Resource Summary Report  New Search Previous Search Results

URL: https://dx.doi.org/10.17504/protocols.io.bj5xkq7n

Authors: Chris Ockenhouse, Chris Gast, Renee Holt, Jorge Flores

Group: Coronavirus Method Development Community

Summary: This is Part 4 of "Phase 3 randomized, double-blinded, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of Vaccine Candidate against COVID-19 in adults > 18 years of age"This generic Phase 3 protocol was developed by the PATH team with support of the Bill and Melinda Gates Foundation. The aim of the collection is to share recommended best practices in designing and implementing a Phase 3 study of a COVID-19 vaccine candidate. As Phase 3 trials of different Vaccine Candidates proceed around the world, following the same protocols will ensure consistency and comparability of the Phase 3 trial results.Please note that this is an evolving document, to be versioned and updated, based on community feedback and new data.

Affiliations: Center for Vaccine Innovation and Access, PATH (Washington D.C. and Seattle, Washington), Center for Vaccine Innovation and Access, PATH (Washington D.C. and Seattle, Washington), Center for Vaccine Innovation and Access, PATH (Washington D.C. and Seattle, Washington), Center for Vaccine Innovation and Access, PATH (Washington D.C. and Seattle, Washington)

Version: 1

Publication Date: 2020

Expand All Collapse