| CTRI Number |
CTRI/2013/05/003611 [Registered on: 06/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
03/05/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Phase III study for evaluation of safety and efficacy of Varicella vaccine. |
|
Scientific Title of Study
|
An Open label, Phase III, Multicentric Randomized controlled study to evaluate the safety and immunogenicity of Single dose Live Attenuated Varicella Vaccine (VR 795 varicella Oka strain) versus Varilrix Vaccine in healthy Indian children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WOC/VAC/VAR/CT – 19 – PRT |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema Bawangade |
| Designation |
Asst. manager - Medical Affairs |
| Affiliation |
Wockhardt Limited |
| Address |
Wockhardt Limited
Wockhardt Towers,
Bandra - Kurla Complex,
Bandra (East) - Mumbai
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
|
| Fax |
|
| Email |
SBawangade@wockhardt.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Seema Bawangade |
| Designation |
Asst. manager - Medical Affairs |
| Affiliation |
|
| Address |
Wockhardt Limited
Wockhardt Towers,
Bandra - Kurla Complex,
Bandra (East) - Mumbai
MAHARASHTRA
400 051
India |
| Phone |
|
| Fax |
|
| Email |
SBawangade@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Seema Bawangade |
| Designation |
Asst. manager - Medical Affairs |
| Affiliation |
|
| Address |
Wockhardt Limited
Wockhardt Towers,
Bandra - Kurla Complex,
Bandra (East) - Mumbai
MAHARASHTRA
400 051
India |
| Phone |
|
| Fax |
|
| Email |
SBawangade@wockhardt.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Wockhardt Limited |
| Address |
Wockhardt Limited, Wockhardt Towers, Bandra – Kurla Complex, Bandra East, Mumbai 400 051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raju Shah |
Ankur Children Hospital, Amedabad |
Department of pediatrics Ankur Children Hospital
Behind City Gold Cinema, Ashram Road Navarangpura, Amedabad, Gujarat
Ahmadabad
GUJARAT |
09824031851
rajucshah@rediffmail.com |
| Dr Apurba Ghosh |
Institute of Child Health |
Department of pediatrics
11 Biresh Guha Road, Kolkata 700017
Kolkata
WEST BENGAL |
03322812084
apurbaghosh@yahoo.com |
| Dr Nitin Shah |
Lions Tara Chand Bapa Hospital, Mumbai |
Department of Pediatrics
Lions Tara Chand Bapa Hospital, Sion (West), Mumbai: 400022
Mumbai
MAHARASHTRA |
09821037201
drnitinshah@hotmail.com |
| Prof MMA Faridi |
University College of Medical Sciences & GTB Hospital |
Professor Department of Paediatrics
University College of Medical Sciences & GTB Hospital Dilshad Garden, East Delhi, New Delhi – 110095
New Delhi
DELHI |
01122586262
drmmafaridi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Academic & Ethical Committee GTB Delhi Dr MMA Faridi |
Approved |
| Aditya IEC - Ahmedabad Dr Nitin Shah |
Approved |
| Aditya IEC - Ahmedabad Dr Raju Shah |
Approved |
| EC ICH Kolkata Dr Apurba Ghosh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
seronegative for Varicella Zoster Virus IgG antibody |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Single dose Live Attenuated Varicella Vaccine (VR 795 varicella Oka strain)of Wockhardt Limited |
Live attenuated Varicella Vaccine VR 795 Varicella Oka strain. Single dose of 0.5 ml of reconstituted vaccine given subcutaneously. |
| Comparator Agent |
VARILRIX
Manufactured by GSK. |
VARILRIX, a commercially approved live weakened varicella-zoster virus (Oka strain) manufactured by GSK.
Single dose of 0.5ml varilrix vaccine given subcutaneously
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
• Healthy children aged 12 months to 12 years of either sex who are baseline VZV IgG antibody negative
• Parent/guardian of subject willing to give written informed consent and to comply to all study related procedures
|
|
| ExclusionCriteria |
| Details |
• Clinical history of varicella (chicken pox) and herpes zoster natural infection in the past.
• History of Varicalla vaccination in the past.
• History of household, playmate, school or daycare center exposure to varicella or herpes zoster in the previous 4 weeks prior to vaccination
• Presence of any person in close vicinity of the vaccine who is at high risk of developing varicella (like immunocompromised sibling)
• Any established or clinically suspected immunosuppressive or immunocompromised disorder / state (congenital or acquired- drug induced, neoplastic, tuberculosis etc)
• Any subject who had received parenteral immunoglobulin or any immunosuppressive drugs in the last three months.
• Any major congenital abnormality – cardiac, renal, neurological
• Any acute dermatological disease such as, allergy and bacterial/viral/ fungal infection
• Participant on any dose of oral/parenteral steroids or inhalational steroids >800 mcg of beclomethasone (or its equivalent) in the last 3 months prior to vaccination.
• History of any allergic diatheses and those with known hypersensitivity to vaccine or any of its components like gelatin, gentamicin / neomycin/ kanamycin etc.
• Febrile (axillary temperature > 37°C) or any systemic illness at the time of vaccination.
• History of administration of varicella zoster immune globulin or any blood products in the previous 4 weeks
• Subject has received any live vaccine in the last 4 weeks or any killed vaccine in the last 4 weeks prior to this scheduled vaccination.
• Subject scheduled to be administered a live vaccine in the next 4 weeks or any killed vaccine in the next 4 weeks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The immunogenicity profile of the test will be evaluated and compared with that of the reference (Varilrix) vaccine in the study population by estimation of the:
a) Seroconversion rates amongst those who were baseline seronegative for IgG VZV antibody (i.e 100mIU/ml) and had a 6 weeks post-vaccination ELISA varicella IgG antibody level of ( 150mIU/ml)
b) Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination
|
a. Seroconversion rates amongst those who were baseline seronegative for IgG VZV antibody (i.e 100mIU/ml) and had a 6 weeks post-vaccination ELISA varicella IgG antibody level of ( 150mIU/ml)
b. Extent of rise of Varicella (VZV) IgG antibody from baseline values at 6 weeks post vaccination
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The safety of the vaccine in the study population will be evaluated by estimation of incidence of both serious and non-serious adverse events upto 6 weeks post vaccination with an intensive initial monitoring phase of 10 days post vaccination |
estimation of incidence of both serious and non-serious adverse events |
|
|
Target Sample Size
|
Total Sample Size="254"
Sample Size from India="254"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/09/2012 |
| 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)
|
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 an An open label, Phase III, Multicentric, randomized
controlled study to evaluate the safety and immunogenicity of Single dose Live
Attenuated Varicella Vaccine (VR 795 of varicella Oka strain) Versus Varilrix
Vaccine in healthy Indian children. There will be 268 subjects to be enrolled
(134 in each arm) in this trial. THe objective of this trial is Comparative assessment
of the immunogenicity of the test vaccine versus the comparator by estimation of:
a)
Seroconversion rates in each
treatment arm at 6 weeks post vaccination.
b)
Extent of rise of Varicella
(VZV) IgG antibody from baseline values at 6 weeks post vaccination.
And comparative
assessment of safety and tolerability of the vaccine up to 6 weeks post
vaccination
|