CTRI

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CTRI Number

CTRI/2023/12/060869 [Registered on: 28/12/2023] Trial Registered Prospectively

Last Modified On:

06/07/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Vaccine

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

To assess Immunogenicity And Safety Of Live Attenuated Varicella Vaccine Of Novo Medi Sciences Pvt. Ltd In Healthy Subjects

Scientific Title of Study

A Prospective, Randomized, Observer Blind, Parallel, Active Controlled, Multicentre, Non-Inferiority Phase III Study to Evaluate The Immunogenicity And Safety Of Live Attenuated Varicella Vaccine Of Novo Medi Sciences Pvt. Ltd Compared To a Marketed Varicella Vaccine In Healthy Subjects.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
CRNI/CTP/013 Version 1.0 dated 20 Mar 2023	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)

Name	Dr Chandramani Singh
Designation	Professor, Dept. of Community Medicine
Affiliation	All India Institute of Medical Sciences, Patna
Address	All India Institute of Medical Science, Dept. of Community Medicine Phulwari Sharif Patna, Bihar-801507 Patna BIHAR 801507 India
Phone
Fax
Email	cmaiims57@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Nidhi Singh
Designation	Head Clinical Research
Affiliation	Clinical Research Network India
Address	B-806-807, Advant Navis Business Park, Plot#7, Noida-Greater Noida Expressway, Sector 142, Gautam Buddha Nagar UTTAR PRADESH 201305 INDIA 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 Research
Affiliation	Clinical Research Network India
Address	B-806-807, Advant Navis Business Park, Plot#7, Noida-Greater Noida Expressway, Sector 142, Gautam Buddha Nagar UTTAR PRADESH 201305 INDIA UTTAR PRADESH 201305 India
Phone	9695237796
Fax
Email	nidhisingh@crnindia.org

Source of Monetary or Material Support

Novo Medi Sciences Pvt Ltd., Royal Status Building, Pandit Wamanrao Sadolikar Marg, Lokmanya Tilak Colony, Dadar, Mumbai, Maharashtra- 400014 Phone 022-4342 6100

Primary Sponsor

Name	Novo Medi Sciences Pvt Ltd.
Address	Royal Status Building, Pandit Wamanrao Sadolikar Marg, Lokmanya Tilak Colony, Dadar, Mumbai, Maharashtra- 400014 Phone 022-4342 6100
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
Clinical Research Network India Pvt Ltd	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

No of Sites = 7
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Chandramani Singh	All India Institute of Medical Sciences Patna	Dept. of Community Medicine, All India Institute of Medical Sciences, Patna Bihar- 801507 Patna BIHAR	9931733280 cmaiims57@gmail.com
Dr Pradeep N	Cheluvamba Hospital,Mysore Medical College and Research Institute,Mysore-570001	Department of Pediatrics, Cheluvamba Hospital,Mysore Medical College and Research Institute Mysore KARNATAKA	9611898080 drpradeepn80@yahoo.com
Dr Anil K Pandey	ESIC Medical College & Hospital	Clinical Trial Unit, Multidisciplinary Research Unit, ESIC Medical College & Hospital NH-3, NIT, Faridabad- 121001 Faridabad HARYANA	7042918222 drpandeyak@yahoo.co.in
Dr Abhishek T Chavan	Jeevan Rekha Hospital	Dr. B.R. Ambedkar Road Opp Civil Hospital Belagavi(Belgaum) Karnataka - 590002 India Belgaum KARNATAKA	9900291629 dr.abhishektchavan@gmail.com
Dr Raghu Raj Singh	New Leelamani Hospital Pvt Ltd	14-116, C-1,Parade Chauraha, Civil Lines, Kanpur, Uttar Pradesh-208001 Kanpur Nagar UTTAR PRADESH	9555989176 drraghurajsingh156@gmail.com
Dr Vijaykumar Bhagwan Barge	RCSM ,Medical College and Chhatrapati Pramila Raje General Hospital	Dept. Of Medicine, RCSM,Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416002, Kolhapur MAHARASHTRA	7969792775 drvijaybarge12@gmail.com
Dr Durgesh Kumar	Uttar Pradesh University of Medical Sciences	Department of Pediatrics Uttar Pradesh University of Medical Sciences, Saifai, Etawah Etawah UTTAR PRADESH	9026291170 dr.durgeshkm08@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 7
Name of Committee	Approval Status
Ethics Committee Jeevan Rekha Hospital	Approved
ESIC Ethics Committee	Approved
IEC,Rajarshee Chhatrapati Shahu Mahraj Govt. Medical College and Chhatrapati Pramila Raje General Hospital.	Approved
IEC-MMC and RI and Associated Hospital	Approved
Institute Ethics Committee All India Institute of Medical Sciences Patna	Approved
Institutional Ethics Committee Leelamani Hospital	Approved
Institutional Ethics Committee Uttar Pradesh University of Medical Sciences	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Varicella infections

