Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled studyResearch in context

Summary: Background: NVX-CoV2373, a Covid-19 vaccine was developed in the USA with ∼90% efficacy. The same vaccine is manufactured in India after technology transfer (called as SII-NVX-CoV2373), was evaluated in this phase 2/3 immuno-bridging study. Methods: This was an observer-blind, randomised,...

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Autors principals:	Prasad S. Kulkarni, Abhijit Kadam, Sheela Godbole, Varsha Bhatt, Abhishek Raut, Sunil Kohli, Santanu Tripathi, Praveen Kulkarni, Rakhi Ludam, Madhav Prabhu, Ashish Bavdekar, Nithya J. Gogtay, Sushant Meshram, Tamilarasu Kadhiravan, Sonali Kar, D.H. Ashwath Narayana, Clarence Samuel, Govind Kulkarni, Abhay Gaidhane, Dipu Sathyapalan, Sidram Raut, Vijay Hadda, Hira Lal Bhalla, Chetanraj Bhamare, Abhijeet Dharmadhikari, Joyce S. Plested, Shane Cloney-Clarke, Mingzhu Zhu, Melinda Pryor, Stephanie Hamilton, Madhuri Thakar, Ashwini Shete, Manish Gautam, Nivedita Gupta, Samiran Panda, Umesh Shaligram, Cyrus S. Poonawalla, Balram Bhargava, Bhagwat Gunale, Dhananjay Kapse, Shubhangi A. Kanitkar, Arjun L. Kakrani, Srikanth P. Tripathy, Abhijit V. Tilak, Akshay A. Dhamne, Shahzad Beg Mirza, Prachi V. Athavale, Mandakini Bhowmik, Parag J. Ratnakar, Subodh Gupta, Vijayshri Deotale, Jyoti Jain, Ashwini Kalantri, Vineet Jain, Nidhi Goyal, Alok Arya, Temsunaro Rongsen-Chandola, Shreyasi Dasgupta, Pratibha Periera, Vanmathi A, Anand Kawade, Arunkumar Gondhali, Palvi Kudyar, Abhishek Singh, Ravi Yadav, Alina Alexander, Venugopalan Gunasekaran, Sekar Dineshbabu, P.C. Samantaray, H.S. Ravish, Deepshikha Kamra, Shilpa Gaidhane, Quazi Syed Zahiruddin, Merlin Moni, Anil Kumar, Ameet Dravid, Anant Mohan, Tejas Suri, Tejas K. Patel, Surekha Kishore, Rahul Choche, Deepak Ghatage, Sugam Salvi
Format:	Artigo
Idioma:	Inglês
Publicat:	Elsevier 2023-03-01
Col·lecció:	The Lancet Regional Health - Southeast Asia
Matèries:	SII-NVX-CoV2373 NVX-CoV2373 Safety Immunogenicity Non-inferiority
Accés en línia:	http://www.sciencedirect.com/science/article/pii/S2772368222001561
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