CTRI/2022/07/044215 [Registered on: 21/07/2022] Trial Registered Prospectively
Last Modified On:
20/02/2024
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 clinical trial to see the immune response and safety of Varicella vaccine of VHB Life Sciences Limited Ltd with other marketed Varicella vaccine in children aged between 1 to 12 years.
Scientific Title of Study
A Phase-III, Randomized, Open Label, Parallel Group, Active Controlled, Multicentre, Non-Inferiority Clinical Study to Evaluate the Immunogenicity and Safety Of Varivax® [Varicella vaccine (Live Attenuated, Lyophilized I.P) of VHB Life Sciences Limited] Compared to a Marketed Varicella Vaccine in Healthy Paediatric Subjects aged between 1 to 12 years.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
BCR-VHB-001 Version No. 2.0 dated 28 Feb 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ramchandra Keshav Dhongade
Designation
Principal Investigator
Affiliation
Sant Dnyaneshwar Medical Education and Research Centre
Address
Department of Paediatrics, ground floor, 69FA Sadashiv peth, Laxmi Road, Opp. Vijay Talkies, Pune-411030, Maharashtra
Pune MAHARASHTRA 411030 India
Phone
9011095436
Fax
Email
researchadmin@shaishavclinic.com
Details of Contact Person Scientific Query
Name
Dr Neeta Nargundkar
Designation
Managing Director
Affiliation
Biosphere Clinical Research Pvt Ltd
Address
Office No. 02, 03 & 04, 2nd Floor Highland Corporate Center,
Kapurbawdi Junction, Thane west Thane MAHARASHTRA
Thane
MAHARASHTRA
Thane MAHARASHTRA 400607 India
Phone
02241006794
Fax
02241006794
Email
drneeta@biospherecro.com
Details of Contact Person Public Query
Name
Dr Neeta Nargundkar
Designation
Managing Director
Affiliation
Biosphere Clinical Research Pvt Ltd
Address
Office No. 02, 03 & 04, 2nd Floor Highland Corporate Center,
Kapurbawdi Junction, Thane west Thane MAHARASHTRA
Thane
MAHARASHTRA
Thane MAHARASHTRA 400607 India
Phone
02241006794
Fax
02241006794
Email
drneeta@biospherecro.com
Source of Monetary or Material Support
VHB Life Sciences Limited
50AB, Government Industrial Estate,
Charkop, Kandivali West,
Mumbai 400 067, Maharashtra, India
Primary Sponsor
Name
VHB Life Sciences Limited
Address
50 AB, Government Industrial Estate,Charkop, Kandivali West,Mumbai 400 067, Maharashtra, India
Department of Pediatrics, Room No. llll,First floor, Medical Collage Complex, Gate no.05,All India
Institute of Medical Sciences, G. E Road Tatibandh Raipur- 492099 Raipur CHHATTISGARH
8224014667
dratuljindal@gmail.com
Dr Saumyen De
College of Medicine and Sagore Dutta Hospital
Department of Paediatrics,578, B.T Road, Kamarhati, Kolkatta- 700058, West Bengal, India Kolkata WEST BENGAL
9051803377
saumyen76@gmail.com
DrJyotsna Seepana
Government Medical College and Government General Hospital (Old RIMSGGH)
Department of Paediatrics,1st Floor, Balaga Srikakulam-- 532001, Andhra Pradesh, India
Srikakulam ANDHRA PRADESH
8942279033
drjyotsnaggh@yahoo.com
Shalaka Patil
Grant medical college & Sir J J Group of Hospitals
Department of Paediatrics,
Cama and Albless Hospital , Near BMC Office, Mahapalika Marg, Opposite Azad Maidan, Mumbai-400001 Mumbai MAHARASHTRA
07738085484
healthforall2020@gmail.com
Dr Hriday De
Institute of Child Health Hospital
Ground Floor, Project Room,11, Dr. Biresh Guha Street, Kolkata-700017, West Bengal, India Kolkata WEST BENGAL
9735846215
hridayde2010@gmail.com
Dr Pradeep N
Mysore Medical College and Research Institute and Associated Hospitals,
Department of Paediatrics,ground floor, Cheluvamba Hospital,Irwin Road, Mysore, Karnataka-570001, India Mysore KARNATAKA
09611898080
drpradeepn80@yahoo.com
Dr V K Goyal
Panchsheel Hospital Pvt. Ltd
Ground floor, C3 63A 64A Opp. Gokal Puri Police Station, Yamuna Vihar ,New Delhi - 110053 India. New Delhi DELHI
9810106800
vkgoyal22@gmail.com
Dr Deepali Ambike
PCMC’s PGI Yashwantrao Chavan Memorial Hospital
Department of Paediatrics,Second floor,
Sant Tukaram Nagar, Pimpri, Pune-411018, Maharashtra, India Pune MAHARASHTRA
9373002072
ambikedeepa@gmail.com
Dr Ramchandra Keshav Dhongade
Sant Dnyaneshwar Medical Education and Research Centre
Department of Paediatrics,
ground floor, 69FA
Sadashiv peth, Laxmi
Road, Opp. Vijay
Talkies, Pune-411030,
Maharashtra Pune MAHARASHTRA
9011095436
researchadmin@shaishavclinic.com
Dr Sanket Goyal
W Pratiksha Hospital,
Department of Paediatrics, Golf Course Ext Rd, Sushant Lok- 2, Sector- 56, Gurugram- 122011, Haryana, India Gurgaon HARYANA
