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

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. Th...

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Published inVaccine Vol. 31; no. 47; pp. 5602 - 5620
Main Authors Bonhoeffer, Jan, Imoukhuede, Egeruan B, Aldrovandi, Grace, Bachtiar, Novilia S, Chan, Eng-Soon, Chang, Soju, Chen, Robert T, Fernandopulle, Rohini, Goldenthal, Karen L, Heffelfinger, James D, Hossain, Shah, Jevaji, Indira, Khamesipour, Ali, Kochhar, Sonali, Makhene, Mamodikoe, Malkin, Elissa, Nalin, David, Prevots, Rebecca, Ramasamy, Ranjan, Sellers, Sarah, Vekemans, Johan, Walker, Kenneth B, Wilson, Pam, Wong, Virginia, Zaman, Khalequz, Heininger, Ulrich
Format Journal Article
LanguageEnglish
Published Kidlington Elsevier Ltd 12.11.2013
Elsevier
Elsevier Limited
Subjects
Allergy and Immunology
Applied microbiology
Biological and medical sciences
Biomedical Research - methods
Clinical trial
Clinical trials
Clinical Trials as Topic
Collaboration
Decision making
Fundamental and applied biological sciences. Psychology
guidelines
human health and safety
Humans
Immunization
Microbiology
Protocol
Public health
Safety
safety testing
Vaccine
vaccines
Vaccines - administration & dosage
Vaccines - adverse effects
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Low and Middle Income Country
Independent Ethics Committee
FDA
DSMB
Central Safety Physician
Data and Safety Monitoring Board
International Conference on Harmonization
Institutional Review Board
The Independent Data Monitoring Committee
IDMC
Clinical trial
Safety
Protocol
CIOMS
Adverse Event Following Immunization
United States Food and Drug Administration
WHO
CSP
Immunization
Case Report Form
World Health Organization
IEC
LSM
Local Safety Monitor
Vaccine
NIH
ICF
Informed Consent Form
ICH
Serious Adverse Event
GCP
SOP
CRF
United States National Institutes of Health
SAE
IRB
LMIC
AEFI
Standard Operation Procedure
Good Clinical Practice
Council for International Organizations of Medical Sciences
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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.
AbstractList 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.
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.
Author Zaman, Khalequz
Heininger, Ulrich
Makhene, Mamodikoe
Wong, Virginia
Khamesipour, Ali
Imoukhuede, Egeruan B
Malkin, Elissa
Sellers, Sarah
Fernandopulle, Rohini
Wilson, Pam
Aldrovandi, Grace
Goldenthal, Karen L
Kochhar, Sonali
Vekemans, Johan
Jevaji, Indira
Walker, Kenneth B
Bachtiar, Novilia S
Chang, Soju
Nalin, David
Heffelfinger, James D
Bonhoeffer, Jan
Prevots, Rebecca
Chen, Robert T
Chan, Eng-Soon
Hossain, Shah
Ramasamy, Ranjan
AuthorAffiliation a University Children’s Hospital (UKBB), University of Basel, Basel, Switzerland
b European Vaccine Initiative, Heidelberg, Germany
m MedImmune, LLC, USA
g Centers of Disease Control and Prevention, USA
e Sanofipasteur, Canada
h University of Colombo, Sri Lanka
t Department of Paediatrics and Adolescent Medicine, The University of Hong Kong, Hong Kong, China
f National Institutes of Health, USA
i Independent Consultant, Bethesda, MD, USA
k Tehran University of Medical Sciences, Iran
n Consultant in vaccinology, PA, USA
c The Saban Research Institute Children’s Hospital Los Angeles, USA
s Harvard Clinical Research Institute, Boston MA
q Glaxo Smith Kline, Belgium
d Bio Farma, Indonesia
o Institute of Health Sciences, Universiti Brunei Darussalam, Brunei Darussalam
j National Institute of Communicable Diseases, India
r Health Protection Agency, UK
u International Centre for Diarrhoeal Disease Research, Bangladesh
l International AIDS Vaccine Initiative, India
p q-Vigilance, LLC, USA
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ContentType Journal Article
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Guerra-Mendoza, Yolanda
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Macete, Eusebio
Chakraborty, Rana
Costa, Christopher T da
Guishard, Stephane
Brown, Arthur E
Hennig, Renald
Thole, Jelle
Gidudu, Jane
Rosenthal, Steven
Zuber, Patrick
Genton, Blaise
MacDonald, Noni
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Black, Steve
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Deville, Jaime G
Kulcsár, Andrea
Macina, Denis
de Freitas, Fabiana
Patwardhan, Moreshwar
Nell, Patricia
Josey, Cassandra N
Sutherland, Andrea
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de Souza Brito, Glacus
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Copyright Elsevier Ltd
2013 Elsevier Ltd
2015 INIST-CNRS
Copyright © 2013 Elsevier Ltd. All rights reserved.
Copyright Elsevier Limited Nov 12, 2013
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CorporateAuthor for the Brighton Collaboration Clinical Trial Protocol Working Group
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Issue 47
Keywords Low and Middle Income Country
Independent Ethics Committee
FDA
DSMB
Central Safety Physician
Data and Safety Monitoring Board
International Conference on Harmonization
Institutional Review Board
The Independent Data Monitoring Committee
IDMC
Clinical trial
Safety
Protocol
CIOMS
Adverse Event Following Immunization
United States Food and Drug Administration
WHO
CSP
Immunization
Case Report Form
World Health Organization
IEC
LSM
Local Safety Monitor
Vaccine
NIH
ICF
Informed Consent Form
ICH
Serious Adverse Event
GCP
SOP
CRF
United States National Institutes of Health
SAE
IRB
LMIC
AEFI
Standard Operation Procedure
Good Clinical Practice
Council for International Organizations of Medical Sciences
Language English
License CC BY 4.0
Copyright © 2013 Elsevier Ltd. All rights reserved.
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Notes http://dx.doi.org/10.1016/j.vaccine.2013.02.041
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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.
OpenAccessLink https://doi.org/10.1016/j.vaccine.2013.02.041
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Snippet 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...
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...
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...
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SourceType Open Access Repository
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StartPage 5602
SubjectTerms Allergy and Immunology
Applied microbiology
Biological and medical sciences
Biomedical Research - methods
Clinical trial
Clinical trials
Clinical Trials as Topic
Collaboration
Decision making
Fundamental and applied biological sciences. Psychology
guidelines
human health and safety
Humans
Immunization
Microbiology
Protocol
Public health
Safety
safety testing
Vaccine
vaccines
Vaccines - administration & dosage
Vaccines - adverse effects
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
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Title Template protocol for clinical trials investigating vaccines—Focus on safety elements
URI https://www.clinicalkey.es/playcontent/1-s2.0-S0264410X13002302
https://dx.doi.org/10.1016/j.vaccine.2013.02.041
https://www.ncbi.nlm.nih.gov/pubmed/23499603
https://www.proquest.com/docview/1615789008/abstract/
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Volume 31
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