None listed
Conditions
Interventions
Intervention1: Novel Corona Virus-2019-nCov Vaccine: (1)Dose:-0.2 ml (0.1ml in eacharms) with Pharmacjet
(2)Site of administration:- Upper Arm
(3)Frequency:-single time at day 0 day 28 and day 56.
(4
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 therapy. 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 disorder. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the efficacy of ZyCoV-D in the prevention of virologically confirmed symptomatic COVID-19 cases as compared to placebo.Timepoint: Day 84 to Day 364 | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed mild COVID-19 cases as compared to placebo.Timepoint: Day 84, Day 186, Day 252, Day 364 ;To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed asymptomatic COVID-19 cases as compared to placebo.Timepoint: Day 84, Day 186, Day 252, Day 364;To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed COVID-19 death as compared to placebo.Timepoint: Day 84, Day 186, Day 252, Day 364;To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed moderate COVID-19 cases as compared to placebo.Timepoint: Day 84, Day 186, Day 252, Day 364;To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed severe COVID-19 cases as compared to placeboTimepoint: Day 84, Day 186, Day 252, Day 364;To evaluate persistence of immunogenicity after first dose of ZyCoV-D.Timepoint: Day 56, Day 84, Day 168, Day 252 and Day 364;To evaluate safety and tolerability of ZyCoV-D.Timepoint: Day 0 to Day 364;To evaluate the immunogenicity by neutralizing antibody (nAb) assay in subset of population.Timepoint: Day 0, Day 56, Day 84, Day 186, Day 252, Day 364;To evaluate the Lot-to-Lot consistency based on the IgG titer of the three consecutive lots used in the study.Timepoint: At Day 84 | — |
Countries
India
Contacts
Public ContactDr Ravindra Mittal
Cadila Healthcare Limited
Outcome results
None listed