RSV InfectionsNCT07382219
Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants
An observational study of RSV Infections and Lower Respiratory Tract Infections, run by Han Tongyan at 7 sites in China.
Trial summary
A multicenter, retrospective cohort study based on clinical data from seven tertiary hospitals in China will be undertaken. The study aims to evaluate the real-world effectiveness of Nirsevimab in preventing Respiratory Syncytial Virus (RSV) infections and all-cause respiratory infections. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- RSV Infections, Lower Respiratory Tract Infections
- What is being tested?
- Nirsevimab
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 816 participants
- Where
- 7 sitesChina
- Study dates
- 1 Aug 2025to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants aged ≤ 1 year entering their first RSV season between September 2024 and April 2025
Who may be able to join
- Infants aged ≤ 1 year (including preterm infants) entering their first RSV season.
Who cannot join
- Prior or active RSV infection.
- Prior RSV immunization (maternal vaccine or monoclonal antibody).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Children's Hospital
Beijing, 100045
Peking University Third Hospital
Beijing, 100191
Beijing Luhe Hospital
Beijing, 101149
Inner Mongolia Maternity and Child Health Care Hospital
Hohhot, Inner Mongolia, 010000
Women and Children's Hospital
Qingdao, Shandong, 266000
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Shenzhen Maternity & Child Healthcare Hospital
Shenzhen, 518000
About this study
Official title: Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants: A Multicenter Cohort Study
A multicenter, retrospective cohort study based on clinical data from seven tertiary hospitals in China will be undertaken. The study aims to evaluate the real-world effectiveness of Nirsevimab in preventing Respiratory Syncytial Virus (RSV) infections and all-cause respiratory infections. Clinical records will be used to compare outcomes between infants who received Nirsevimab and a control group. The study focuses on infants aged 0 to 1 year during the RSV season.
Read the detailed description
The purpose of this study is to evaluate the effectiveness of Nirsevimab in preventing RSV-related and all-cause lower respiratory tract infections (LRTI) among infants in a real-world setting.
The target population includes infants aged 0 to 1 year enrolled across seven Chinese tertiary hospitals during the RSV season (September 2024 through April 2025). The study employs a target trial emulation design to compare infants receiving Nirsevimab with a control group of infants who did not receive Nirsevimab.
Outcomes will be assessed over a follow-up period of up to 180 days. Researchers will utilize hospital electronic medical records to identify the incidence of infections, hospitalizations, and admissions to the intensive care unit (ICU). Statistical methods, such as inverse probability of treatment weighting, will be applied to balance the characteristics of the two groups and ensure a valid comparison.
- Conditions
- RSV Infections, Lower Respiratory Tract Infections
- Being tested
- Nirsevimab
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NirsevimabBiological
Also called Beyfortus
Nirsevimab will be administered as a single intramuscular dose of 50 mg for infants < 5 kg and 100 mg for infants ≥ 5 kg.
| Study group | Role | What they receive |
|---|---|---|
| Nirsevimab group | Infants who received Nirsevimab during the study period. Receives: Biological: Nirsevimab | |
| Control group | Infants with health records established at the same study centers during the study period who were eligible for Nirsevimab but did not receive the immunization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of RSV-related LRTI hospitalization.
Number of participants admitted to the hospital (inpatient care) with a diagnosis of LRTI and a laboratory-confirmed RSV infection (detected by PCR or antigen testing).
Measured: From enrollment up to 180 days.
Secondary outcomes (1)
Incidence of all-cause LRTI hospitalization.
Number of participants admitted to the hospital with a diagnosis of LRTI caused by any pathogen (including RSV, other viruses, or bacteria) or unspecified agents.
Measured: From enrollment up to 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Aug 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionsStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 816 participants (actual)
Sponsor and investigators
- Lead sponsor
- Han Tongyan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Han Tongyan, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382219
- Sponsor's protocol ID
- M20250653
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants: A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07382219
- Acronym / sponsor ID
- M20250653
- Conditions
- RSV Infections, Lower Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- Han TongyanUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 2 Feb 2026 (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.
A multicenter, retrospective cohort study based on clinical data from seven tertiary hospitals in China will be undertaken. The study aims to evaluate the real-world effectiveness of Nirsevimab in preventing Respiratory Syncytial Virus (RSV) infections and all-cause respiratory infections. Clinical records will be used to compare outcomes between infants who received Nirsevimab and a control group. The study focuses on infants aged 0 to 1 year during the RSV season.
Detailed description
The purpose of this study is to evaluate the effectiveness of Nirsevimab in preventing RSV-related and all-cause lower respiratory tract infections (LRTI) among infants in a real-world setting.
The target population includes infants aged 0 to 1 year enrolled across seven Chinese tertiary hospitals during the RSV season (September 2024 through April 2025). The study employs a target trial emulation design to compare infants receiving Nirsevimab with a control group of infants who did not receive Nirsevimab.
Outcomes will be assessed over a follow-up period of up to 180 days. Researchers will utilize hospital electronic medical records to identify the incidence of infections, hospitalizations, and admissions to the intensive care unit (ICU). Statistical methods, such as inverse probability of treatment weighting, will be applied to balance the characteristics of the two groups and ensure a valid comparison.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nirsevimab group | – | Biological: NirsevimabInfants who received Nirsevimab during the study period. |
| Control group | – | –Infants with health records established at the same study centers during the study period who were eligible for Nirsevimab but did not receive the immunization. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants aged ≤ 1 year entering their first RSV season between September 2024 and April 2025
Key inclusion criteria (1 listed)
- Infants aged ≤ 1 year (including preterm infants) entering their first RSV season.
Key exclusion criteria (2 listed)
- Prior or active RSV infection.
- Prior RSV immunization (maternal vaccine or monoclonal antibody).
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: BeyfortusNirsevimab will be administered as a single intramuscular dose of 50 mg for infants < 5 kg and 100 mg for infants ≥ 5 kg. | Biological | Nirsevimab group |
Primary outcome
Incidence of RSV-related LRTI hospitalization.
Time frame: From enrollment up to 180 days.
Number of participants admitted to the hospital (inpatient care) with a diagnosis of LRTI and a laboratory-confirmed RSV infection (detected by PCR or antigen testing).
1 secondary outcome
Incidence of all-cause LRTI hospitalization.
Time frame: From enrollment up to 180 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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RSV
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infections and Lower Respiratory Tract Infections, run by Han Tongyan at 7 sites in China.
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 1 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: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of RSV-related LRTI hospitalization. (time frame: From enrollment up to 180 days.). 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 Feb 2026.