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

Sanofi

Status and phase: Enrolling; Phase 4

Conditions: RSV Immunization

Treatments: Biological: Nirsevimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07109297

VAS00017

U1111-1310-0978 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 estimated patients

Sex: All

Ages: Under 24 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Nirsevimab

Experimental group

Description:

Participants will receive: * 1 intramuscular (IM) injection for neonates and infants aged 0 to 12 months born or entering their first RSV season at Day 01 * 2 IM injections for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season at Day 01

Treatment:

Biological: Nirsevimab