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Collection of Protocols and Guidelines forPhase 3 study of Vaccine Candidate for COVID-19 v1

Article scientifique 2020 Anglais

Résumé

This is a collection of protocols for: "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.

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Ockenhouse, C., Gast, C., Holt, R., Flores, J. (2020). Collection of Protocols and Guidelines forPhase 3 study of Vaccine Candidate for COVID-19 v1. https://doi.org/10.17504/protocols.io.bj5pkq5n

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Auteur(s)

Chris Ockenhouse Chris Gast Renée Holt Jorge Flores

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