| 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. |
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