| CTRI Number |
CTRI/2011/06/001787 [Registered on: 06/06/2011] Trial Registered Prospectively |
| Last Modified On: |
21/08/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to evaluate the safety and immunogenicity of El-Shaddai Biologicals’ varicella zoster vaccine in healthy subjects aged 1 to 12 years. |
|
Scientific Title of Study
|
A phase III, multicentric, randomized single-blind study to evaluate the safety and the immunogenicity of El-Shaddai Biologicals’ varicella zoster vaccine in comparison to GlaxoSmithKline Biologicals’ Varilrix® in healthy subjects aged 1 to 12 years. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ES/VZV/01/2010 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pawan Bhusari |
| Designation |
Sr. Manager Clinical Operations |
| Affiliation |
|
| Address |
Sristek Consulting Pvt Ltd
DLF Cyber city 3rd block 8th floor gachibowli, Hyderabad
Hyderabad
ANDHRA PRADESH
500019
India |
| Phone |
04066129512 |
| Fax |
|
| Email |
pawanbhusari@sristek.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pawan Bhusari |
| Designation |
Sr. Manager Clinical Operations |
| Affiliation |
|
| Address |
Sristek Consulting Pvt Ltd
DLF Cyber city 3rd block 8th floor gachibowli, Hyderabad
Hyderabad
ANDHRA PRADESH
500019
India |
| Phone |
04066129512 |
| Fax |
|
| Email |
pawanbhusari@sristek.com |
|
Details of Contact Person
Public Query
|
| Name |
Pawan Bhusari |
| Designation |
Sr. Manager Clinical Operations |
| Affiliation |
|
| Address |
Sristek Consulting Pvt Ltd
DLF Cyber city 3rd block 8th floor gachibowli, Hyderabad
Hyderabad
ANDHRA PRADESH
500019
India |
| Phone |
04066129512 |
| Fax |
|
| Email |
pawanbhusari@sristek.com |
|
|
Source of Monetary or Material Support
|
| El Shaddai Biologicals Ltd |
|
|
Primary Sponsor
|
| Name |
El Shaddai Biologicals Ltd |
| Address |
B. Baskara Narayanan
Managing Director
old no: 7, Dr. Thirumoorthy Nagar,5th Street, Nungambakkam,
Chennai, Tamil Nadu, India - 600034
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sarika Prasad |
Aadithya Adhikari Hospital |
Aadithya Adhikari Hospital
Contour Road, Gokulam
Mysore-570002, Karnataka
Mysore
KARNATAKA |
9880692465
drsarikaprasad@gmail.com |
| DrSanjay Lalwani |
Bharatiya Vidyapeet Deemed University Hospital, Pune |
Bharatiya Vidyapeet
Deemed University Hospital, Pune Satara Road,-411 043
Pune
MAHARASHTRA |
9822051716
sanjalalwani2007@rediffmail.com |
| Dr Venugopal |
King George Hospital |
King George Hospital, Maharanipeta, Viskhapatnam-530002
Visakhapatnam
ANDHRA PRADESH |
9848027203
venugopal_kgh@yahoo.com |
| Dr Sharad Agarkhedkar |
Padmashree Dr.D.Y.Patil Pratisthan Hospital & Research Centre |
Padmashree Dr.D.Y.Patil Pratisthan Hospital & Research Centre Sant Tukaram Nagar,Pimpri-411018
Pune
Pune
MAHARASHTRA |
09822030122
ashalaka@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr.D.Y.Patil Medical College |
Approved |
| Institutional Ethics Committee, King George Hospital |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE BHARATI VIDYAPEETH DEEMED UNIVERSITY Bharati vidyapeeth Elhavan, Lar Bahadur Shastri Marg, punc-3O |
Approved |
| Mysore Clinical research |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive protection against chicken pox |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GlaxoSmithKline Biologicals’ Varilrix® |
0.5 mL/dose administered subcutaneously as a single dose to the subjects |
| Intervention |
Lyophilised live attenuated varicella vaccine (0.5 mL/dose, not less than 2000 PFU per dose of live varicella virus) |
0.5 mL/dose administered subcutaneously as a single dose to the subjects |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Indian males and females aged 1 to 12 years at the time of vaccination.
2. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
3. Subject or subject’s parent/guardian must understand and sign a written informed consent.
4. Subjects who are willing to comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) and are available for all clinic visits scheduled in the study.
|
|
| ExclusionCriteria |
| Details |
1. Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study.
2. History of hypersensitivity, convulsion, epilepsy, psychosis, thrombocytopenia, coagulation disorder, and contraindications to subcutaneous injection.
3. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
4. Individuals who have had chickenpox vaccine prior to Day 0 or documented confirmed or suspected chickenpox disease.
5. Hypersensitivity or intolerance to erythromycin and kanamycin.
6. Receipt of another investigational product within 4 weeks prior to enrollment or before completion of the safety follow-up period in this or in another study, unwilling to refuse a participation in another clinical study through the end of this study.
7. Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the trial vaccination
8. Known or suspected impairment/alteration of immune function, for example resulting from:
a. receipt of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids within 6 months prior to Visit 1
b. cancer chemotherapy
c. receipt of immunostimulants within 6 months prior to Visit 1
d. receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study
e. known HIV infection or HIV-related disease.
9. Individuals with axillary temperature ≥ 38.0°C within 3 days/on the day of intended study vaccination and/or moderate to severe acute illness/infection on the day of vaccination.
10. History of progressive or severe neurologic disorder (including Guillain-Barré syndrome and convulsions, but excluding febrile convulsions).
11. Individuals with any serious chronic or progressive disease and congenital malformation or maldevelopment according to judgment of the investigator (including, but not limited to neoplasm, insulin dependent diabetes, cardiac, renal, hepatic or respiratory disease, Down’s syndrome).
12. Bleeding diathesis.
13. Suffering from serious dermatoses (such as allergy, herpes, suppuration and fungal infection.
14. Planned surgery during the study period that in the Investigator’s opinion would interfere with the study visits schedule.
15. Relatives of research staff (The families of the site staff who are not involved in this trial are allowed their participation to this trial).
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of subjects achieving seroconversion (defined as rise in post vaccination test value in comparison with pre vaccination) |
At day 42 to 47, in comparison to baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of subjects with test value less than 0.60.
Percentage of subjects with test value greater than or equal to 0.60 to less than or equal to 0.90.
Percentage of subjects with test value greater than or equal to 0.90.
|
At day 42 to 47, in comparison to baseline |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2011 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to compare immunogenicity
and safety of El-Shaddai
Biologicals’ lyophilised live attenuated varicella zoster vaccine with
GlaxoSmithKline Biologicals’ Varilrix® in healthy subjects aged 1 to
12 years. Objectives
1. To assess the immunogenicity of the
lyophilised live attenuated varicella vaccine in comparison to Varilrix® in
healthy subjects.
2. To assess the safety of the
lyophilised live attenuated varicella vaccine in comparison to Varilrix®
in healthy subjects.
|