| CTRI Number |
CTRI/2025/07/090136 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Safety and immunogenicity study of varicella-zoster virus (VZV) vaccine in healthy subjects. |
|
Scientific Title of Study
|
A randomized, open label clinical trial to evaluate the safety and immunogenicity of varicella-zoster virus (VZV) vaccine in healthy subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRSC23001, Version 02 dated 16.06.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arani Chatterjee |
| Designation |
Head (President) CRO |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
CRO department
1389, Trasad Road
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India |
| Phone |
9925002564 |
| Fax |
|
| Email |
arani.chatterjee@cadilapharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Amarsheda |
| Designation |
Assistant General Manager - CRO |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
Clinical Trial Department
1389, Trasad Road
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India |
| Phone |
9925002565 |
| Fax |
|
| Email |
ashish.a@cadilapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Patel |
| Designation |
General Manager (Head) Clinical Trial |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
Clinical Trial Department
1389, Trasad Road
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India |
| Phone |
9925002566 |
| Fax |
|
| Email |
sanjay.p@cadilapharma.com |
|
|
Source of Monetary or Material Support
|
| Cadila Pharmaceutical Limited 1389, Trasad Road, Dholka, Ahmedabad-382225. India. |
|
|
Primary Sponsor
|
| Name |
Cadila Pharmaceutical Limited |
| Address |
1389, Trasad Road, Dholka,
Ahmedabad. 382225,
Gujarat, India. |
| 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 Maharshi Desai |
Apollo Hospital International Ltd. |
Department of Critical Care
Plot No.1A, Bhat GIDC estate, Dist. Gandhinagar-382428
Gandhinagar
GUJARAT |
9825044828
maharshi_desai@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Clinical study_Apollo hospitals International ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adult Human Subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Not applicable |
| Intervention |
Varicella-zoster virus (VZV) vaccine by Cadila
Pharmaceuticals Limited, India |
Dose: Two Intramuscular (IM) injection of 50 microgram, 75 microgram and 100 microgram.
Each dose to be give in 3 schedules (i.e. 1. Day 0 & Day 42; 2. Day 0 and Day 56; 3. Day 0 and Day 84). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adult subjects of either gender with 18 years or more of age.
Subject’s BMI within normal limit of 18.50-30.00 kg/m2 (inclusive both).
Subjects in good health at the time of randomization into the study.
Subjects able to understand and provide the written informed consent.
Subject willing to follow all study requirements.
Subjects with documented negative test for human HIV-1/2, HBsAg and HCV.
Female subjects of childbearing potential. |
|
| ExclusionCriteria |
| Details |
Subject with history of chicken pox /herpes zoster disease.
Subjects with history of vaccination with any chicken pox vaccine, varicella or zoster vaccine.
Subjects with history of allergy or hypersensitivity reaction to any vaccine component.
Subject is having a history of disease or any underlying medical conditions.
Subject having drug intake in the past 2 weeks of proposed vaccination date.
Subjects using any immunosuppressive therapy, use of nontopical antiviral therapy with activity against herpes virus.
Subject is having a history of adverse reactions during previous vaccinations.
Any clinically significant abnormal laboratory findings during screening.
Any other vaccine administration within the last 30 days or planned to be administered during the study period.
Pregnant and lactating girls and female subjects of child bearing age not using acceptable contraceptive measures.
Subjects who have received blood transfusion or participated in another clinical trial during past 3 month. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and reactogenicity based on Frequency of and percentage AE and SAE for recommendation of dose and dosing regimen for Phase-II clinical trial. |
Within 7 days post- each vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the immunogenicity results of the test vaccine, based on IgG antibody
response. |
On second vaccination and Day 42 after second vaccination |
| To evaluate the safety profile of test vaccine |
After day 7 of each vaccination |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/12/2025 |
| Date of Study Completion (India) |
19/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This Phase-I, prospective, randomized, FIH, open-label, parallel, dose escalation clinical trial will the objective to assess the safety and immunogenicity of the VZV Vaccine in healthy adult human subjects. |