Intervention / Comparator Agent

Type	Name	Details
Intervention	Varicella vaccine	For age groups 1-12 years: A single dose (0.5mL) of vaccine at day 0. For age groups 13-60 years: Two doses (0.5mL) of vaccine at day 0 and at day 42. Varicella Vaccine Live I.P (Freeze-dried) of Novo Medi Sciences Pvt Ltd; Manufactured by Changchun BCHT Biotechnology Co. China.
Comparator Agent	VARIPEDÂ® Vaccine	For age groups 1-12 years: A single dose (0.5mL) at day 0. For age groups 13-60 years: Two doses (0.5mL) at day 0 and day 42. Varicella Vaccine Live I.P By MSD Pharmaceuticals Pvt Ltd, India

Inclusion Criteria

Age From	1.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1. Healthy subjects of either sex aged 1 year to 60 years. 2. Informed consent/assent of the subject/parents/LAR and their willingness to be followed up for entire study period. 3. Subject/Parents/LAR with adequate literacy to fill the subject diary cards. 4. Female participants of reproductive potential must: Have a negative urine pregnancy test prior to each study vaccination (on the day the participant is vaccinated and before vaccine is administered). Agree to remain abstinent, or use (or have their partner use) 2 acceptable methods of birth control. Abstinence or 2 acceptable methods of birth control must be practiced or used from the day of enrolment, throughout the duration of the study, and continued until 3 months following the last study vaccination. 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 hematopoietic
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 neighbour) with a diagnosed case of vericella infection

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Investigator Blinded

Primary Outcome

Outcome	TimePoints
1.Sero-conversion rate at 6 weeks post vaccination for children & at 6 weeks post dose 2 for adolescents/adults in test & reference arm. 2.Geometric mean titre of IgG antibodies to Varicella Zoster virus at 6 weeks postvaccination for children and at 6 weeks post dose 2 for adolescents/adults in test and reference arm.	6 weeks

Secondary Outcome

Outcome	TimePoints
1.4- Fold Seroconversion (antibody rise) rate at 6 weeks post vaccination for children & at 6 weeks post dose 2 for adolescents/adults in test and reference arm. 2.Geometric mean fold rise (GMFR) from day 0 (pre-vaccination) to 6 weeks post vaccination for children and to 6 weeks post dose 2 for adolescents/adults.	6 weeks

Target Sample Size

Total Sample Size="424"
Sample Size from India="424"
Final Enrollment numbers achieved (Total)= "424"
Final Enrollment numbers achieved (India)="424"

Phase of Trial

Phase 3

Date of First Enrollment (India)

16/01/2024

Date of Study Completion (India)

09/04/2024

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="5"
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

Varicella (chickenpox) is an acute and highly contagious disease of childhood caused by human (alpha) herpesvirus 3 (Varicella-Zoster virus) This will be a prospective, randomized, observer blind, parallel, active controlled, multicenter, non-inferiority, phase III clinical trial in healthy subjects aged 1 to 60 years in India. The study will enroll approximately 424 healthy Indian subjects to receive single dose or two doses of either test Varicella vaccine (live attenuated) of Novo Medi Sciences Pvt. Ltd or VARIPEDÂ® Vaccine (Varicella Vaccine Live I.P By MSD Pharmaceuticals Pvt Ltd, India) in 1:1 ratio. The study will be conducted in sequential manner, wherein subject aged 18 - 60 years will be enrolled first followed by subjects aged 13 -17 years, 7-12 years & 1-6 years in sequentially manner.