Template protocol for clinical trials investigating vaccines—Focus on safety elements

doi:10.1016/j.vaccine.2013.02.041

Vaccine

Volume 31, Issue 47, 12 November 2013, Pages 5602-5620

https://doi.org/10.1016/j.vaccine.2013.02.041 Get rights and content

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.

Abbreviations

AEFI

Adverse Event Following Immunization

CIOMS

Council for International Organizations of Medical Sciences

CRF

Case Report Form

CSP

Central Safety Physician

DSMB

Data and Safety Monitoring Board

FDA

United States Food and Drug Administration

GCP

Good Clinical Practice

ICF

Informed Consent Form

ICH

International Conference on Harmonization

IDMC

The Independent Data Monitoring Committee

IEC

Independent Ethics Committee

IRB

Institutional Review Board

LMIC

Low and Middle Income Country

LSM

Local Safety Monitor

NIH

United States National Institutes of Health

SAE

Serious Adverse Event

SOP

Standard Operation Procedure

WHO

World Health Organization

Keywords

Vaccine

Immunization

Safety

Protocol

Clinical trial

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^☆: Disclaimer: The findings, opinions, and assertions contained in this consensus document are those of the individual scientific professional members of the working group. They do not necessarily represent the official positions of each participant's organization (e.g., government, university, or corporations). Specifically, the findings and conclusions in this paper are those of the authors and do not necessarily represent the views of the US National Institutes of Health (NIH) and the Centers of Disease Control and Prevention (CDC).

¹: Further members of the Brighton Collaboration Clinical Trial Protocol Working Group: Ananda Amarasinghe, Allan M. Arbeter, Immanuel Bath, Steve Black, Kalifa Bojang, Arthur E. Brown, Rana Chakraborty, Elena Chiappini, Christopher T. da Costa, Jaime G. Deville, Glacus de Souza Brito, Fabiana de Freitas, Blaise Genton, Jane Gidudu, Roxana Mansour Ghanaie, Yolanda Guerra-Mendoza, Stephane Guishard, Renald Hennig, Nathalie Imbault, Cassandra N. Josey, Andrea Kulcsár, Xavier Kurz, Noni MacDonald, Denis Macina, Eusebio Macete, Samuel J. McConkey, Zsofia Meszner, Vasee Moorthy, Patricia Nell, Moreshwar Patwardhan, Steven Rosenthal, Andrea Sutherland, Cindy Tamminga, Jelle Thole, Vytautas Usonis, Frederick Varricchio, Beverly A. Warden, Patrick Zuber.

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Vaccine

Template protocol for clinical trials investigating vaccines—Focus on safety elements☆

Abstract

Abbreviations

Keywords