| CTRI Number |
CTRI/2025/05/087740 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of monoclonal antibody nirsevimab against Respiratory Syncytial Virus (RSV) in participants up to 24 months of age in India. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1310-0978 |
UTN |
| VAS00017 Protocol Version 2.0 dated 11 Feb 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Godhuli Chatterjee |
| Designation |
Medical Advisor |
| Affiliation |
Sanofi India Limited (SIL) |
| Address |
Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki
Vihar Road, Powai, Mumbai
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
919930151289 |
| Fax |
|
| Email |
Godhuli.Chatterjee@sanofi.com |
|
Details of Contact Person
Public Query
|
| Name |
Vibhawari Waghanna |
| Designation |
Clinical Project Leader |
| Affiliation |
Sanofi India Limited (SIL) |
| Address |
Sanofi House, C.T.S. No. 117/B, L&T Business Park, Saki
Vihar Road, Powai
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
917045402595 |
| Fax |
|
| Email |
Vibhawari.Waghanna@sanofi.com |
|
|
Source of Monetary or Material Support
|
| Sanofi Winthrop Industrie (SWI)
14 Espace Henry Vallée, 69007 Lyon, France |
|
|
Primary Sponsor
|
| Name |
Sanofi Healthcare India Pvt Ltd |
| Address |
Sanofi House, CT Survey No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai 400072 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meenakshi Girish |
All India Institute of Medical Sciences, Nagpur |
Department of Pediatrics,
MIHAN, Nagpur Nagpur Nagpur
Maharashtra - 441108
Nagpur
MAHARASHTRA |
9823084604
meenakshimgirish@gmail.com |
| Dr Kishore Kumar |
Cloudnine Hospital |
#1533, 9th main, 3rd block, Department of Neonatology, Jayanagar, Bengaluru – 560011
Bangalore
KARNATAKA |
9900155001
drkishore@cloudninecare.com |
| Dr Jaydeep Choudhary |
Institute of Child health |
Department of Pediatrics, 11, Dr. Biresh Guha street, Park Circus, Ballygunge, Kolkata 700017
Kolkata
WEST BENGAL |
9831191020
drjaydeep_choudhury@yahoo.co.in |
| Dr Rapaka Sujatha Devi |
Maharani Ghosha Hospital and Government Medical college |
Vizianagaram 535003, Andra Pradesh
Vizianagaram
ANDHRA PRADESH |
9490494236
drsujathadeviresearch@gmail.com |
| Dr Pramod Jog |
Medipoint Hospital Pvt. Ltd. |
Department of Pediatrics
241/1, New D. P. Road, Aundh, Pune-411007
Pune
MAHARASHTRA |
9422309677
drpramod.medipoint@gmail.com |
| Dr Pankaj Garg |
Sir Ganga Ram Hospital |
Department of Neonatology, Sir Ganga Ram Hospital marg, Rajendra Nagar, New Delhi – 110060
New Delhi
DELHI |
9810146581
pankajgarg69@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| IEC- Government Medical College,Government Medical College,Contonment Vizianagaram |
Approved |
| Institutional Ethics Committee for Clinical Trial |
Approved |
| Institutional Ethics Committee ICH-Kolkata |
Submittted/Under Review |
| Institutional Ethics Committee- Cloudnine Hospital |
Submittted/Under Review |
| Penta-Med Ethics Committee-Pune |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Infants and children up to 24 months of age. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Nirsevimab |
-IM injection for neonates and infants aged 0 to 12 months born or entering their first RSV season (50 mg if weight less than 5 kg; 100 mg if weight more than equal to 5 kg)
- 2 IM injections (2x100 mg) for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
- 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.
- Informed consent form has been signed and dated by the participant’s parent(s) or other legally acceptable representative(s).
- Participant and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and to comply with all study procedures |
|
| ExclusionCriteria |
| Details |
- 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 substances9
- 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 more than equal to 38.0°C [more than equal to 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.
- Being in an emergency setting.
- Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study.
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of participant safety or study results.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To describe the safety outcomes associated with the use of nirsevimab injection in neonates and infants 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. |
181 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To describe the occurrence of medically attended RSV lower respiratory tract infection (LRTI) in neonates and infants
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.
To describe the occurrence of RSV LRTI hospitalization in neonates and infants 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. |
180 days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
he 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 include:
• Study duration: up to 16
months, including 10 months of enrollment and 6 months of follow-up
• Treatment duration: 1 day;
1 or 2 IM injections
• Visit frequency:
1 in-person visit for
immunization (V1) at D01.
3 phone call visits (V2, V3
and V4) at D31 (+ 14 days), D91 (+ 14 days) and D181(+ 14 days) respectively.
Additional LRTI visits may
occur during the study in case of LRTI symptoms. All participants seeking
medical attention for a respiratory illness (in either the inpatient or outpatient
setting) will be evaluated for the occurrence of LRTI.
Parents/LARs will inform the
site if the participant experiences any LRTI symptoms. The site staff should
verify information on LRTI symptoms and, if an RSV-LRTI is suspected, schedule
an appointment for a nasal swab as soon as possible and preferably within 2
days of the initial healthcare provider assessment.
In that case, an LRTI visit
form will be completed in the
eCRF and information
on clinical manifestations, including respiratory symptoms and fever will be
collected. |