| CTRI Number |
CTRI/2012/08/002909 [Registered on: 23/08/2012] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A post licensure clinical trial to evaluate the safety and tolerability of BE’s Inactivated Japanese Encephalitis Vaccine in ≥18 to ≤49 year old adult subjects in a two dose schedule. |
|
Scientific Title of Study
|
A Multicentric open label phase-IV study to evaluate safety and tolerability of BE’s inactivated vero cell derived Japanese Encephalitis vaccine in ≥18 to ≤49 year old healthy adult subjects in a two dose schedule |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT021/JEV-PIV/CTP-01 Version No:01 dated 21.10.11 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr TSA Kishore |
| Designation |
General Manager |
| Affiliation |
Biological E. Limited |
| Address |
Biological E.Limited, 18/1&3, Azamabad, Hyderabad,Andhra pradesh India
18/1&3, Azamabad,Hyderabad ANDHRA PRADESH India
500020
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214046 |
| Fax |
04027675003 |
| Email |
Kishore.tsa@biologicale.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr TSA Kishore |
| Designation |
General Manager |
| Affiliation |
Biological E. Limited |
| Address |
Biological E.Limited, 18/1&3, Azamabad, Hyderabad,Andhra pradesh India
18/1&3, Azamabad,Hyderabad ANDHRA PRADESH India
500020
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214046 |
| Fax |
04027675003 |
| Email |
Kishore.tsa@biologicale.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Shekhar Gupta |
| Designation |
Chief Operating Officer |
| Affiliation |
D2L Pharma Research Solutions |
| Address |
D2L Pharma Research Solutions 1615, 5th Main, E Block, AECS Layout, Kundalahalli, Bangalore,Karnataka,India
1615, 5th Main, E Block, AECS Layout, Kundalahalli,Bangalore, KARNATAKA,India 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
09741111101 |
| Fax |
08041534831 |
| Email |
shekhar.gupta@d2lpharma.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Biological E Limited |
| Address |
Biological E.Limited 18/1&3, Azamabad,Hyderabad,India-500020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Haridas Upadya |
Aadithya Adhikari Hospital |
Department of Medicine,Aadithya Adhikari Hospital,Contour Road, Gokulam, Mysore – 570002, Karnataka
Mysore
KARNATAKA |
09880046375
dr.upadya@gmail.com |
| Dr J Kamal Rajesh |
Andhra Hospitals |
Department of Medicine, Andhra Hospitals,CVR Complex, Prakasam Road, Vijayawada – 520002, Andhra Pradesh.
Krishna
ANDHRA PRADESH |
09573510385
kamalchytanya@gmail.com |
| Dr Shiva Kumar |
Dr. B. R. Ambedkar Medical College |
Department of Medicine,Dr. B. R. Ambedkar Medical College,Kadugondanahalli
Bangalore – 560045, Karnataka.
Bangalore
KARNATAKA |
09900329850
dr_shiva_kumar@yahoo.co.in |
| Dr K S Ashok Kumar |
Gandhi Hospital |
Department of Medicine,Gandhi Hospital
Musheerabad, Secunderabad – 500003
Andhra Pradesh.
Hyderabad
ANDHRA PRADESH |
09849174717
drksashokumar@gmail.com |
| Dr M A Shekar |
K R Hospital |
Department of Medicine, K R Hospital,Mysore Medical College
& Research Institute
Irwin Road, Mysore – 570001, Karnataka.
Mysore
KARNATAKA |
09845120106
drsheki@gmail.com |
| Dr V V Sathya Narayana |
King George Hospital |
Department of Medicine, King George Hospital (KGH), Near Collectorate Maharanipeta, Visakhapatnam - 530002, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH |
09848022894
satyanarayana.vempolu@gmail.com |
| Dr Prakash Joshi |
Sant Dnyaneshwar Medical Education & Research Centre |
Department of Medicine,Sant Dnyaneshwar Medical Education & Research Centre,Opp.Vijay Cinema, Laxmi Road
Pune – 411030, Maharashtra.
Pune
MAHARASHTRA |
09822874373
pvjoshi2001@gmail.com |
| Dr Ajit Tambolkar |
Shakuntal Nursing Home |
Department of Medicine,Shakuntal Nursing Home,384/1, Shree Shankar Chhaya Society, Shaniwar Peth, Near Suyog Mangal Karyalaya, Pune – 411030, Maharashtra.
