| CTRI Number |
CTRI/2015/07/006059 [Registered on: 31/07/2015] Trial Registered Prospectively |
| Last Modified On: |
14/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to compare the immune response and safety of Chicken Pox vaccine manufactured by
Cadila Healthcare Ltd. with another Chicken Pox vaccine marketed in India in
children 1-12 years of age |
|
Scientific Title of Study
|
A prospective, randomized, single blind, parallel, active controlled, multicentre, non-inferiority clinical study to evaluate the immunogenicity and safety of Varicella vaccine (Live Attenuated, Freeze Dried IP) of M/s Cadila Healthcare Limited compared to a marketed Varicella vaccine in healthy paediatric subjects aged 1 to 12 years |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 14-11 Version No. 00 dated 21/11/14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H
ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868926 |
| Fax |
079-26868910 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H
ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868926 |
| Fax |
079-26868910 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Senior Manager – New Product Development |
| Affiliation |
Cadila Healthcare Ltd |
| Address |
Cadila Healthcare Ltd., Zydus-PTC, Sigma Commerce Zone, B/H ISCON Temple, Near Satellite Cross Roads, Ambli-Bopal Road,
Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
079-26868924 |
| Fax |
079-26868910 |
| Email |
jayeshsanmukhani@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
| Cadila Healthcare Ltd., SIGMA CommerZone Near Iscon Temple & Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad - 380015. Gujarat, INDIA. Phone No.: 079-2686-8900 Fax No.:
079-2686-8910 |
|
|
Primary Sponsor
|
| Name |
Cadila Healthcare Ltd |
| Address |
SIGMA CommerZone Near Iscon Temple & Satellite Cross Roads,
Ambli-Bopal Road, Ahmedabad - 380015. Gujarat, INDIA. Phone
No.: 079-2686-8900 Fax No.: 079-2686-8910 |
| 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 Shwetal M Bhatt |
GMERS Medical College |
Room No. 501; 5th
Floor, Department of
Paediatric, Main
Hospital Building,
GMERS Medical
College
Vadodara
GUJARAT |
9824602589
dr_Shwetal@yahoo.co.in |
| Dr Monjori Mitra |
Institute of Child Health |
Room No. 113, Ground Floor, Institute of Child Heath, 11, Dr. Biresh Guha street
Kolkata
WEST BENGAL |
9831075734
monjorimr@gmail.com |
| Dr Amlan Choudhury |
KPC Medical college & Hospital |
Department of
Pediatrics, KPC
Medical college & Hospi
tal, Jadavpur, 1H, Raja, S.C. Mullick Road
Kolkata
WEST BENGAL |
33-66211700
pedamlan1@gmail.com |
| Dr A Aparna |
Niloufer Hospital |
Department of Paediatrics, Red Hills, Lakdikapool, Hyderabad
Hyderabad
ANDHRA PRADESH |
09849418145
aparna1903@yahoo.co.in |
| Dr V K Goyal |
Panchsheel Hospital |
Department of Pediatrics Panchsheel Hospitals Private Limited, C-3/64A, Yamuna Vihar
New Delhi
DELHI |
9810106800
vkgoyal22@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee, Osmania Medical College, Koti, Hyderabad - 500059 |
Approved |
| Ethics Committee, Panchsheel Hospital Room No.1, C-3/63-A, 64-A, Opp. Gokal Puri Police Station, Yamuna Vihar, New Delhi-110053 |
Approved |
| Ethics Committee- Institute of Child Health, Dr. Biresh Guha street, Kolkata, West Bengal-700017 |
Approved |
| Institutional Ethics Committee (Institutional Review Board) GMERS Medical College Gotri, Gotri Road, Vadodara, 390021, Gujarat |
Approved |
| Institutional Ethics Committee, KPC Medical College & Hospital, Jadavpur, 1H, Raja, S.C. Mullick Road, Kolkata – 700032, West Benga |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Active immunization for the prevention of
disease caused by Varicella virus |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Varicella vaccine (Live Attenuated, Freeze-dried, IP) of M/s Cadila Healthcare Limited |
Each subject will be given a
single dose of 0.5ml vaccine
given as a subcutaneous
injection in the upper arm or in
the anterolateral aspect of the
thigh on day 0. Subjects will be
followed up for 42 days after
single dose of vaccine. |
| Comparator Agent |
Variped Vaccine Live I.P. (Oka / Merck strain), Manufactured by Merck (USA) |
Each subject will be given a
single dose of 0.5ml vaccine
given as a subcutaneous
injection in the upper arm or in
the anterolateral aspect of the
thigh on day 0. Subjects will be
followed up for 42 days after
single dose of vaccine |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy paediatric subjects of either sex aged 1 year to 12 years
2. Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child
3. Parents/guardians with adequate literacy to fill the diary cards |
|
| ExclusionCriteria |
| Details |
1. Subjects with a history of anaphylaxis or serious reactions to other vaccines, neomycin, gelatin and / or albumin
2. Subjects with a history of previous varicella infection or vaccination, or if they had been exposed to the disease within 30 days of trial commencement
3. Subjects with a history of convulsions, seizures, other central nervous system diseases, severe disease of haematopoietic system, cardiovascular system, liver or kidney
4. Subjects with an acute febrile illness at the time of randomization
5. Any other vaccine administration within 30 days of initiation of the study or planned during the study period
6. A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy)
7. Subjects who have received blood, blood products or immunoglobulins during the preceding 6 months or have planned during the study period
8. Subjects with any other clinically significant concurrent illness affecting immune response after vaccination |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the study |
42 days following vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sero-conversion rate at the end of the study for Varicella in the two groups |
42 days following vaccination |
|
|
Target Sample Size
|
Total Sample Size="256"
Sample Size from India="256"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/08/2015 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, single blind, parallel group, multicentre, non-inferiority phase II / III clinical trial to evaluate the immunogenicity and safety of Varicella vaccine (Live Attenuated, Freeze-dried, IP) of M/s Cadila Healthcare Limited compared to Variped Vaccine Live I.P. (Oka / Merck strain, Manufactured by Merck (USA) in healthy paediatric subjects aged 1-12 years. Two hundred and fifty six subjects will be randomized to receive either Varicella vaccine (Live Attenuated, Freeze-dried, IP) of M/s Cadila Healthcare Limited or Variped Vaccine Live I.P. (Oka / Merck strain, Manufactured by Merck (USA) according to the centralized computer generated randomization plan. A pre vaccination and a post vaccination (day 42) blood sample will be collected to determine IgG antibody titres to Varicella Zoster virus using gpELISA kit manufactured by The Binding Site Group Ltd, UK (VaccZymeTM). The primary efficacy end point will be the Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the study. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study. The study will be conducted in sequential manner wherein subject aged >6-12 years will be enrolled before subjects aged 1-6 years. |