CTRI/2021/03/032051
Completed
Phase 1
A prospective, randomized, phase I/II clinical study to evaluate the safety and immunogenicity of 3mg dose of Novel Corona Virus -2019-nCov vaccine candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cadila Healthcare Limited
- Enrollment
- 150
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Healthy subject of either gender 18 to 60 years of age
- •2\.Informed consent from the subjects (Audio video recording in case of vulnerable subject)
- •3\.Adult subjects literate enough to fill the diary card
- •4\.Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization), from screening until completion of the follow\-up visit and males who agree to use contraception
Exclusion Criteria
- •1\.Febrile illness (temperature \>\= 38°C or 100\.4°F) or any acute illness or infection within 4 weeks of enrolment
- •2\.History or laboratory evidence of confirmed SARS\-CoV\-2 positive
- •3\.History of contact with a confirmed active SARS\-CoV\-2 positive patient within 14 days
- •4\.Subjects positive for antibodies against SARS\-CoV\-2 on antibody detection test / RTPCR positive at the time of screening
- •5\.History of SARS/ MERS infection
- •6\.Previous participation in any clinical trial of a SARS\-CoV\-2 candidate vaccine
- •7\.Past history of hypersensitivity reaction or any serious adverse event after any vaccination
- •8\.Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •9\.Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •10\.Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder
Outcomes
Primary Outcomes
Not specified
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