Pune
MAHARASHTRA |
09422010172
sam_ajit2002@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Bezawada Central Ethics Committee(Andhra Hospitals) |
Approved |
| Ethics Committee Mysore Medical College and Research Institute and Associated Hospitals (K R Hospital) |
Approved |
| Human Ethics Committee (Gandhi Hospital) |
Approved |
| Independent Ethics Committee Indian Medical Association(Shakuntal Nursing Home) |
Approved |
| Institution Ethics Committee (Dr.B.R.Ambedkar Medical college and Hospital) |
Approved |
| Institutional Ethics Committee(King George Hospital) |
Approved |
| Mysore Clinical Research Ethics Committee( Aadhitya Adhikari Hospital) |
Approved |
| Mysore Clinical Research Ethics Committee( Chandrakala Hospital) |
Approved |
| Sant Dnyaneshwar Medical Education Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
For active immunization for the prevention of disease caused by Japanese encephalitis virus |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inactivated vero-cell based Japanese encephalitis vaccine of BE LTD |
6µg/0.5mL dose administered intramuscularly on 0 and 28th day |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of either sex who are between ≥18 to ≤49 years at the time of 1st vaccination
2.Written informed consent obtained prior to screening from subjects or their legally acceptable representative
3.Free of clinically significant health problems as established by medical history and physical examination before entering into the study
4.Ability of the subject or his/her legally acceptable representative to understand and comply with the requirements of the protocol
5.Negative Pregnancy test for women of child bearing potential prior to entry into the trial.
|
|
| ExclusionCriteria |
| Details |
1.Known exposure or history of any clinical manifestation of Japanese encephalitis, Dengue or yellow fever.
2.History of any previous vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever.
3.Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
4.Any family history of Immunodeficiency or autoimmune disease.
5.Administration of chronic (defined as more than 14 days) immune-suppressants or other immune-modifying drugs within 6 months of vaccination. (For corticosteroids, this meant prednisone, or equivalent, ≥0.05 mg/kg/day. Topical and inhaled steroids allowed).
6.History of severe hypersensitivity reactions (in particular to a component of the investigational vaccine, anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission).
7.Any confirmed or suspected Infection with HIV, HCV and Hepatitis B (HBsAg).
8.Subjects with history of uncontrolled diabetes, severe cardiopulmonary, hepatobiliary / renal disorders and or malignancy.
9.Any acute infection within two weeks prior to enrolment.
10.Drug addiction within 6 months prior to enrolment (including alcohol dependence, i.e. more than approx. 60 mL of alcohol per day, or conditions which might interfere with the study conduct).
11.Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects.
12.Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Solicited local and systemic adverse events (AEs)
2.Solicited and unsolicited local and systemic adverse events (AEs)captured through subject diary.
3.Solicited and unsolicited adverse events (AEs) 4.Proportion of subjects with serious and/or unexpected adverse events 5.Rate of SAEs and medically attended AEs
6.95% CI for proportion of adverse events reported |
1.During first 30 minutes of vaccine administration
2.During 7-day (Day 0-6) post vaccination period.
3.During the subsequent follow up period of 28-days after each vaccination 4.During the entire course of the study period
5.Until day 56 after the first vaccination
6.During the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinically significant changes in vital signs (Pulse, Oral body temperature, Blood Pressure and Respiratory rate) |
From baseline to day 28 and day 56 |
|
|
Target Sample Size
|
Total Sample Size="432"
Sample Size from India="432"
Final Enrollment numbers achieved (Total)= "432"
Final Enrollment numbers achieved (India)="432" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/08/2012 |
| Date of Study Completion (India) |
08/03/2013 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a multicentre single arm unblinded post licensure study to evaluate safety and tolerability of BE’s inactivated vero cell derived Japanese Encephalitis vaccine in ≥18 to ≤49 year old healthy adult subjects.This vaccine to be administered intramuscularly in two dose schedule with an interval of 28 days between doses.A total of 432 adult subjects of either gender (greater than or equal to 18 years to less than or equal to 49 years) will be enrolled.No rotuine laboratory tests will be done during this study period.This Phase-IV study is expected to provide additional safety and tolerability data on BE’s Inactivated japanese Encephalitis vaccine to meet WHO prequalification requirements. |