| CTRI Number |
CTRI/2024/09/073941 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study on the immune response and safety of an
RSV OA vaccine in India when given to older adults
60 years of age and above and adults 50‑59 years of
age at increased risk of respiratory syncytial virus
lower respiratory tract disease. |
|
Scientific Title of Study
|
A Phase 3 randomized, placebo-controlled observer blind
study in India to evaluate immune response
reactogenicity and safety of a single intramuscular
dose of RSVPreF3 OA investigational vaccine when
administered to older adults ≥60 years of age and
adults 50‑59 years of age at increased risk of
respiratory syncytial virus lower respiratory tract
disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 221265 Protocol Amendment 1 Final dated 19-Apr-24 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr. Yashpal Chugh |
| Designation |
Medical Lead-Adult Vaccines |
| Affiliation |
GSK Pharma India Private Limited |
| Address |
GSK Pharma India Private Limited C/O GlaxoSmithKline
Pharmaceuticals Limited Dr.Annie Besant Road, Worli,Mumbai
Mumbai
MAHARASHTRA
400030
India |
| Phone |
9990460200 |
| Fax |
|
| Email |
yashpal.d.chugh@gsk.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Yashpal Chugh |
| Designation |
Medical lead- Adult Vaccines |
| Affiliation |
GSK Pharma India Private Limited |
| Address |
GSK Pharma India Private Limited C/O GlaxoSmithKline
Pharmaceuticals Limited Dr.Annie Besant Road, Worli,Mumbai
Mumbai
MAHARASHTRA
400030
India |
| Phone |
9990460200 |
| Fax |
|
| Email |
yashpal.d.chugh@gsk.com |
|
Details of Contact Person
Public Query
|
| Name |
Swapnali Raut |
| Designation |
Director, Clinical Operations India |
| Affiliation |
GSK Pharma India Private Limited |
| Address |
GSK Pharma India Private Limited C/O GlaxoSmithKline
Pharmaceuticals Limited Dr.Annie Besant Road, Worli, Mumbai
Mumbai
MAHARASHTRA
400030
India |
| Phone |
9821415224 |
| Fax |
|
| Email |
swapnali.a.raut@gsk.com |
|
|
Source of Monetary or Material Support
|
| GSK India Pharma Private Limited C/o GlaxoSmithKline Pharmaceuticals Limited, Dr. Annie
Besant Road, Worli, Mumbai 400030 |
|
|
Primary Sponsor
|
| Name |
GlaxoSmithKline Biologicals SA |
| Address |
Rue De L’Institut 89
1330 Rixensart
Belgium
Zip Code - 1330 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| GSK Pharma India Private Limited |
01, Battery House Bhulabhai Desai Road Mumbai (India) 400026 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dipu TS |
Amrita Institute of Medical Sciences (AIMS) and Research Centre |
Department of Internal Medicine ,Amrita Institute of Medical Sciences (AIMS) and Research Centre, Ponekkara, Kochi, Kerala 682001
Ernakulam
KERALA |
7034028181
diputsmck@gmail.com |
| DrRG Viveki |
Belagavi Institute of Medical Science |
Department of Community Medicine, Belagavi Institute of Medical Science Belagavi,
Dr B R Ambedkar Rd, Sadashiv Nagar, Belagavi, Karnataka 590019
Belgaum
KARNATAKA |
9845143860
rgviveki@gmail.com |
| DrSonali Palkar |
Bharati Vidyapeeth (Deemed to Be University) Medical College, Hospital & Research Centre |
Pune-Satara Road, Dhankawadi, Pune- 411043, Maharashtra
Pune
MAHARASHTRA |
9881008717
palkarsh@gmail.com |
| Dr Santanu Munshi |
Calcutta School of Tropical Medicine |
Department of Clinical And Experimental Pharmacology, Calcutta School of Tropical Medicine, 108, Chittaranjan Avenue, Kolkata-700073, West Bengal, India.
