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Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India

NCT07109297 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-03-23

No results posted yet for this study

Summary

The purpose of this study is to describe the safety and efficacy outcomes associated with the use of nirsevimab, administered as per routine clinical practice, in neonates and infants aged 0 to 12 months born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Conditions

  • RSV Immunization

Interventions

BIOLOGICAL

Nirsevimab

Pharmaceutical form:Sterile solution for injection-Route of administration:Intramuscular

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07109297 on ClinicalTrials.gov