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

NCT07109297 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: VAS00017U1111-1310-0978
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (5)

• Presence of immediate adverse events (AEs)

  Number of participants experiencing immediate AEs

  Within 30 minutes after immunization

• Presence of non-serious AEs

  Number of participants experiencing non-serious AEs

  From Day 01 through Day 31

• Presence of adverse events of special interest (AESIs) throughout the study

  Number of participants experiencing AESIs

  Throughout the study (approximately 6 months)

• Presence of medically attended adverse events (MAAEs) throughout the study

  Number of participants experiencing MAAEs

  Throughout the study (approximately 6 months)

• Presence of serious adverse events (SAEs) throughout the study

  Number of participants experiencing SAEs

  Throughout the study (approximately 6 months)

Secondary Outcomes (2)

• Incidence of medically attended lower respiratory tract infection (LRTI) (outpatient and inpatient) due to reverse transcription--polymerase chain reaction (RT-PCR) confirmed RSV

  Through 180 days after dosing

• Incidence of LRTI hospitalizations due to RT-PCR confirmed RSV through 180 days after dosing

  Through 180 days after dosing

Study Arms (1)

Nirsevimab

EXPERIMENTAL

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

Biological: Nirsevimab

Interventions

Nirsevimab BIOLOGICAL

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

Also known as: 526, Beyfortus®

Nirsevimab

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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
• 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
• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (7)

Investigational Site Number : 3560002

Bengaluru, 560011, India

Location

Investigational Site Number : 3560008

Jaipur, 302007, India

Location

Investigational Site Number : 3560003

Kolkata, 700017, India

Location

Investigational Site Number : 3560007

Nagpur, 441108, India

Location

Investigational Site Number : 3560001

New Delhi, 110060, India

Location

Investigational Site Number : 3560004

Pune, 411007, India

Location

Investigational Site Number : 3560006

Vizianagaram, 535003, India

Location

Related Links

• VAS00017 Plain Language Results Summary

MeSH Terms

Interventions

nirsevimab

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IN (7)