Institutional ethics Committee, College of Medicine and Sagore Dutta Hospital
Submittted/Under Review
Institutional Ethics Committee, Mysore Medical College and Research Institute and Associated Hospitals
Approved
Institutional Ethics Committee, PCMC’s PGI Yashwantrao Chavan Memorial Hospital
Approved
North East Healthcare Private Limited Ethics committee
Submittted/Under Review
Sant Dnyaneshwar Medical Education and Research Centre, Institutional Review Board
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Active immunization for the prevention of disease caused by Varicella virus
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Varicella vaccine (Live
Attenuated, Freeze-dried, IP) Marketed in India
Inject s.c. 0.5 ml of the vaccine at the deltoid insertion area of the lateral upper arm as a single dose
Intervention
Varivax® [Varicella vaccine (Live Attenuated, Lyophilized I.P) of VHB Life Sciences Limited]
Inject s.c. 0.5 ml of the vaccine at the deltoid insertion area of the lateral upper arm as a single dose
Inclusion Criteria
Age From
1.00 Year(s)
Age To
12.00 Year(s)
Gender
Both
Details
1. Male and female, paediatric subjects between 1 to 12 years of age at the time of vaccination. Cohort 1: Subjects between from 1 to < 6 years old.
Cohort 2: Subjects between from 6 to12 years old. 2. Healthy subjects as determined by investigator’s clinical examination and assessment of child’s medical history.
3. The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, can, and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, respects intervals between visits).
4. Subjects with axillary temperatures ≤ (37°C/98.6°F).
5. Written informed consent /assent obtained from the subject and parent(s)/LAR(s) of the subject
ExclusionCriteria
Details
1. Subjects with a history of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex or gelatin.
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 an acute febrile illness at the time of randomization.
4. Any other vaccine administration within 30 days of initiation of the study or planned during the study period.
5. Subjects with a history of convulsions, seizures, other central nervous system diseases.
6. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
7. Any confirmed or suspected immunosuppressive or immune deficient condition, based on medical history and physical examination (no laboratory testing required).
8. Subjects with any other clinically significant concurrent illness affecting immune response after vaccination.
9. Blood dyscrasia as, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
10. Chronic administration (defined as 14 or more consecutive days) of immune suppressants, or other immune-modifying drugs within 6 months prior to the first vaccine dose or any planned administration of immune suppressive and immune-modifying drugs during the entire study.
- For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent.
- Inhaled and topical steroids are allowed.
11. Subjects who have received blood, blood products or immunoglobulins during the preceding 6 months or have planned during the study period.
12. Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
13. Any other condition which, in the opinion of the Investigator, prevents the child from participating in the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
The percentage of subjects who achieved positive seroconversion at the end of the study.
29 Days
Secondary Outcome
Outcome
TimePoints
Geometric mean titre of IgG antibodies to Varicella Zoster virus at the end of the study.
29 Days
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study is a Randomized, open label, parallel group, active controlled, multicentre, non-inferiority clinical study to evaluate the immunogenicity and safety of Varivax® [Varicella vaccine (Live Attenuated, Lyophilized I.P) of VHB Life Sciences Limited] compared to a marketed Varicella Vaccine in healthy paediatric subjects aged between 1 to 12 years.
- The primary outcome evaluates percentage of subjects who achieved positive seroconversion at the end of the study Day 29(+7) after vaccination.
- The secondary outcome evaluates Geometric mean titre of IgG antibodies to Varicella Zoster virus at the end of the study Day 29(+7) after vaccination.
- Safety will be assessed based on the frequency of Adverse Events from the time of injection till the end of study.