| CTRI Number |
CTRI/2014/04/004568 [Registered on: 25/04/2014] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A post licensure label expansion study to evaluate the safety & immunogenicity of BEs Japanese Encephalitis Vaccine in ≥3 to 18 year old Indian children & adolescents in a two dose (0, 28D) schedule. |
|
Scientific Title of Study
|
An open label phase-IV, label expansion study to evaluate the safety and immunogenicity of BE’s licensed Inactivated vero cell based Japanese Encephalitis Vaccine in ≥3 to 18 year old Indian children & adolescents in a two dose (0, 28D) schedule. |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT022/JEV-PIV/CTP-02 Version No: 2.0 Dated 06.09.13 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arani Chatterjee |
| Designation |
Sr Vice President |
| Affiliation |
Biological E. Limited |
| Address |
Biological E.Limited, 18/1&3, Azamabad
Hyderabad
ANDHRA PRADESH, India
India
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214070 |
| Fax |
04027675003 |
| Email |
arani.chatterjee@biologicale.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arani Chatterjee |
| Designation |
Sr Vice President |
| Affiliation |
Biological E. Limited |
| Address |
Biological E.Limited, 18/1&3, Azamabad
Hyderabad
ANDHRA PRADESH, India
India
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214070 |
| Fax |
04027675003 |
| Email |
arani.chatterjee@biologicale.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arani Chatterjee |
| Designation |
Sr Vice President |
| Affiliation |
Biological E. Limited |
| Address |
Biological E.Limited, 18/1&3, Azamabad
Hyderabad
ANDHRA PRADESH, India
India
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04030214070 |
| Fax |
04027675003 |
| Email |
arani.chatterjee@biologicale.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Biological E Limited |
| Address |
Biological E.Limited 18/1&3,Azamabad,Hyderabad,Andhra Pradesh-500020.India |
| 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 Amlan Choudhary |
KPC Medical College |
Dept. of Pediatrics, KPC Medical College, Kolkata, 1F, Raja SC Mullick Road, Kolkata - 700032, West Bengal, India
Kolkata
WEST BENGAL |
09432909111
pedamlan1@gmail.com |
| Dr Sciddhartha Koonwar |
M.V. Hospital & Research Centre |
Dept. of Pediatrics, M.V. Hospital & Research Centre, 314/30, Mirza Mandi, Chowk, Lucknow - 226003, Uttar Pradesh, India
Lucknow
UTTAR PRADESH |
09415102691
dr_sciddhartha@indiatimes.com |
| Dr Madhukar Pandey |
Pragya Mother and Child Care Hospital |
Dept.of Pediatrics,Pragya Mother and Child Care Hospital, Plot No.9, Roshni Nagar Colony, Lanka Varanasi - 221005, Uttar Pradesh, India.
Varanasi
UTTAR PRADESH |
09839439464
pandeymadhukar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| IEC- KPC Medical College & Hospital |
Approved |
| Institutional Ethics Committee (IEC) for MV Hospital & Research Centre |
Approved |
| Swastik Bio 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 (JEEV®) of BE LTD |
6µg/0.5mL dose administered intramuscularly on 0 and 28th day |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Indian subjects of either sex between ≥3 to <18 years at the time of 1st vaccination.
2.Free from clinically significant health problems as established by medical history and protocol specified clinical laboratory tests before entering into the study as judged by the Investigator.
3.Written informed consent obtained prior to screening from subject, subject’s parent/guardian or his/her legally acceptable representative. An assent will also be obtained for children and adolescents (≥10 years to <18 years) where applicable prior to screening.
4.Ability of the subject, subject’s parent/guardian or his/her legally acceptable representative to understand and comply with the requirements of the protocol.
5.Female subjects with either no childbearing potential or, if after onset of menarche, a negative pregnancy test and a willingness to practice a reliable method of contraception.
6.Acceptable methods of birth control included barrier methods (including male and female condoms), diaphragms (cervical caps) with intra-vaginal spermicide (including jellies, foams and suppositories), intra-uterine devices, hormonal contraceptives, abstinence or same sex relationships.
|
|
| ExclusionCriteria |
| Details |
1.History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever
2.Planned administration of any other study vaccine during the study period.
3.Any family history of Immunodeficiency or autoimmune disease.
4.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).
5.Any confirmed or suspected Infection with HIV, HBV and HCV.
6.Subjects with history of severe uncontrolled diabetes/ cardiopulmonary/hepatobiliary / renal disorders and or malignancy.
7.Any acute infection within two weeks prior to enrolment.
8.Drug addiction within 3 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).
9.Pregnancy (positive urine pregnancy test during screening), lactation or unreliable contraception in female subjects after onset of menarche.
10.Subjects with 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)
3.Solicited and unsolicited adverse events (AEs)
4.Rate of SAEs and medically attended AEs
5.All safety laboratory parameters (Haematology & serum chemistry) for any clinically significant changes
6.Vital signs (Pulse, axillary/oral body temperature, Blood pressure and Respiratory rate) |
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 up to 28th day after each dose
4.Until day 56 after the first vaccination
5.From baseline to day 56
6.From baseline to subsequent visits |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number and percentage of subjects seroconverted
2.Proportion of subjects achieving ≥4-fold rise in titre
3.Geometric Mean Titres |
1.At day 56 from baseline
2.At baseline by day 56
3.At baseline and day 56 |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "108"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/06/2014 |
| Date of Study Completion (India) |
29/10/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="3" |
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 open label post licensure label expansion study to evaluate safety and immunogenicity of BE’s inactivated vero cell derived Japanese Encephalitis vaccine in ≥3 to <18 year old Indian children & adolescents. This vaccine is proposed to be administered intramuscularly in two dose schedule with an interval of 28 days between doses. A total of 108 healthy Indian children and adolescent subjects of either gender will be enrolled. All eligible subjects would be randomised equally into three age subsets, =>3 to <8 years, =>8 to <12 years and =>12 to <18 year olds. Sufficient blood sample will be drawn at baseline and again on 56th day for anti-JEV N antibody titre estimation. Routine laboratory tests will be done only twice during the study period, once at screening and again on 56th day, for hematological and biochemical parameters. Urine pregnancy will be done for women of child bearing potential at the time of screening, day 28 and at day 56. This Phase-IV study is expected to provide safety and immunogenicity data on BE’s Inactivated Japanese Encephalitis vaccine in ≥3 to <18 year old Indian children & adolescents to obtain licensure in this age subset/group as well. |