COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=70639

Dr Jayesh Sanmukhani

jayeshsanmukhani@zyduslife.com

2022-06-20

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

1. Subjects (healthy / high risk) of either gender â?¥18 years of age <br/ >2. Subjects who have received 2 doses on Covaxin or Covishield with last dose 6 (+1) <br/ >months prior to screening date <br/ >3. Informed consent from subjects <br/ >4. Subjects literate enough to fill the diary card <br/ >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

1. Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within <br/ >4 weeks of enrolment <br/ >2. History or laboratory evidence of confirmed SARS-CoV-2 infection after primary <br/ >vaccination or RTPCR positive for COVID-19 at the time of screening <br/ >3. Subjects who have received one or two doses of any approved or experimental <br/ >COVID-19 vaccine other than Covaxin or Covishield in past. <br/ >4. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >5. History of SARS/ MERS infection <br/ >6. Past history of hypersensitivity reaction or any serious adverse event after any <br/ >vaccination <br/ >7. Subjects with known history of thrombocytopenia or any coagulation disorder, or <br/ >subjects on anticoagulation therapy <br/ >8. Subjects with confirmed or suspected immunosuppressive or immunodeficiency <br/ >disorder, or subjects on any immunosuppressive or immunostimulant therapy <br/ >9. Clinically significant (uncontrolled) systemic disorder such as cardiovascular, <br/ >respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, <br/ >psychiatric or immunological disorder <br/ >10. Subjects administered blood, blood containing products or immunoglobulins within the <br/ >last 3 months or planned administration during the study <br/ >11. Any other vaccine administration within the last 30 days or planned to be administered <br/ >during 8 weeks after enrolment (upto day 56 of study) <br/ >12. Participation in another clinical trial in the past 3 months <br/ >13. Pregnant and lactating women <br/ >14. History of drug / alcohol abuse

3

Zydus Lifesciences Limited

18

99

India

Healthy volunteers

N/A

576

1. To establish non-inferiority of single 3mg booster dose of ZyCoV-D as compared to <br/ >Homologous booster (Covaxin) in terms of seroconversion rate (IgG by ELISA and <br/ >NAB) in subjects who have received Covaxin as primary vaccination <br/ >2. To establish non-inferiority of single 3mg booster dose of ZyCoV-D as compared to <br/ >Homologous booster (Covishield) in terms of seroconversion rate (IgG by ELISA and <br/ >NAB) in subjects who have received Covishield as primary vaccinationTimepoint: Day 0; Day 28 and Day 168

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "", "treatment_id": 1387, "treatment_name": "Covaxin", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1400, "treatment_name": "Zycov-d", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}]