Kolkata
WEST BENGAL |
9830060666
drsm03@gmail.com |
| DrDurga Krishnan |
Chettinad Hospital & Research Institute |
Chettinad Hospital & Research Institute, Rajiv Gandhi Salai Kelambakkam, Tamil Nadu,India-603103
Chennai
TAMIL NADU |
9940733645
drdurgakrishnan001@gmail.com |
| Dr Saurabh Agarwal |
Ganesh Shankar Vidyarthi Memorial (GSVM) Medical College |
Department of Medicine,Ganesh Shankar Vidyarthi Memorial (GSVM) Medical College, Department of Medicine, Swaroop Nagar, Kanpur-208002, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH |
9415039582
dragarwalsaurabh@gmail.com |
| Dr Kiran Rami |
GMERS MEDICAL COLLEGE AND CIVIL HOSPITAL |
Department of Pulmonary Medicine,GMERS MEDICAL COLLEGE AND CIVIL HOSPITAL , Sola, Ahmedabad, Gujarat 380081
Ahmadabad
GUJARAT |
9723222866
drkiranrami117@gmail.com |
| DrK Sunil Naik |
Government Medical College |
Department of Medicine,GMC & GGH, Srikakulam,Andhra Pradesh,532001
Srikakulam
ANDHRA PRADESH |
9440828299
drsunilnaikggh@gmail.com |
| Dr Mohammad Shameem |
Jawaharlal Nehru Medical College |
Department of Tuberculosis and Chest Disease,Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, UP, 202002, India
Aligarh
UTTAR PRADESH |
9412731835
mshameem@myamu.ac.in |
| Dr Anand Kawade |
KEM Hospital Research Centre |
KEM Hospital Research Centre, Vadu Rural Health Program,At Post Vadu Budruk, Taluka Shirur, District Pune 412216
Pune
MAHARASHTRA |
9552588996
anand.kawade@kemhrcvadu.org |
| Dr Dipanjan Bandyopadhyay |
North Bengal Medical College & Hospital |
Department of Medicine,North Bengal Medical College & Hospital,Sushrutanagar, Siliguri, Darjeeling-734012
Darjiling
WEST BENGAL |
8637590347
dipanjanbandyo@gmail.com |
| Dr Vinay Bhomia |
SANJIVANI SUPER SPECIALTY HOSPITAL |
Sanjivani Super Speciality Hospitals Pvt. Ltd, 1, New Uday Park Society, Near Sunrise park,Vastrapur, Ahmedabad- 380015, Gujarat, India
Ahmadabad
GUJARAT |
9825007385
drvinaybhomia@gmail.com |
| Dr Subhash Chandra Bharija |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital Marg Rajinder Nagar,
New Delhi-110060
New Delhi
DELHI |
9810068687
drscbharija@gmail.com |
| Dr Manoj Lahoti |
Suyash Hospital |
Department of Medicine,Suyash Hospital, Gudhiyari Road, Raipur- 492001, Chhattisgarh, India
Raipur
CHHATTISGARH |
9826851120
manojlahoti24@gmail.com |
| Dr Aravind GN |
Victorial Hospital Bangalore Medical College And Research |
Victorial Hospital (BMRCI), Department of Pulmonary Medicine, Fort, K.R. Road
Bangalore - 560 002, Karnataka, India
Bangalore
KARNATAKA |
9901911009
draravind80@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| CARE - Institute Human Ethics Committee for Faculty Research and Education |
Approved |
| Clinical Research Ethics Committee |
Approved |
| Ethics Committee GSVM Medical College |
Approved |
| Institutional Ethics Committe GMC |
Approved |
| Institutional Ethics Committee Bharati Vidyapeeth Deemed University |
Approved |
| Institutional Ethics Committee BIMS |
Approved |
| Institutional Ethics Committee Jawaharlal Nehru Medical College and Hospital |
Approved |
| Institutional Ethics Committee North Bengal Medical College |
Approved |
| Institutional Ethics Committee, Amrita Institute of Medical Sciences and Research Centre |
Approved |
| Institutional Ethics Committee, Ethics Committee of BMCRI |
Approved |
| Institutional Ethics Committee, GMERS Medical College and Civil Hospital Sola |
Approved |
| KEM Hospital Research Centre Ethics Committee |
Approved |
| Sanjivani Hospitals Ethics Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
| Suyash Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cohort 1: Older Adults (Male or female, ≥ 60 YOA)
Cohort 2: Male or female, 50-59 YOA at increased risk (AIR) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
NaCl (0.9%) solution
Dose- 0.5 mL,
frequency: Single dose, route of administration: Intramuscular &
total duration: Single dose |
| Intervention |
RSV PreF3 + AS01E adjuvant
(RSVPreF3 OA investigational vaccine)
|
RSV PreF3 vaccine: Powder for suspension for injection(Vial) and
AS01E adjuvant: suspension for
injection (Vial)
After reconstitution:
Dose- 0.5 mL,
frequency: Single dose, route of administration: Intramuscular &
total duration: Single dose |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants, who, in the opinion of the investigator, can and will comply with the
requirements of the protocol (e.g., completion of the eDiary, return for follow-up
visits, ability to access and utilize a phone or other electronic communications).
