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