RSV ImmunizationPhase 4NCT07109297
Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India
A Phase 4 study testing Nirsevimab in people with RSV Immunization, run by Sanofi at 7 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- RSV Immunization
- What is being tested?
- Nirsevimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 7 sitesIndia
- Study dates
- 31 Jul 2025to 30 Jun 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Investigational Site Number : 3560002
Bengaluru, 560011
Investigational Site Number : 3560008
Jaipur, 302007
Investigational Site Number : 3560003
Kolkata, 700017
Investigational Site Number : 3560007
Nagpur, 441108
Investigational Site Number : 3560001
New Delhi, 110060
Investigational Site Number : 3560004
Pune, 411007
Investigational Site Number : 3560006
Vizianagaram, 535003
About this study
Official title: A Phase 4, Open-label, Single-arm Clinical Study to Describe Safety and Efficacy Outcomes Associated With the Use of Nirsevimab in Neonates and Infants Born During or Entering Their First Respiratory Syncytial Virus (RSV) Season and in Children up to 24 Months of Age Who Remain Vulnerable to Severe RSV Disease Through Their Second RSV Season
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.
Read the detailed 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.
- Conditions
- RSV Immunization
- Being tested
- Nirsevimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NirsevimabBiological
Also called 526, Beyfortus®
Pharmaceutical form:Sterile solution for injection-Route of administration:Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Nirsevimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of immediate adverse events (AEs)
Number of participants experiencing immediate AEs
Measured: Within 30 minutes after immunization
Presence of non-serious AEs
Number of participants experiencing non-serious AEs
Measured: From Day 01 through Day 31
Presence of adverse events of special interest (AESIs) throughout the study
Number of participants experiencing AESIs
Measured: Throughout the study (approximately 6 months)
Presence of medically attended adverse events (MAAEs) throughout the study
Number of participants experiencing MAAEs
Measured: Throughout the study (approximately 6 months)
Presence of serious adverse events (SAEs) throughout the study
Number of participants experiencing SAEs
Measured: 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
Incidence of medically attended LRTI (outpatient and inpatient) due to reverse transcription--polymerase chain reaction (RT-PCR) confirmed RSV
Measured: Through 180 days after dosing
Incidence of LRTI hospitalizations due to RT-PCR confirmed RSV through 180 days after dosing
Incidence of LRTI hospitalizations due to RT-PCR confirmed RSV through 180 days after dosing
Measured: Through 180 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start31 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV ImmunizationStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109297
- Sponsor's protocol ID
- VAS00017
- Other IDs
- U1111-1310-0978
- Status last verified
- Mar 2026
- First submitted
- 31 Jul 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org