A phase III, randomized, multi-centre, double blind, placebocontrolled, study to evaluate efficacy, safety and immunogenicityof Novel Corona Virus -2019-nCov vaccine candidate of M/sCadila Healthcare Limited. - ZyCoV-D

Cadila Healthcare Ltd0 sites28,216 target enrollmentStarted: TBDLast updated: November 13, 2023

Trial Snapshot

No summary available.

•1.Healthy subject of either gender =12 years of age.
•2. Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study.
•3. Ability to provide informed consent from the adult subjects or from the parents of paediatric
•subjects. Additionally, assent from paediatric subjects (Audio video recording in case of
•vulnerable subject).
•4. Adult subjects or parents of paediatric subjects literate enough to fill the diary card.
•5. Subjects with good health or with stable medical condition for chronic disease. (Stable
•condition is defined as there is no change in the medication or dose of medication or severity
•of disease from last 3 months before enrolment.)
•6. 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 will agree to
•use contraception.
•7. Willing to allow storage and future use of biological samples for future research.

•1.Febrile illness (temperature = 38°C or 100.4°F) or any acute illness or infection within 4
•weeks of enrolment.
•2. Laboratory confirmed SARS-CoV-2 positive.
•3. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days.
•4. History of SARS/ MERS infection.
•5. Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine.
•6. Past history of hypersensitivity reaction or any serious adverse event after any vaccination.
•7. Past history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation
•8. Subjects with confirmed immunosuppressive or immunodeficiency disorder; or subjects on
•any immunosuppressive or immunostimulant therapy.
•9. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic,
•gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological
•10. Subjects administered blood, blood containing products or immunoglobulins within the last
•3 months or planned administration during the study.
•11. Any other vaccine administration within the last 30 days or planned to be administered
•during the study period.
•12. Pregnant and lactating women.
•13. Participation in another clinical trial in the past 3 months.
•14. History of drug / alcohol abuse.

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