| CTRI Number |
CTRI/2025/09/094526 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to assess the safety of Biological Es Yellow Fever vaccine in 18-45 year old people. |
|
Scientific Title of Study
|
A prospective open-label, randomized, controlled Phase-I clinical study to evaluate the safety, tolerability and reactogenicity of single dose of Biological E’s Yellow Fever Vaccine administered to 18-45 years-old healthy adults. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT093/YFV-Phase-I/CTP-02 VersionNo:2.0 dated 07.05.25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhash Thuluva |
| Designation |
Sr. Vice President- Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, Room no:5,2nd floor, Road No.35,Jubilee Hills
Hyderabad
TELANGANA
500033
India |
| Phone |
40712162478 |
| Fax |
|
| Email |
subhash.thuluva@biologicale.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Thuluva |
| Designation |
Sr. Vice President- Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, Room no:5,2nd floor, Road No.35,Jubilee Hills
TELANGANA
500033
India |
| Phone |
40712162478 |
| Fax |
|
| Email |
subhash.thuluva@biologicale.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Subba Reddy GV |
| Designation |
Associate Vice President- Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, Room no:2,2nd floor, Road No.35,Jubilee Hills
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216240 |
| Fax |
|
| Email |
subbareddy.gunneri@biologicale.com |
|
|
Source of Monetary or Material Support
|
| Biological E.Limited, 18/1&3, Azamabad, Hyderabad - 500020, Telangana, India. |
|
|
Primary Sponsor
|
| Name |
Biological E.Limited |
| Address |
Plot No 1, Phase 11, Kolthur Village, Shameerpet, Medchal-Malkajgiri District, Telangana -500 078. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shiva Narang |
GTB Hospital |
Department of General Medicine, 6th Floor, Room No::26B,Tahirpur Road, GTB Enclave, Dilshad Garden
East
DELHI |
09899838807
shivanarang@gmail.com |
| Dr Pentakota Jagath Srinivas |
King George Hospital |
Department of Community Medicine,1st Floor of OPD, Collectorate Junction, Maharani Peta - 530002
Visakhapatnam
ANDHRA PRADESH |
09949001578
pjsrinivas.kghamc@gmail.com |
| Dr A Venkateshwar Rao |
St.Theresas Hospital |
Department of Internal Medicine, Ground floor of OPD, Room no:05, Erragadda Raitu Bazar Main Road, Sanath Nagar
Hyderabad
TELANGANA |
09440040662
drvenkateshwarraoavula@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics committee, St Theresas Hospital |
Approved |
| Guru Teg Bahadur Hospital Ethics Committee |
Approved |
| IEC King George Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biological E’s Yellow Fever Vaccine |
Each 0.5 mL dose of the vaccine administered intramuscularly on Day 0 and the study duration is 28 days post vaccination. |
| Intervention |
Biological E’s Yellow Fever Vaccine |
Each 0.5 mL dose of the vaccine administered subcutaneously on Day 0 and the study duration is 28 days post vaccination. |
| Comparator Agent |
Sanofi’s Stamaril® |
Each 0.5 mL dose of the vaccine administered subcutaneously on Day 0 and the study duration is 28 days post vaccination. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Yellow Fever vaccine-naïve male and the non-pregnant, non-lactating female human volunteers aged between 18 and 45 years of age (both inclusive) at the time of vaccination.
2. Subject, in the opinion of the investigator, has ability to communicate and will comply, with the requirements of the protocol
3.Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the subject prior to performing any study specific procedure.
4. Subjects considered of stable health as judged by the principal investigator based on personal medical history, protocol specific laboratory parameters and clinical examination findings before entering into the study.
5.Subjects that are negative for Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C by laboratory testing.
6. Negative urine pregnancy test for female subjects of childbearing potential at screening.
7. Female participants of non-childbearing potential. |
|
| ExclusionCriteria |
| Details |
1.Individuals with previous history and/or existing laboratory test reports suggesting past infection by a flavivirus such as YF, tick-borne encephalitis (TBE), Japanese encephalitis virus (JE), dengue fever, or West Nile Virus (WNV).
2. Subjects with a travel history to a YF endemic area [Africa or South America including participants who plan to travel to these areas prior to completion of the study].
3. Individuals with body temperature greater than or equal to 100.4°F within 3 days of intended study vaccine administration.
4. Individuals with any progressive unstable or uncontrolled clinical conditions according to judgment of the investigator (e.g., neurological, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
5. Subject inability to understand and follow required study procedures, keep appointments, or are planning to relocate during the study period;
6. Individuals with history of any illness or any laboratory abnormality that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
7. Subject with suspected or known history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system.
8. Subject with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time or history of receipt of anti-coagulants in the past 3 weeks;
9. Individuals with a history of thymus disorders such as thymoma, myasthenia gravis, and those that are post thymectomy.
10. History of anaphylaxis, allergy, hypersensitivity or allergic reaction to any vaccine-related component; and hypersensitivity to eggs or chicken proteins;
11. Individuals participating in any other clinical trial within 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
12. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study objectives. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of subjects with solicited local and systemic adverse reactions
2. Proportion of subjects with unsolicited local and systemic adverse events (AEs)
3. Serious adverse events (SAEs) and medically attended adverse events (MAAEs) if any, |
1. During first 60 minutes of post vaccination observation period at baseline and for subsequent 10 consecutive days thereafter
2. During the total post vaccination follow up period of 28 days.
3. During the total post vaccination follow up period of 28 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Geometric mean titres (GMT) of YF neutralizing antibody levels |
At baseline, and at Day 28 |
| Proportion of subjects achieving seroconversion |
at Day 28, post single dose vaccination. |
| Proportion of subjects achieving seroprotection |
at Day 28, post single dose vaccination. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 1 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 is a prospective open-label, randomized, controlled Phase-I clinical study to evaluate the safety, tolerability and reactogenicity of single dose of Biological E’s Yellow Fever Vaccine administered to 18-45 years-old healthy adults.
A total of 90 adult subjects will be randomized 1:1:1 to either receive the investigational YF vaccine subcutaneously or intramuscularly, or a licensed comparator.
The study will be conducted in compliance with NDCT Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct. |