2.Written or witnessed informed consent obtained from the participant (participant
must be able to understand the informed consent) prior to performance of any study specific
procedure
Specific inclusion criteria for all participants in Cohort 1 (Older adults)
3.Male or female, ≥ 60 YOA at the time of the study intervention administration.
4.Participants who are medically stable in the opinion of the investigator at the time of
study intervention administration. Participants with chronic stable medical conditions
with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac
disease, are allowed to participate in this study if considered by the investigator as
medically stable.
5.Participants living in the general community or in an assisted-living facility that
provides minimal assistance can be enrolled, such that the participant is primarily
responsible for self-care and activities of daily living.
Specific inclusion criteria for all participants in Cohort 2 (Adults-AIR)
6.Male or female, 50-59 YOA at the time of the study intervention administration.
7. Participants should be diagnosed with at least 1 of the following medical conditions
and considered medically stable by the investigator:
Chronic pulmonary disease resulting in activity restricting symptoms or use of long-term medication
Chronic cardiovascular disease
Pre-existing coronary artery disease (CAD not otherwise specified)
Cardiac arrhythmia
Diabetes mellitus: type 1 or type 2 with active treatment for the last 6 months
Other diseases at increased risk for RSV-LRTD disease
8.Female participants of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy,
bilateral salpingectomy, or post-menopause.
9.Female participants of childbearing potential may be enrolled in the study if the
participant
− has practiced adequate contraception from 1 month prior to study intervention
administration, and
− has a negative pregnancy test on the day of and prior to study intervention
administration, and
− has agreed to continue adequate contraception for at least 1 month after the
study intervention administration. |
|
| ExclusionCriteria |
| Details |
1.History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including a known history of severe allergic reaction (e.g. Anaphylaxis).
2.Any confirmed or suspected immunosuppressive or immunodeficient condition, resulting from disease (e.g. current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
3.Unstable chronic illness.
4.Recurrent history or uncontrolled neurological disorders or seizures. Participants with medically-controlled active or chronic neurological diseases can be enrolled in
the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g. completion of the eDiary, attend phone call/study site visits).
5.Any history of dementia or any medical condition that moderately or severely impairs cognition.
6.Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease).
7.Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
8.Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
9.Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days (Day -29 to Day 1) before the dose of study interventions or their planned
use during the study period (Day 1 up to Month 6).
10.Previous vaccination with licensed or investigational RSV vaccine.
11.Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines (fully licensed or with emergency use
authorization [EUA]) which can be administered up to 14 days before or from 14 days after the study intervention administration.
12.Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
13.Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
14.History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
15.Participation of any study personnel or their immediate dependents, family, or household members.
16.Planned move during the study conduct that prohibits participation until study end.
17.Bedridden participants.
18.Pregnant or lactating female participant.
19.Female participant planning to become pregnant or planning to discontinue contraceptive precautions. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the humoral immune response following
administration of a single dose of the RSVPreF3 OA
investigational vaccine. |
RSV-A and RSV-B neutralizing titers pre-study
intervention administration and at 1 month after
study intervention administration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety and reactogenicity following
administration of a single dose of the RSVPreF3 OA
investigational vaccine. |
1. Occurrence of each solicited administration site
event with onset within 4 days after study
intervention administration
2.Occurrence of each solicited systemic event with
onset within 4 days after study intervention administration
3.Occurrence of unsolicited AEs within 30 days after
study intervention administration
4.Occurrence of all SAEs after study intervention
administration (Day 1) up to study end (Month 6). |
|
|
Target Sample Size
|
Total Sample Size="750"
Sample Size from India="750"
Final Enrollment numbers achieved (Total)= "750"
Final Enrollment numbers achieved (India)="751" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
27/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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 purpose of the current study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults ≥60 YOA and Indian adults 50-59 YOA at increased risk of RSV-LRTD.
RSV is a ribonucleic acid virus of the Pneumoviridae family that causes ARI in humans. There are 2 subtypes of RSV - RSV A and RSV B - circulating with other respiratory viruses. Overall, the peak activity of RSV mainly occurs during the rainy season and winter period in India, and some correlation with low temperatures has been observed. RSV causes upper and lower respiratory tract infections in people of all ages with the risk of serious infection increasing in young children, OA and adults at high-risk due to presence of comorbidities. Currently there is no treatment option or licensed vaccine in India for the prevention of RSV related LRTD in adults GSK has developed a vaccine (RSVPreF3 OA) that will protect against RSV associated LRTD in adults 60 years of age (YOA) or older and 50-59 years of age who are at increased risk for RSV disease |