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Clinical Trials/CTRI/2021/10/037099
CTRI/2021/10/037099
Not yet recruiting
Phase 4

Evaluation of Immunogenicity, Efficacy and Safety of single dose of COVID-19 vaccines (Covishield, Covaxin and Sputnik V) in previously SARS-CoV2 infected individuals - A Randomized controlled clinical trial

Indian Council of Medical research ICMR0 sites0 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Indian Council of Medical research ICMR
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Indian Council of Medical research ICMR

Eligibility Criteria

Inclusion Criteria

  • •1\.Males and females \>\=18 years and willing to give informed consent
  • •2\.Group I and II: Subjects with positive history of RT\-PCR proven COVID\-19, 3 months or more, prior to their enrolment
  • •3\.Group III: Subjects with no history of COVID\-19 infection in the past
  • •4\.Females should be non\-pregnant and willing to adopt contraception for minimum three months (group 1 \- 3 months after the 1st dose; group 2 \& 3 \- during the period between 1st \& 2nd doses and 3 months after 2nd dose)
  • •4\.Subjects with co morbidities including Diabetes and Hypertension with stable medical condition

Exclusion Criteria

  • •1\.Subjects with significant co\-morbid conditions with unacceptable clinical and / or laboratory profile in view of the investigator
  • •2\.Those who are on long term steroid therapy (\>\=3 months) and immunosuppressive treatment including anticancer treatment within past 6 months
  • •3\.Those who are in immunosuppressed or immunodeficient state
  • •4\.Subjects with active malignancy of any organ or system
  • •5\.Those who have received blood / blood products / immunoglobulins in the past 3 months
  • •6\.Subjects on regular anticoagulant therapy
  • •7\.History of bleeding disorders
  • •8\.H/O hypersensitivity to any of the vaccines and / or the constituents in the vaccine

Outcomes

Primary Outcomes

Not specified

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