None listed
Conditions
Interventions
Intervention1: ZyCoV-D - Novel Corona Virus-2019-nCov vaccine of M/s. Zydus Lifesciences Limited: Subject will be administered single dose of 3mg once during the study. 3mg dose of ZyCoVD consists of
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects (healthy / high risk) of either gender =18 years of age 2. Subjects who have received 2 doses on Covaxin or Covishield with last dose 6 (+1) months prior to screening date 3. Informed consent from subjects 4. Subjects literate enough to fill the diary card 5. 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 followup visit and males who agree to use contraception
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. History or laboratory evidence of confirmed SARS-CoV-2 infection after primary vaccination or RTPCR positive for COVID-19 at the time of screening 3. Subjects who have received one or two doses of any approved or experimental COVID-19 vaccine other than Covaxin or Covishield in past. 4. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days 5. History of SARS/ MERS infection 6. Past history of hypersensitivity reaction or any serious adverse event after any vaccination 7. Subjects with known history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy 8. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy 9. Clinically significant (uncontrolled) 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 8 weeks after enrolment (upto day 56 of study) 12. Participation in another clinical trial in the past 3 months 13. Pregnant and lactating women 14. History of drug / alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To establish non-inferiority of single 3mg booster dose of ZyCoV-D as compared to Homologous booster (Covaxin) in terms of seroconversion rate (IgG by ELISA and NAB) in subjects who have received Covaxin as primary vaccination 2. To establish non-inferiority of single 3mg booster dose of ZyCoV-D as compared to Homologous booster (Covishield) in terms of seroconversion rate (IgG by ELISA and NAB) in subjects who have received Covishield as primary vaccinationTimepoint: Day 0, Day 28 and Day 168 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events (solicited, unsolicited and SAEs) reported during the study ZyCoV-D and homologous booster (Covaxin / Covishield)Timepoint: Throughout the Study;1. To establish non-inferiority of single 3mg booster dose of ZyCoV-D as compared to homologous booster (Covaxin / Covishield) in terms of GMTs of IgG by ELISA and NAB 2. To compare the long term persistence of IgG antibodies against S1 antigen (by ELISA) at and Neutralizing antibodies 24 weeks after booster dose (Seroconversion rate and GMTs) with ZyCoV-D and homologous booster (Covaxin / Covishield) 3. To compare cellular response after booster dose with ZyCoV-D and homologous booster (Covaxin / Covishield) Timepoint: Day 0, Day 28 and Day 168 | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Zydus Lifesciences Limited (Formerly Known as Cadila Healthcare Limited)
Outcome results
None listed