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

Investigation of an Antibody for Respiratory Syncytial Virus in Young Children

Recruiting
24 months or below
All
Phase 4
110 participants needed
3 Locations

Study Overview

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.

Study Details

Study duration: up to 16 months, including 10 months of enrollment and 6 months of follow-up

  • Treatment duration: 1 day; 1 intramuscular (IM) injection
  • Visit frequency:
  • 1 in-person visit for immunization (Visit [V] 01) at Day (D) 1.
  • 3 phone call visits (V2, V3 and V4) at D31 (+ 14 days), D91 (+ 14 days) and D181 (+14 days) respectively.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: RSV Immunization
  • Age: 24 months or below
  • Gender: All

Inclusion Criteria: - Neonates and infants aged 0 to 12 months on the day of inclusion and born during or entering their first RSV season OR children up to 24 months of age on the day of inclusion who remain vulnerable to severe RSV disease through their second RSV season

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

  • Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
  • Known thrombocytopenia, as reported by the parent(s)/legally acceptable representative(s), contraindicating intramuscular injection
  • Known bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Active LRTI on the day of study intervention administration
  • Active RSV infection on the day of study intervention administration
  • Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
  • Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine in the same RSV season than inclusion in the study
  • Mother of the participant was administered an RSV vaccine during her pregnancy with the participant
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
  • Receipt of any investigational drug in the last 30 days prior to the inclusion in the study
  • Participation at the time of study enrollment or in the 4 weeks preceding the study intervention administration or planned participation during the present study period, in another clinical study investigating a vaccine, drug, medical device, or medical procedure Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

This study investigates the safety and efficacy of an investigational antibody in protecting against Respiratory Syncytial Virus (RSV) in young children. This study involves neonates and infants aged 0 to 12 months, as well as children up to 24 months of age who are vulnerable to severe RSV disease.

Participants will receive one intramuscular injection of the investigational antibody. Following the injection, there will be one in-person visit and three follow-up phone calls to monitor the participants' health and gather data on the safety and effectiveness of the treatment.

  • Who can participate: The study is open to neonates and infants aged 0 to 12 months entering their first RSV season, and children up to 24 months who are still at risk in their second RSV season. Key eligibility factors include no known hypersensitivity to the study components and no recent receipt of other RSV treatments.
  • Study details: Participants will receive a single intramuscular injection of the investigational antibody.
  • Study timelines and visits: The study will last up to 16 months. The study requires 1 visits.
Updated on 01 Oct 2025. Study ID: NCT07109297

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