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Vaccine. 2013 Nov 12;31(47):5602-20. doi: 10.1016/j.vaccine.2013.02.041. Epub 2013 Mar 13.

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

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University Children's Hospital (UKBB), University of Basel, Basel, Switzerland. Electronic address:


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.


AEFI; Adverse Event Following Immunization; CIOMS; CRF; CSP; Case Report Form; Central Safety Physician; Clinical trial; Council for International Organizations of Medical Sciences; DSMB; Data and Safety Monitoring Board; FDA; GCP; Good Clinical Practice; ICF; ICH; IDMC; IEC; IRB; Immunization; Independent Ethics Committee; Informed Consent Form; Institutional Review Board; International Conference on Harmonization; LMIC; LSM; Local Safety Monitor; Low and Middle Income Country; NIH; Protocol; SAE; SOP; Safety; Serious Adverse Event; Standard Operation Procedure; The Independent Data Monitoring Committee; United States Food and Drug Administration; United States National Institutes of Health; Vaccine; WHO; World Health Organization

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