| CTRI Number |
CTRI/2024/06/068581 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate the efficacy and safety of varicella vaccine in healthy pediatric population. |
|
Scientific Title of Study
|
A Prospective, Randomized, Single Blind, Parallel, Active Controlled,
Multicentre, Non-Inferiority Phase III Study to Evaluate The Immunogenicity
And Safety Of Live Attenuated Varicella Vaccine Of Sinovac Biotech Ltd,
China Compared To VARIPED® Vaccine (Varicella Vaccine Live I.P By MSD
Pharmaceuticals Pvt Ltd, India) In Healthy Paediatric Subjects In India |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRN_3110/2021 Version No. 2.0 Dated 24 Nov 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hari Shanker Joshi |
| Designation |
Professor & Head Department of Community Medicine & Family Medicine |
| Affiliation |
All India Institute of Medical Sciences Gorakhpur |
| Address |
2nd Floor, Academic Block
All India Institute of Medical Sciences, Kunraghat
UTTAR PRADESH
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9415833751 |
| Fax |
|
| Email |
drjoshiharish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Singh |
| Designation |
Head Clinical operations |
| Affiliation |
Clinical Research Network India |
| Address |
B-806-807, Advant Navis Business Park, Plot#7, Noida-Greater Noida Expressway, Sector 142, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201305
India |
| Phone |
9695237796 |
| Fax |
|
| Email |
nidhisingh@crnindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Singh |
| Designation |
Head Clinical operations |
| Affiliation |
Clinical Research Network India |
| Address |
B-806-807, Advant Navis Business Park, Plot#7, Noida-Greater Noida Expressway, Sector 142, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201305
India |
| Phone |
9695237796 |
| Fax |
|
| Email |
nidhisingh@crnindia.org |
|
|
Source of Monetary or Material Support
|
| Techinvention Lifecare Pvt Ltd
|
|
|
Primary Sponsor
|
| Name |
Techinvention Lifecare Pvt Ltd |
| Address |
1004, The summit business park, Off WEH metro station, Andheri kurla road Andheri east Mumbai 400093. INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Clinical Research Network India CRO |
B-806-807, Advant Navis Business Park, Plot #7,
Noida-Greater Noida Expressway, Sector 142,
Noida, Delhi-NCR, Uttar Pradesh 201305
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Pandey |
All India Institute of Medical Sciences |
Dept. of Community & Family Medicine, All India Institute of Medical Sciences,Phulwari sarif,
Patna
BIHAR |
7783892746
drsanjaypandey43@gmail.com |
| Dr Hari Shanker Joshi |
All India Institute of Medical Sciences |
Department of Community Medicine & Family Medicine
2nd Floor, Academic Block
All India Institute of Medical Sciences, Kunraghat, Gorakhpur, 273008
Gorakhpur
UTTAR PRADESH |
9415833751
drjoshiharish@gmail.com |
| Dr Chandramani Singh |
Dr Ram Manohar Lohia Institute of medical Sciences |
Dr Ram Manohar Lohia Institute of medical Sciences, Vibhuti Khand Gomati Nagar , Lucknow 226010
Lucknow
UTTAR PRADESH |
9931733280
cmaiims57@gmail.com |
| Dr Shailaja Mane |
Dr. D Y Patil Medical College, Hospital and Research Centre |
Dept. of Pediatrics, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra-411018
Pune
MAHARASHTRA |
9822595553
dr.shailajamane7@gmail.com |
| Dr Abhishek T Chavan |
Jeevan Rekha Hospital |
3rd floor, Room no. 2 Dept. of Pediatrics Dr. B.R. Ambedkar Road Opp Civil Hospital, Belagavi (Belgaum), Karnataka - 590002
India
Belgaum
KARNATAKA |
9113222185
dr.abhishektchavan@gmail.com |
| Dr Dinesh Kumar |
Uttar Pradesh University of Medical Sciences |
Department of Pediatrics, University of Medical Sciences Saifai, Etawah, Uttar Pradesh-206130
Etawah
UTTAR PRADESH |
7905113329
dineshkm.6688@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute of Medical Sciences Patna |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee All India Institute of Medical Sciences Gorakhpur |
Approved |
| Institutional Ethics Committee at Jeevan Rekha Hospital Belagavi |
Approved |
| Institutional Ethics Committee Dr. D. Y. Patil Vidyapeeth |
Approved |
| Institutional Ethics Committee Uttar Pradesh University of Medical Sciences |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention from chicken pox infection. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Varicella Vaccine |
Varicella vaccine (Live Attenuated, Freeze-dried, IP) of M/s Sinovac. A single dose (0.5mL) of test vaccine will be administered to the subject on Day 0 as a subcutaneous injection in the low border of the lateral deltoid of upper arm.
|
| Comparator Agent |
VARIPED® Vaccine |
Varicella Vaccine Live I.P By MSD Pharmaceuticals Pvt Ltd, India. A single dose (0.5mL) of comparator vaccine will be administered to the subject on Day 0 as a subcutaneous injection in the low border of the lateral deltoid of upper arm |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy pediatrics subjects of either sex aged 1 year to 12 years
2. Informed consent of the parents/LAR and their willingness to be followed up for at least 6 weeks after vaccination of their child
3. Parents/LAR with adequate literacy to fill the diary cards
Note Age of subject should be at least 12 completed months |
|
| ExclusionCriteria |
| Details |
1)Subjects with a history of anaphylaxis or serious reactions to other vaccines,
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.
#Close contact (family member or neighbor) with a diagnosed case of varicella infection.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Immunogenicity: Geometric mean titre of IgG antibodies to Varicella Zoster virus in the two groups at the end of the study
Safety, Tolerability: Alone & in comparison.
Number & severity of solicited local & systemic adverse events during the first 7 days post vaccination
Number, severity and relatedness of all unsolicited AEs through study period post vaccination
Number, severity and relatedness of serious adverse events (SAEs)
|
42 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Immunogenicity:
Sero-conversion rate at the end of the study for Varicella in the two groups
4- Fold Seroconversion rate for the subjects who are seropositive at baseline |
42 days |
|
|
Target Sample Size
|
Total Sample Size="344"
Sample Size from India="344"
Final Enrollment numbers achieved (Total)= "344"
Final Enrollment numbers achieved (India)="344" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/06/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Varicella (chickenpox) is an acute and highly contagious disease of childhood caused by human (alpha) herpesvirus 3 (Varicella-Zoster virus). It is of widespread distribution, occurs in epidemic waves and affects most people by 20 years of age. This will be a prospective, randomized, single blind, parallel, active controlled, multicenter, non-inferiority, phase III clinical trial in healthy pediatric subjects aged 1 to 12 years in India. The study will enroll approximately 344 healthy Indian subjects to receive single dose of either test Varicella vaccine (live attenuated) of Test or reference vaccine in 1:1 ratio. The study will be conducted in sequential manner wherein subject aged >6-12 years will be enrolled before subjects aged 1-6 years. The immune response will be evaluated at day 42 post vaccination and safety will be evaluated throughout the study. |