| CTRI Number |
CTRI/2016/11/007452 [Registered on: 08/11/2016] Trial Registered Prospectively |
| Last Modified On: |
08/11/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study to evaluate the immune response and safety of double dose of live attenuated Chicken Pox vaccine among Indian children : 12 month follow up study |
|
Scientific Title of Study
|
Evaluation of Immunogenicity, safety and breakthrough infection of 2-doses of Live Attenuated Varicella Vaccine in Indian Children: 12 months follow up study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monjori Mitra |
| Designation |
Associate Professor |
| Affiliation |
Institute of Child Health, |
| Address |
Institute of Child Health,
Address: 11, Biresh Guha Road, Kolkata- 700017
Kolkata
WEST BENGAL
kolkata-700017
India |
| Phone |
9831075734 |
| Fax |
|
| Email |
monjorimr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monjori Mitra |
| Designation |
Associate Professor |
| Affiliation |
Institute of Child Health, |
| Address |
Institute of Child Health,
Address: 11, Biresh Guha Road, Kolkata- 700017
Kolkata
WEST BENGAL
kolkata-700017
India |
| Phone |
9831075734 |
| Fax |
|
| Email |
monjorimr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monjori Mitra |
| Designation |
Associate Professor |
| Affiliation |
Institute of Child Health, |
| Address |
Institute of Child Health,
Address: 11, Biresh Guha Road, Kolkata- 700017
Kolkata
WEST BENGAL
kolkata-700017
India |
| Phone |
9831075734 |
| Fax |
|
| Email |
monjorimr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Ltd, Wockhardt Towers, Bandra Kurla Complex, Bandra (East) Mumbai – 400051 |
|
|
Primary Sponsor
|
| Name |
Wockhardt Ltd |
| Address |
Wockhardt Towers, Bandra Kurla Complex, Bandra (East) Mumbai – 400051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monjori Mitra |
Institute of Child Health, |
Address: 11, Biresh Guha Road, Kolkata- 700017
Room No-113 Project room, Ground floor
Kolkata
WEST BENGAL |
9831075734
22893242
monjorimr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Institute of child Health |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Indian children in the age group ≥ 12 months but ≤12 years of either gender |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIOVAC VTM |
BIOVAC VTM Varicella vaccine (live attenuated) I.P. Freeze dried 0.5ml/vial marketed by Wockhardt Limited, Mumbai containing Oka strain. After reconstitution each 0.5ml/dose varicella not less than 3.4 Lg PFU of the Oka strain of the varicella virus.
Immediately after reconstitution with sterile water for injection as per the manufacturer’s instructions - 0.5 ml dose of the vaccine, will be injected by subcutaneous route at deltoid insertion area of the lateral upper arm.
Second dose of the vaccine to be injected similarly at 3 months interval after the first dose.
The vaccine shall be stored as per the manufacturer’s instructions.
|
| Comparator Agent |
None |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
12.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects aged ≥ 12 months but ≤12 years of either sex.
2.No clinical history of varicella (chicken pox) and herpes zoster natural infection in the past.
3.With an axillary temperature ≤37.5°C at the time of vaccination
4.No varicella vaccination history previously.
5.Parent or the legal guardian of the subject should provide written informed consent.
6.Parent or the legal guardian of the subject should agree to comply with all trial related instructions (maintain diary card, attend follow up visits)
|
|
| ExclusionCriteria |
| Details |
1.Clinical history of varicella (chicken pox) and herpes zoster natural infection in the past.
2.History of household, playmate, school or daycare center exposure to varicella or herpes zoster in the previous 4 weeks prior to vaccination.
3.Presence of any person in close vicinity of the subject who is at high risk of developing varicella (like immunocompromised sibling)
4.Any established or clinically suspected immunosuppressive or immunocompromised disorder / state (congenital or acquired- drug induced, neoplastic, tuberculosis etc.)
5.Any subject who had received parenteral immunoglobulin or any immunosuppressive drugs in the last three months.
6.Any major congenital abnormality – cardiac, renal, neurological.
7.Any acute dermatological disease such as, allergy and bacterial/viral/ fungal infection.
8.History of encephalopathy, epilepsy and other nervous system disorders.
9.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.
10.History of any allergic diatheses and those with known hypersensitivity to vaccine or any of its components like gelatin, gentamicin / neomycin/ kanamycin etc.
11.Febrile (axillary temperature > 37.5°C) or any systemic illness at the time of vaccination.
12.History of administration of Varicella zoster immune globulin or any blood products in the previous 4 weeks.
13.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.
14.Subject scheduled to be administered a live vaccine in the next 4 weeks or any killed vaccine in the next 4 weeks.
15.Participation in any other interventional clinical trial.
16.Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Assessment of immunogenicity of two doses of the vaccine by estimation of seroprotection rates, considering a cut-off of 5gpELISA or 10 mIU/ml of anti-Varicella (VZV) IgG antibody and the rise of geometric mean titer (GMT) from baseline values to four weeks after the 1st and 2nd dose vaccination respectively. |
Each enrolled subject shall be followed up to 12 months post vaccination. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of "Breakthrough" infections of varicella occurring post vaccination (from 42 days after 1st and 2nd dose of vaccine to study end i.e. up to 12 months).
2. Assessment of safety by monitoring for solicited and unsolicited vaccine related serious and non-serious adverse effects from first dose vaccination to 6 weeks of second dose post vaccination.
|
Each enrolled subject shall be followed up to 12 months post vaccination |
|
|
Target Sample Size
|
Total Sample Size="305"
Sample Size from India="305"
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 4 |
|
Date of First Enrollment (India)
|
21/11/2016 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Varicella is a highly infectious disease caused by the Varicella zoster virus (VZV). Secondary attack rates for this virus might reach 90% for susceptible household contacts. VZV causes a systemic infection that results typically in lifetime immunity. In otherwise healthy persons, clinical illness after re-exposure is rare. Overall Study design & Plan: The study will be an Open level single arm study to evaluate the immunogenicity & safety of double dose live attenuated varicella Vaccine in healthy Indian children. This investigator-initiated trial proposes to evaluate the immunogenicity, safety and to estimate the incidence of "Breakthrough" infections of varicella occurring post vaccination with two dose schedule with three months interval. Since there is paucity of published data from India in this field, the long term objectives of the study will be to evaluate the incidence of breakthrough infection and the trend of antibody titre upto 12 months post-vaccination. Total Population- 305 healthy children in the age group ≥ 12 months but ≤12 years. Each enrolled subject shall be followed up to 12 months post vaccination |