Efficacy, safety, and lot to lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): a double-blind, randomised, controlled phase 3 trial

@inproceedings{Ella2021EfficacySA,
  title={Efficacy, safety, and lot to lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): a double-blind, randomised, controlled phase 3 trial},
  author={Raches Ella and Siddharth Reddy and William C Blackwelder and Varsha Potdar and P. Yadav and Vamshi Sarangi and Vinay Kumar Aileni and Srikanta Kanungo and S. Rai and P. Hemachandra Reddy and Savita Verma and Chandramani Singh and Sagar Redkar and Satyajit Mohapatra and Ajay Pandey and Pajanivel Ranganadin and Raghavendra Gumashta and Maneet Multani and Sameer Mohammad and Parul Bhatt and Laxmi Kumari and Gajanan N. Sapkal and Niroo Gupta and Patrick Abraham and S. Panda and Sai D. Prasad and Balram Bhargava and Krishna M Ella and Krishna Mohan Vadrevu and Covaxin Study Group},
  booktitle={medRxiv},
  year={2021}
}
Background: We report the clinical efficacy against COVID 19 infection of BBV152, a whole virion inactivated SARS CoV 2 vaccine formulated with a Toll like receptor 7/8 agonist molecule adsorbed to alum (Algel IMDG). Methods: We did a double-blind, randomised, multicentre, phase 3 clinical trial in 25 Indian hospitals to evaluate the efficacy, safety, and immunological lot consistency of BBV152. Healthy adults (age 18 to 98 years) randomised 1:1 using a sponsor-supplied randomisation scheme… Expand
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