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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China

NCT05110261

Lower Respiratory Tract Infection

ACTIVE_NOT_RECRUITING PHASE3

Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children

NCT04484935

RSV Infection

COMPLETED PHASE2

A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.

NCT02878330

Respiratory Syncytial Virus Infections

COMPLETED PHASE2

A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

NCT02290340

Respiratory Syncytial Virus

COMPLETED PHASE1

Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children

NCT02040831

Respiratory Syncytial Virus Infections

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

RSV Immunization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nirsevimab

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

Group Type EXPERIMENTAL

Nirsevimab

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nirsevimab

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

526 Beyfortus®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* 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.

Minimum Eligible Age

0 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes