| CTRI Number |
CTRI/2025/11/098082 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to understand safety of Palivizumab in Children of Less Than 24 Months of Age With High Risk of developing Respiratory Syncytial Virus (RSV) Disease |
|
Scientific Title of Study
|
A Multicentre, Interventional, Phase IV, Open-label, Study to Evaluate the Safety of Palivizumab in Children Less than 24 Months of Age With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D4800L00014 Version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suresh Kumar Panuganti |
| Designation |
Head of Department- Paediatric Critical Care |
| Affiliation |
Yashoda Hospital Somajiguda |
| Address |
3rd floor Room no 320
Yashoda Healthcare Services Limited
Raj Bhavan road Somajiguda Hyderabad India
Hyderabad
TELANGANA
500082
India |
| Phone |
7995900703 |
| Fax |
|
| Email |
drskpanuganti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gagandeep Momi |
| Designation |
Therapy Area Lead-BBU |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore Karnataka India 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9205074255 |
| Fax |
|
| Email |
gagandeep.momi@astrazeneca.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr V V Niranjan Kumar |
| Designation |
Project Manager |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore Karnataka India 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
6281750951 |
| Fax |
|
| Email |
v.vniranjankumar@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca Pharma India Ltd
Corporate & Registered Office Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore Karnataka India 560045 |
|
|
Primary Sponsor
|
| Name |
AstraZeneca Pharma India Ltd |
| Address |
Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore Karnataka India – 560045 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Urmila Dahake |
All India Institute of Medical Science |
All India Institute of Medical Science Mihan Nagpur Maharashtra 441108 India
Nagpur
MAHARASHTRA |
9881150353
drurmilachauhan@aiimsnagpur.edu.in |
| Dr VINAY BAJPAI |
Atmaram Child Care and Critical Care Kanpur |
Atmaram Child Care and Critical Care 128 by 53 Y Block Naubasta Kanpur Uttar Pradesh 208011
Kanpur Nagar
UTTAR PRADESH |
9792777740
vinay.bajpai31@gmail.com |
| Dr Pradeep Nanjappa |
Cheluvamba Hospital Mysore Medical College and Research Institute |
Cheluvamba Hospital Opp Mysore Medical College and Research Institute Irwin road Mysore Karnataka 570001 India
Mysore
KARNATAKA |
9611898080
drpradeepn80@gmail.com |
| Dr Vinod H Ratageri |
Karnataka Medical College and Research Institute |
Karnataka Medical College and Research Institute Old PB Road Vidyanagar Hubballi Karnataka 580022 India
Dharwad
KARNATAKA |
9448278480
ratageri@rediffmail.com |
| Dr Kalpana Dutta |
Medical College and Hospital |
88 College Street, KOLKATA - 700073
Kolkata
WEST BENGAL |
9836424144
drkalpanadatta@gmail.com |
| Dr Om Shankar Chaurasiya |
MLB Medical College |
MLB Medical College Kanpur Road Jhansi Uttar Pradesh 284128 India
Jhansi
UTTAR PRADESH |
9532376316
chaurasiyaom@gmail.com |
| Dr Bhupendra Chande |
New Health City Hospital |
New Health City Hospital Panchvati Towers Wardha Road Beside Hitvada Head Office Dhantoli Nagpur Maharashtra 440012 vIndia
Nagpur
MAHARASHTRA |
9820454695
bhupendra_chande@yahoo.com |
| Dr Pradeep Suryawanshi |
Sahyadri Super Speciality Hospital |
Survey No. 185A Shastri Nagar Near MSEB Office Yerwada Nagar Road Pune 411028 Maharashtra India
Pune
MAHARASHTRA |
9923540500
drpradeepsuryawanshi@gmail.com |
| Dr Pankaj Garg |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital Old Rajinder Nagar New Delhi 110060 India
New Delhi
DELHI |
9810146581
pankajgarg69@gmail.com |
| Dr Akash Sharma |
Surya Hospital |
Surya Childrens Medicare Pvt Ltd
Gate No 1 B7 Sawai Ram Singh Road Tonk Road
Opposite SMS Hospital C Scheme Jaipur Rajasthan 302001
Jaipur
RAJASTHAN |
9887248273
drakash.jpr@gmail.com |
| Dr Suresh Kumar Panuganti |
Yashoda Hospital |
Yashoda Healthcare Services Limited
Clinical Research department Haritha apartments 4th floor 401 Raj bhavan road Somajiguda Hyderabad-500082 Telangana India
Hyderabad
TELANGANA |
7995900703
drskpanuganti@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee Atmaram Child Care And Critical Care |
