COVID-19 Vaccine effectiveness and hesitancy study in Healthcare Workers of Max Group of Hospitals

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  
Status 
Not Applicable 
 
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.

NOTE

What is the Clinical Trials Registry – India?

The Clinical Trials Registry – India (CTRI) launched on 20th July 2007 is managed by the ICMR-National Institute of Medical Statistics, New Delhi, India. The CTRI ( www.ctri.nic.in) is an online, free and searchable system for the prospective registration of all clinical studies being conducted in India. In addition, the CTRI also registers clinical studies being conducted in countries which do not have a Primary Registry of their own.

Registration of all regulatory clinical trials is mandatory as per the drug licensing authority in India i.e. the Drugs Controller General (India) (DCGI). In addition, several journal editors, ethics committees and medical colleges have made it mandatory to register clinical studies in the CTRI.

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