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Template protocol for clinical trials investigating vaccines--focus on safety elements.

ABSTRACT: This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts.

SUBMITTER: Bonhoeffer J

PROVIDER: S-EPMC4586124 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Template protocol for clinical trials investigating vaccines--focus on safety elements.

Bonhoeffer Jan J Imoukhuede Egeruan B EB Aldrovandi Grace G Bachtiar Novilia S NS Chan Eng-Soon ES Chang Soju S Chen Robert T RT Fernandopulle Rohini R Goldenthal Karen L KL Heffelfinger James D JD Hossain Shah S Jevaji Indira I Khamesipour Ali A Kochhar Sonali S Makhene Mamodikoe M Malkin Elissa E Nalin David D Prevots Rebecca R Ramasamy Ranjan R Sellers Sarah S Vekemans Johan J Walker Kenneth B KB Wilson Pam P Wong Virginia V Zaman Khalequz K Heininger Ulrich U

Vaccine 20130313 47

This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. ...[more]

PMID: 23499603

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