COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=65971

Dr Prasad Kulkarni

drpsk@seruminstitute.com

2022-04-21

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Adults aged more than or equal to 18 years of either sex <br/ >2. Written informed consent by participants <br/ >3. Those who have completed primary COVID-19 vaccination schedule with at least 6 months ago <br/ >4. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration

1. Acute illness at the time of screening <br/ >2. History of laboratory confirmed COVID-19 <br/ >3. History of allergic reactions after previous vaccinations including primary vaccination for COVID-19 <br/ >4. Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw <br/ >5. Suspected or known current alcohol or drug dependence <br/ >6. Chronic administration of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period <br/ >7. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period <br/ >8. Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine for until 28 days after study vaccination <br/ >9. Prior receipt of a booster dose of COVID-19 vaccine <br/ >10. Pregnant or breast-feeding <br/ >11. Acute or chronic, clinically significant systemic disorders <br/ >12. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the participant in the study or make it unlikely that the participant could complete the protocol

3

Serum Institute of India Private Limited Pune

18

100

India

Healthy volunteers

N/A

372

Anti-S IgG and Neutralizing antibodiesTimepoint: 28 days after vaccination

| Declared number of arm (4.0) differs from found arms (5.0)

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": 1158, "treatment_name": "Sars-cov-2 rs/matrix-m1 adjuvant", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]