Approved |
| Ethics Committee M L B Medical College |
Approved |
| IEC MMC and Research Institute and Associated Hospital |
Approved |
| IEC, Maharaja Agrasen Superspecialty Hospital, |
Approved |
| Institutional Ethics Committee for Human Research |
Approved |
| Intitutional Ethics Committee for Clinical Trial |
Approved |
| KMCRI Ethics Committee |
Approved |
| Sahyadri Hospitals Pvt Ltd Ethics Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
| Triveni Polyclinic Institutional Ethics Committee |
Approved |
| Yashoda Academy of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J121||Respiratory syncytial virus pneumonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Palivizumab (Synagis™) |
Palivizumab (Synagis™) is administered as a 15 mg/kg intramuscular injection every month for up to 5 doses in infants and children under 24 months of age who are at high risk of severe RSV disease No comparator arm is included as this is an open-label single-arm post-marketing Phase IV safety study |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
23.00 Month(s) |
| Gender |
Both |
| Details |
Infants born greater than equal to 35 wGA and are less than 6 months of age at enrolment
Children less than 24 months of age at enrolment and requiring treatment for BPD within the last 6 months
Children less than 24 months of age and with haemodynamically significant CHD
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Hospitalisation at the time of enrolment unless the discharge is expected within 30 days of the time of enrolment
Required mechanical ventilation including continuous positive airway pressure or other mechanical respiratory or cardiac support at the time of enrolment
Anticipated cardiac surgery within 2 weeks after enrolment
Anticipated survival of greater than 6 months after enrolment in the trial
Active LRTD including RSV infection at the time of enrolment and or study intervention administration
Any fever greater than or equal to 38 degree Celsius or acute illness within 7 days prior to investigational product administration
Known history of evolving or unstable neurologic disorder
Known history of unstable cardiac or respiratory status including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated
Known allergy including to immunoglobulin products or history of allergic reaction
Prior or Concurrent Clinical Study Experience
Receipt of palivizumab or other RSV monoclonal antibodies or any RSV vaccine including maternal RSV vaccination
Receipt of any monoclonal or polyclonal antibody for example hepatitis B immune globulin intravenous immunoglobulin or anticipated use during the study
Concurrent enrolment in another interventional study
Other Exclusions
Children of employees of the sponsor clinical study site or any other individuals involved with the conduct of the study or immediate family members of such individuals
Judgment by the investigator that the participant should not participate in the study if the participant or the participants parent or legal guardian is unlikely to comply with study procedures restrictions and requirements |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the Safety of palivizumab by the estimation of occurrence of all AEs and SAEs |
Day 1 Visit 1
day 31 Visit 2
day 61 Visit 3
day 91 visit 4
day 121 visit 5
day 151 visit 6
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
10/12/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This Phase IV, open-label, multicenter study aims to
evaluate the safety of palivizumab (SYNAGIS) in preventing severe respiratory
syncytial virus (RSV)-related lower respiratory tract disease in high-risk
infants and children in India. The study plans to enroll 138 participants, who
will receive monthly intramuscular injections of palivizumab (15 mg/kg) for up
to five doses during the RSV season. Participants undergoing cardiac surgery
with cardiopulmonary bypass may receive an additional dose post-surgery once
medically stable. Safety assessments will be conducted prior to each dose, and
a follow-up will be performed telephonically 30 days after the final injection.
The study is designed to monitor the overall safety profile of palivizumab in
the target population, with timelines for first enrollment and study completion
yet to be finalized |