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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nirsevimab group | Infants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nirsevimab | Biological | Nirsevimab will be administered as a single intramuscular dose of 50 mg for infants < 5 kg and 100 mg for infants ≥ 5 kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment up to 180 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment up to 180 days. |
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Inclusion Criteria:
Infants aged ≤ 1 year (including preterm infants) entering their first RSV season.
Exclusion Criteria:
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Infants aged ≤ 1 year entering their first RSV season between September 2024 and April 2025
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inner Mongolia Maternity and Child Health Care Hospital | Hohhot | Inner Mongolia | 010000 | China | ||
| Women and Children's Hospital |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000709769 | nirsevimab |
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|
| Qingdao |
| Shandong |
| 266000 |
| China |
| Beijing Children's Hospital | Beijing | 100045 | China |
| Peking University Third Hospital | Beijing | 100191 | China |
| Beijing Luhe Hospital | Beijing | 101149 | China |
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | 200092 | China |
| Shenzhen Maternity & Child Healthcare Hospital | Shenzhen | 518000 | China |
| D014777 | Virus Diseases |
| D007239 | Infections |