Skip to content

A real-world study evaluating the effectiveness of Nirsevimab, a novel antibody drug, for preventing RSV and other respiratory infections in infants in southern China

Protection of Nirsevimab against RSV and other pathogen-induced respiratory infections in infants in (sub)tropical China: A multicenter real-world study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127159
Enrollment
Unknown
Registered
2026-06-25
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory syncytial virus (RSV)-related respiratory tract infections (including acute bronchitis, bronchiolitis, and pneumonia), all-cause respiratory infections, wheezing episodes.

Interventions

Nirsevimab exposed Group:None
Non-exposed Group:None

Sponsors

Guangzhou Women and Children's Medical Center,Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1. Term or preterm infants aged 0–1 years during the period from July 1, 2026 to June 30, 2027; 2. Have complete birth and perinatal data; 3. The legal guardian of the study subject agrees to answer the follow-up questionnaire; the study subject and their legal guardian are able to comply with all study procedures; 4. The study subject and their legal guardian are able to comply with all study procedures.

Exclusion criteria

Exclusion criteria: 1. Inability to obtain complete Nirsevimab injection records (for the injection group only); 2. Received Nirsevimab injection during the period from July 2026 to June 2027 or during the follow-up period (for the control group only); 3. Confirmed RSV infection and hospitalization prior to enrollment; 4. Severe congenital malformations; 5. Confirmed RSV infection within 7 days after enrollment; 6. Conditions deemed unsuitable for participation by the attending physician or research personnel.

Design outcomes

Primary

MeasureTime frame
RSV-related hospitalization rate;

Secondary

MeasureTime frame
ICU admission rate;Length of hospital stay;Growth development (Z-score);All-cause RTI rate;Adverse event rate;Wheezing episodes;

Countries

China

Contacts

Public ContactKeyuan Liu

Guangzhou Women and Children's Medical Center,Guangzhou Medical University

liu_keyuan@yeah.net+86 20 37103057

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026