Vaccine
Volume 31, Issue 47, Pages 5495-5622 (12 November 2013)
http://www.sciencedirect.com/science/journal/0264410X/31/47

Template protocol for clinical trials investigating vaccines—Focus on safety elements
Original Research Article
Pages 5602-5620
Jan Bonhoeffer, Egeruan B. Imoukhuede, Grace Aldrovandi, Novilia S. Bachtiar, Eng-Soon Chan, Soju Chang, Robert T. Chen, Rohini Fernandopulle, Karen L. Goldenthal, James D. Heffelfinger, Shah Hossain, Indira Jevaji, Ali Khamesipour, Sonali Kochhar, Mamodikoe Makhene, Elissa Malkin, David Nalin, Rebecca Prevots, Ranjan Ramasamy, Sarah Sellers, et al.

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.