PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 13:13:18 GMT)

CTRI Number CTRI/2021/01/030582 [Registered on: 19/01/2021] - Trial Registered Prospectively Last Modified On 19/01/2021 Post Graduate Thesis No Type of Trial Observational Type of Study Cohort Study Study Design Other Public Title of Study A Real World Evaluation of safety, immunogenicity and efficacy of COVID-19 Vaccines among workers Scientific Title of A real world study to evaluate the safety, immunogenicity and efficacy of COVID 19 vaccines during Study the national vaccination roll out among health care workers in a tertiary care Secondary IDs if Any Secondary ID Identifier MIER/COVID-001/2021 Version No 1.0 Dated Protocol Number 06-01-2021 Details of Principal Details of Principal Investigator Investigator or overall Name Dr Sushila Kataria Trial Coordinator (multi-center study) Designation Senior Director Department of Internal Affiliation Medanta The Medicity Address Medanta The Medicity Department of Internal Medicine Division Internal Medicine Room No 30 Ch Baktawar Singh Road Sector 38 Gurgaon 122001 India Phone 0124-4141414 Fax 0124-4834498 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Vikas Deswal Query) Designation Consultant Department of Internal Medicine Affiliation Medanta The Medicity Address Medanta The Medicity Department of Internal Medicine Division Internal Medicine Room No 24 Ch Baktawar Singh Road Sector 38 Gurgaon HARYANA 122001 India Phone 0124-4141414 Fax 0124-4834498 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Pooja Sharma Designation Associate Director and Head Affiliation Medanta Institute of Education and Research Address Medanta The Medicity Department Clinical Research Medanta Institute of Education and Research Division Clinical Research Sector 38 Gurgaon Haryana Gurgaon HARYANA 122001

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India Phone 9877535739 Fax 0124-4834498 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Medanta Institute of Education and Research Medanta The Medicity Sector 38 Gurgaon Haryana Primary Sponsor Primary Sponsor Details Name Medanta Institute of Education and Research Address Medanta The Medicity Sector 38 Gurgaon Haryana Type of Sponsor Research institution Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Sushila Kataria Medanta The Medicity Department of Internal 9818828078 Medicine Division 0124-4834498 Internal Medicine Room dr.sushilakataria@gmail No 30 Ch Baktawar .com Singh Road Sector 38 Gurgaon HARYANA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Medanta Institutional Approved 11/01/2021 No Ethics Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers NA Intervention / Type Name Details Comparator Agent Intervention Nil Nil Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 99.00 Year(s) Gender Both Details All adults above 18 years of age who are working at Medanta The Medicity Gurgaon and are listed in the first COVID 19 vaccination list shared by Medanta HR Team with the GOI Officials will be considered for participation
Exclusion Criteria Exclusion Criteria Details Participation in COVID-19 prophylactic drug trials before or during the duration study

Receipt of any vaccine (licensed or investigational) other than the study intervention within 14 days before and after each study vaccination

History of allergic disease or reactions likely to be exacerbated by

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any component of COVISHIELD

Active ongoing laboratory confirmed COVID 19

Administration of immunoglobulins and/or convalescent plasma within the three months preceding the planned administration of the vaccine Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints To assess the safety of the vaccines by actively 06 months reported AE/SAE in the first week of vaccination after each dose of the vaccine (Adverse Event Following Immunization)

To assess the safety of the vaccines by passively reported Adverse Vaccine reactions, Vaccine associated Adverse Events of Special Interest (AESI) ,such as Vaccine Associated Enhanced Respiratory Disease (ERD) Secondary Outcome Outcome Timepoints To assess humoral immunogenicity (Time 06 months Frame: 180 days) Target Sample Size Total Sample Size=5000 Sample Size from India=5000 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 23/01/2021 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details None Brief Summary To understand the safety of COVID 19 vaccine in real world experience as national roll out in health care workers. Secondary aim of the study will be to generate data on immunogenicity. Total timeframe of the study will be 118 days (window period of 7 days). Efficacy of the COVID19 vaccination will be assessed in severe and non-severe COVID-19.

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