CTRI Number |
CTRI/2021/01/030782 [Registered on: 27/01/2021] Trial Registered Prospectively |
Last Modified On: |
27/01/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study |
Cohort Study |
Study Design |
Other |
Public Title of Study |
COVID-19 Vaccine effectiveness and hesitancy study in Healthcare Workers of Max Group of Hospitals |
Scientific Title of Study |
“A prospective, longitudinal, observational, postlicensure vaccine evaluation study to assess the effectiveness of COVID-19 vaccine among the Healthcare workers of Max group of hospitals” |
Trial Acronym |
|
Secondary IDs if Any |
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study) |
Name |
Sujeet Jha |
Designation |
Principal Director |
Affiliation |
Max Healthcare |
Address |
Institute of Endocrinology, Diabetes, and Metabolism, Max Super Speciality Hospital, 2, Press Enclave Road, Saket
South DELHI 110017 India |
Phone |
9910609000 |
Fax |
|
Email |
sujeet.jha@maxhealthcare.com |
|
Details of Contact Person Scientific Query |
Name |
Sujeet Jha |
Designation |
Principal Director |
Affiliation |
Max Healthcare |
Address |
Institute of Endocrinology, Diabetes, and Metabolism, Max Super Speciality Hospital, 2, Press Enclave Road, Saket
DELHI 110017 India |
Phone |
9910609000 |
Fax |
|
Email |
sujeet.jha@maxhealthcare.com |
|
Details of Contact Person Public Query |
Name |
Sujeet Jha |
Designation |
Principal Director |
Affiliation |
Max Healthcare |
Address |
Institute of Endocrinology, Diabetes, and Metabolism, Max Super Speciality Hospital, 2, Press Enclave Road, Saket
DELHI 110017 India |
Phone |
9910609000 |
Fax |
|
Email |
sujeet.jha@maxhealthcare.com |
|
Source of Monetary or Material Support |
Max Healthcare and CSIR-IGIB |
|
Primary Sponsor |
Name |
CSIRInstitute of Genomics and Integrative Biology |
Address |
DTC Bus Depot, South Campus, Mathura Road, near to Sukhdev Vihar, New Delhi, Delhi 110025 |
Type of Sponsor |
Other [Council of Scientific and Industrial Research (CSIR)] |
|
Details of Secondary Sponsor |
Name |
Address |
Max Healthcare A Unit of Devki Devi Foundation |
2, Press Enclave Road, Saket, New Delhi-110017 |
|
Countries of Recruitment |
India |
Sites of Study |
No of Sites = 1 |
Name of Principal Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Sujeet Jha |
Max Super Speciality Hospitals |
Saket, Vaishali, Patparganj, Gurgaon, Shalimar Bagh, Lajpat Nagar New Delhi DELHI |
9910609000
sujeet.jha@maxhealthcare.com |
|
Details of Ethics Committee |
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Devki Devi Foundation |
Approved |
|
Regulatory Clearance Status from DCGI |
|
Health Condition / Problems Studied |
Health Type |
Condition |
Healthy Human Volunteers |
Undergoing COVID-19 vaccination |
|
Intervention / Comparator Agent |
Type |
Name |
Details |
Intervention |
Not applicable |
Not applicable |
|
Inclusion Criteria |
Age From |
18.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
• HCWs of Max group of hospitals, irrespective of age and gender • HCWs who are being offered Govt. of India approved COVID-19 vaccines Covishield or COVAXIN |
|
ExclusionCriteria |
Details |
Refusal to give informed consent, or contraindication to venipuncture. |
|
Method of Generating Random Sequence |
Not Applicable |
Method of Concealment |
Not Applicable |
Blinding/Masking |
Not Applicable |
Primary Outcome |
Outcome |
TimePoints |
Seropositivity in participants after vaccination |
7, 14, 28, 45, 90 days after vaccination, may be extended further |
|
Secondary Outcome |
Outcome |
TimePoints |
Effectiveness of COVID-19 vaccines |
30 days, 90 days, may be extended further |
|
Target Sample Size |
Total Sample Size=“1000” Sample Size from India=“1000” 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 |
N/A |
Date of First Enrollment (India) |
05/02/2021 |
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=“6” Days=“0” |
Recruitment Status of Trial (Global) |
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details |
Yes, we will publish the results |
Individual Participant Data (IPD) Sharing Statement |
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response – NO
|
Brief Summary |
We have designed this study to evaluate COVID-19 vaccine effectiveness by antibody testing and evaluate vaccine hesitancy rate, among the healthcare workers of Max Group of Hospitals.
We would do antibody testing at day 0 (vaccination day or pre-vaccination) followed by 7, 14, 28, 45, 90th day of vaccination. This study would involve a brief questionnaire asking about the health status of the participants related to COVID-19 and side-effects post-vaccination. |