| CTRI Number |
CTRI/2017/09/009760 [Registered on: 14/09/2017] Trial Registered Prospectively |
| Last Modified On: |
26/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of immunogenicity, safety and tolerability of Single Dose of Hepatitis A (Live) Vaccine obtained by Freeze-dried process from Sinopharm against BiovacTM-A (Freeze-dried Live Attenuated Vaccine from Wockhardt)in Healthy Indian Children. |
|
Scientific Title of Study
|
A Prospective, Multicentre, Randomized, Double Blind, Parallel Group, Phase III Study Comparing Immunogenicity, Safety, and Tolerability of Single Dose of Hepatitis A (Live) Vaccine, Freeze-dried from Sinopharm versus BiovacTM-A (Freeze-dried Live Attenuated Hepatitis A Vaccine) from Wockhardt in Healthy Indian Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SIPL-01,version 2.0 dated 23 may 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Puneet Misra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Centre for Community Medicine, All India Institute of Medical Sciences, Ansari Nagar
South
DELHI
110029
India |
| Phone |
919868397372 |
| Fax |
|
| Email |
doctormisra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonika Newar |
| Designation |
Medical Monitor |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
JSS Medical Research India Private Limited
6th Floor, Vatika Mindscapes (Tower B)
Plot 12/2, Sector 27 D
Faridabad
HARYANA
121003
India |
| Phone |
91800799887 |
| Fax |
9101296613520 |
| Email |
sonika.newar@jssresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shariq Anwar |
| Designation |
Head-Operations |
| Affiliation |
JSS Medical Research India Private Limited |
| Address |
6th Floor, Vatika Mindscapes (Tower B)
Plot 12/2, Sector 27 D
Faridabad
HARYANA
121003
India |
| Phone |
919810979215 |
| Fax |
9101296613520 |
| Email |
shariq.anwar@jssresearch.com |
|
|
Source of Monetary or Material Support
|
| Sinopharm India Private Limited Unit 403 -404 A, Southern Park Building, Saket District Centre, Saket, New Delhi -110017, India |
|
|
Primary Sponsor
|
| Name |
Sinopharm India Private Limited |
| Address |
Unit 403 -404 A, Southern Park Building, Saket District Centre, Saket, New Delhi -110017, India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JSS Medical Research India Private Limited |
6th Floor, Vatika Mindscapes (Tower B)
Plot 12/2, Sector 27 D
Faridabad, Haryana-121003, India
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Puneet Misra |
All India Institute of Medical Sciences |
Room no. 35, Centre for Community Medicine
Ansari Nagar-110029, India
South
DELHI |
91-9868397372
doctormisra@gmail.com |
| Dr Apurba Ghosh |
Institute of Child Health |
Room no. 113, Project room, Ground floor, no. 11, Dr. Biresh Guha Street-700017, India
Kolkata
WEST BENGAL |
91-9830052887
apurbaghosh@yahoo.com |
| Dr Sheila Bhave |
KEM Hospital |
Room no. 315, third floor, Department of Pediatrics,
Sardar Moodliar Road, Rasta Peth– 411011, India
Pune
MAHARASHTRA |
91-9823091871
sheilabhave@yahoo.co.in |
| Dr Madhu Gupta |
Postgraduate Institute of Medical Education & Research |
Room no. 125, Department of Community Medicine,
School of Public Health,
Chandigarh-160012
Chandigarh
CHANDIGARH |
91-7087008223
madhugupta21@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
| Institute Ethics Committee, PGIMER, Chandigarh |
Approved |
| Institutional Ethics Committee, ICH, Kolkata |
Approved |
| KEM Hospital Research Centre Ethics Committee, KEM Hospital, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hepatitis A |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biovac-A |
(Freeze-dried Live Attenuated Hepatitis A Vaccine) from Wockhardt. |
| Intervention |
Hepatitis A (Live) Vaccine |
Single Dose of Hepatitis A (Live) Vaccine, Freeze-dried from Sinopharm |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy children of either sex between the age range of 1-12 years
2. Subjects with negative anti-HAV antibodies (< 20mIU/ml)
3. Subjects’ parents/guardians willing to participate and who provide written informed consent (thumb impression for those who are not literate) for children
|
|
| ExclusionCriteria |
| Details |
1. Subject with history of hypersensitivity to the vaccine or any of the ingredients of the vaccine, including subsidiary materials and kanamycin sulfate
2. Subject with previous history of Hepatitis A infection and subsequent jaundice manifested due to the infection
3. Subjects who have earlier received even a single dose of Hepatitis A vaccine
4. Subjects who were administered any live attenuated vaccine within 30 days.
5. Subjects who were administered subunit or inactivated vaccines within 14 days
6. Subjects suffering from acute or chronic infections or any other serious liver, renal, cardiac, respiratory or metabolic disease
7. Subjects suffering from acute febrile illnesses
8. Subjects with a present or past history of allergic reactions.
9. Subjects with clinically significant abnormal hematological and/or biochemical investigations.
10. Subjects who have participated in an investigational study within the past 2 weeks
11. Subjects currently receiving immunosuppressant drugs
12. Subjects with uncontrolled epilepsy or other progressive diseases of nervous system
13. Subjects with any other illnesses which may impact the immune response or seroconversion as per investigator’s discretion
14. Subjects unwilling to comply with the study procedures
15. Subjects with immunodeficiency, HIV, and/or who are immunocompromised
16. Subjects with a history of administration of a single dose of Hepatitis A vaccine and/or any immunoglobulin at least 3 months prior to enrollment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of children with seroprotection (defined as an anti-HAV antibody (Ab) level ≥ 20 mIU/mL) |
At 8 week from the day of immunization.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Adverse events (AEs) and serious AEs (SAEs)
• Change in laboratory parameters (hematology and biochemistry) from baseline to 8 weeks
• Change in brief clinical examination from baseline to 8 weeks
• Vital signs
• Immediate and delayed reaction post vaccination
|
At 8 week from the day of immunization. |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/09/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, multicentre, randomized, double blind, parallel group, phase III study in which immunogenicity, safety, and tolerability of single dose of Hepatitis a (live) vaccine, freeze-dried from sinopharm versus is compared with BiovacTM a (freeze-dried live attenuated hepatitis a vaccine) from Wockhardt. The study involves approximately 176 healthy Indian children, who had not received hepatitis a vaccine and had anti-HAV ab levels of < 20 mIU/ml prior to enrolment into the study, after 8 weeks of immunization. The study has to be conducted approximately at 5 sites in India with a primary objective of comparing the immune response of healthy Indian children treated with test drug/ vaccine versus reference drug/vaccine. The secondary objective of the study is to compare the safety and tolerability profile of test and reference drug/vaccine. The study consists of 3 visits: · Visit 1 (Day -5)(Screening Visit) · Visit 2 (Day 0 + 2 days) (Baseline Visit) · Visit 3 (Week 8 +7 days) (End of Study [EOS] Visit) At week 8, proportion of children with seroprotection (defined as an anti-HAV antibody (Ab) level ≥ 20 mIU/mL) will be assessed which is the primary endpoint of the study. Adverse events (AEs) and serious AEs (SAEs), Change in laboratory parameters (hematology and biochemistry) from baseline to 8 weeks, Change in brief clinical examination from baseline to 8 weeks, Vital signs, Immediate and delayed reaction post vaccination are to be assessed as secondary endpoints. |