 2. Immune complex disease 3. Thrombocytopenia
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus, run by Sanofi at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of Adverse Events (AEs) (time frame: Up to 180 days post dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.