| CTRI Number |
CTRI/2024/03/063471 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to assess Safety and Immunogenicity of SII yellow fever vaccine in Adults |
|
Scientific Title of Study
|
A Phase 2/3 Multicenter, Double blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity with STAMARIL in Adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| YWF04 version 3.0 dated 17Oct2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Executive Director |
| Affiliation |
Serum Institute of India Pvt Ltd |
| Address |
second floor 212 2 Off Soli Poonawalla Road Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
02071946836 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Executive Director |
| Affiliation |
Serum Institute of India Pvt Ltd |
| Address |
second floor 212 2 Off Soli Poonawalla Road Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
02071946836 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Executive Director |
| Affiliation |
Serum Institute of India Pvt Ltd |
| Address |
second floor 212 2 Off Soli Poonawalla Road Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
02071946836 |
| Fax |
|
| Email |
drpsk@seruminstitute.com |
|
|
Source of Monetary or Material Support
|
| Serum Institute of India
212/2 Hadapsar, Off Soli Poonawalla Road, Pune-411028, India |
|
|
Primary Sponsor
|
| Name |
Dr Prasad Kulkarni MD |
| Address |
Serum Institute of India Private Limited SIIPL, 2122, Off Soli Poonawalla Road, Hadapsar, Pune - 411028, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akhil Goel |
AIIMS Jodhpur |
Room No 118 first floor B-Block OPD building department of community medicine and family medicine AIIMS Jodhpur
Jodhpur
RAJASTHAN |
9643158274
doc.akhilgoel.aiims@gmail.com |
| Dr Vineet Jain |
Hamdard Institute of Medical Sciences and Research |
B block, basement floor, department of Medicine, Guru Ravidas Marg Hamdard Nagar New Delhi 110062
New Delhi
DELHI |
9999074056
drvineet.himsr@gmail.com |
| Dr Anand Kawade |
KEM Hospital Research Centre, Vadu Rural Health Program |
ground floor, research department Vadu Budruk, Taluka Shirur, Pune 412216
Pune
MAHARASHTRA |
9552588996
anand.kawade@kemhrcvadu.org |
| Dr Varadarajulu Reginald |
Medstar Speciality Hospital |
2nd floor research department 641/17/1/3 kodigehalli Main road Sahakarnagar Bangalore
Bangalore
KARNATAKA |
9880101778
medstarclinicalresearch@gmail.com |
| Dr Ganesh Bansod |
Radiant Superspeciality Hospital |
research department, 3 floor near Kalyan Nagar Square, Sabnis Plot Amravati
Amravati
MAHARASHTRA |
9975628583
drganeshb123@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee HIMSR and associated HAH Centenary Hospital |
Approved |
| Institutional Human Ethics Committee AIIMS, Jodhpur |
Submittted/Under Review |
| KEM Hospital Research Center Ethics Committee |
Approved |
| Medstar speciality Hospital Ethics Committee |
Approved |
| Radiant Supespeciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Yellow Fever |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SII yellow fever vaccine |
dose- 0.5ml,
frequency- single dose
route of administration- subcutaneous
total duration of intervention - 1 day |
| Comparator Agent |
STAMARIL |
dose- 0.5ml,
frequency- single dose
route of administration- subcutaneous
total duration of intervention - 1 day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female volunteers aged ≥ 18 years
2. Healthy volunteers as determined by medical history and clinical examination
3. Participants willing to adhere to the protocol requirements and to provide informed consent.
4. Intend to remain residing in study area throughout study participation
5. Female participants of childbearing potential having a negative pregnancy test within 24 hours prior to IP administration and agreeing to practice
|
|
| ExclusionCriteria |
| Details |
1. Fever Axillary Temperature more than 37.5 C or any clinically significant acute infection at time of vaccination Temporary exclusion criteria participants may be reassessed for eligibility at least 48 hours after the last recorded fever
2. Previous history of infection with yellow fever, and other flaviviruses dengue fever, tick-borne-encephalitis, Japanese encephalitis, West Nile virus, zika virus, etc.
3. Previous vaccination against yellow fever, TBE, JE, or dengue fever.
4. A known hypersensitivity to any of the vaccine components (including gelatin, eggs, egg products, or chicken protein) or history of a life-threatening reaction to any past vaccine.
5. Receipt of any immunoglobulin therapy and or blood products in the past 60 days or planned administration until completion of Day 28 visit.
6. Participation in a drug research study, involving investigational products, within past 3 months or planned participation during the entire study period.
7. Receipt of any investigational or unlicensed medication (drug or vaccine) in the preceding 28 days, or planned use until completion of Day 28 visit
8. Pregnant or lactating women
9. Requirement of Yellow Fever vaccination certificate for travelling purpose
10. Major congenital or genetic defect
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate the non-inferiority between the SII-Yellow Fever vaccine and Stamaril with respect to seroconversion rates (four fold rise to baseline PRNT50 titres) post-vaccination |
PRNT50 titres will be measured at baseline pre-vaccination and post-vaccination at Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| safety, solicited and unsolicited events |
solicited till day 10 post vaccination and unsolicited day 28 post vaccination and SAE till day 180 post vaccination |
|
|
Target Sample Size
|
Total Sample Size="580"
Sample Size from India="580"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="2"
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
|
The study is designed as a multi center, double-blind, randomized clinical study to compare safety and immunogenicity of SII yellow fever vaccine with STAMARIL in healthy adults.
The participants will be screened after informed consent and those eligible will be enrolled.
A total of 580 participants will be randomized to the two groups in a ratio of 1:1 and will receive either a single dose of SII Yellow Fever Vaccine or STAMARIL via subcutaneous route.
During the entire study, a participant will have three scheduled visits – Screening, Vaccine administration on Day 0, and post-vaccination visits on Day 28 (+14), 180 (+28). |