| CTRI Number |
CTRI/2026/03/105877 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non interventional sero-epidemiological study |
| Study Design |
Other |
|
Public Title of Study
|
Studying Immunity Against RSV (Respiratory Virus) in Adults Across India. |
|
Scientific Title of Study
|
A Multicentric, Sero-epidemiological study to assess the neutralizing antibodies titer against respiratory syncytial virus (RSV-A and RSV-B) among the adult population across India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemant Joshi |
| Designation |
Associate Director |
| Affiliation |
Cipla Ltd Vikhroli Mumbai |
| Address |
Cipla Ltd Clinical Research and Development R & D Centre North Block LBS Marg Vikhroli Mumbai, MAHARASHTRA-400083 India
Mumbai
MAHARASHTRA
400083
India
Mumbai
MAHARASHTRA
400083
India |
| Phone |
9823066463 |
| Fax |
|
| Email |
Hemant.Joshi2@Cipla.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Joshi |
| Designation |
Associate Director |
| Affiliation |
Cipla Ltd Vikhroli Mumbai |
| Address |
Cipla Ltd Clinical Research and Development R & D Centre North Block LBS Marg Vikhroli
Mumbai, MAHARASHTRA-400083
India
Mumbai
MAHARASHTRA
400083
India |
| Phone |
9823066463 |
| Fax |
|
| Email |
Hemant.Joshi2@Cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sherin Eddin |
| Designation |
Senior Manager |
| Affiliation |
Cipla Ltd Vikhroli Mumbai |
| Address |
Cipla Ltd Clinical Research and Development R & D Centre North Block LBS Marg Vikhroli Mumbai
Mumbai
MAHARASHTRA
400083
India
Mumbai
MAHARASHTRA
400083
India |
| Phone |
8422987795 |
| Fax |
|
| Email |
sherin.eddin@cipla.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Cipla Limited |
| Address |
Clinical Research and Development R and D Centre North Block LBS Marg Vikhroli West Mumbai India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dibyendu Patra |
Health Point Hospital |
OPD room no. 10, General Medicines department, 21, Prannath pandit street, Opposite of Lansdown Paddapukur, Kolkata - 700025, West Bengal, India
Kolkata
WEST BENGAL |
9432155619
dibyendu.patra@yahoo.co.in |
| Dr Ambrish C |
Medstar Speciality Hospital |
Room no. 02 Ground floor, OPD General Medicines, 641/17/1/3, Kodigehalli Main Rd, opposite Chairmans Resorts, Sahakarnagar, Bangalore-560092, Karnataka, India
Bangalore
KARNATAKA |
9845895911
drambrishmedstar@gmail.com |
| Dr Ramanbhai Gamabhai Patel |
Namostute Hospital |
Consultant room no. 105, in Department of General Medicines, Plot No. 1285, Sector-6D, GH-3 Circle, Opposite Civil Hospital, Gandhinagar-382006, India
Gandhinagar
GUJARAT |
9898205641
drramanpatel22@gmail.com |
| Dr Arnab Banerjee |
Nil Ratan Sircar Medical College |
OPD Building 2nd flood, general medicines department, 138, AJ Bose Road Kolkata-700014
Kolkata
WEST BENGAL |
9163811716
arnab.cnmc@gmail.com |
| Dr Monica Gupta |
Samvedna Hospital |
OPD No. 11, General Medicines department, B 27/884, New colony, Ravindrapi, varanasi, Uttar Pradesh- 221005, India
Varanasi
UTTAR PRADESH |
9415336322
monicag4@yahoo.com |
| Dr Animesh Choudhary |
SMC Heart Institute & IVF Research Centre |
OPD Chamber 2 General Medicines department, Infront of BSNL Office, Vidhan Sabha Road, Khamrdih, Raipur, Chhattisgarh-492007, India
Raipur
CHHATTISGARH |
7000827231
dranimeshc@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Health Point Ethics Committee |
Approved |
| Institutional Ethics Committee Nil Ratan Sircar Medical college and Hospital |
Approved |
| Institutional Ethics Committee Omega Hspital |
Approved |
| Institutional Ethics Committee – Shashvat Surgicare Hospital |
Approved |
| Medstar Speciality Hospital Ethic Committee |
Approved |
| Samvedna Hospital Ethics Committee |
Approved |
| SMC Heart Institute IEC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Respiratory syncytial virus (RSV-A and RSV-B) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.
a) Individuals aged 18-49 with any of these comorbid conditions: COPD, bronchial asthma, cardiovascular diseases and diabetes mellitus
b) Individuals age greater than or equal to 50 years irrespective of presence of comorbid conditions.
2.
Participant or legally acceptable representative (LAR) able to provide written informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Any confirmed or suspected immuno-compromised condition based on medical history and physical examination (no laboratory testing required)
2. Pregnant & lactating females or actively breast feeding.
3. Females with positive urine pregnancy test at time of screening.
4. History of vaccination against RSV
5. Recipient of blood, plasma or platelet transfusions during last 6 months
6. History of organ transplantation.
7. History lower respiratory tract infection including RSV in last 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the baseline levels of neutralizing antibodies against RSV (RSV-A And RSV-B) in overall study participants across India. |
N/A |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the baseline levels of neutralizing antibodies against RSV (RSV-A And RSV-B) in study participants by region, comorbid conditions, age & gender across India. |
N/A |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "250"
Final Enrollment numbers achieved (India)="250" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/03/2026 |
| Date of Study Completion (India) |
28/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
28/03/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study will be conducted at multiple centres across different regions of India (north, south, east, west and central). This will increase the generalizability of the findings to the broader Indian population. The study will involve collecting and analyzing blood samples (serology) to measure the levels of neutralizing antibodies against RSV-A and RSV-B. The study will assess the antibody levels at a single point in time (not longitudinally). This would provide a “snapshot” of the immune status of adults in different regions of India. This is a single visit study. Each participant will be involved for few hours on a single day during the study. All study participant related activities will be performed on one single day |