COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57878

Dr Pratibha Kale

drpratibhapgi@gmail.com

2022-01-25

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

Healthy volunteers above 18 years who have received 2 doses of ChAdOx1 nCoV-19 vaccine <br/ > Able and willing to comply with study requirements <br/ > Willing to refrain from blood donation during the study period <br/ > giving consent <br/ >

Anaphylactic reaction following administration of vaccine previously <br/ > Pregnant or lactating women <br/ > Any adverse event that in the opinion of the Investigator may affect the safety of the participant or the interpretation of the study results <br/ > Subject not giving consent <br/ > Individuals who have received any other COVID1-9 vaccine <br/ > <br/ > <br/ >

2

Institute of Liver and Biliary Sciences

18

80

India

Healthy volunteers

N/A

180

Assess efficacy and immunogenicity of the booster dose of ChAdOx1 nCoV-19 (COVISHIELD) against COVID-19 in vaccine recipients compared to the placebo groupTimepoint: 6 months

Phase 3

[{"arm_notes": "", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]