Template protocol for clinical trials investigating vaccines—Focus on safety elements
Template protocol for clinical trials investigating vaccines—Focus on safety elements
About this item
Full title
Author / Creator
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 , for the Brighton Collaboration Clinical Trial Protocol Working Group and Brighton Collaboration Clinical Trial Protocol Working Group
Publisher
Kidlington: Elsevier Ltd
Journal title
Language
English
Formats
Publication information
Publisher
Kidlington: Elsevier Ltd
Subjects
More information
Scope and Contents
Contents
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 st...
Alternative Titles
Full title
Template protocol for clinical trials investigating vaccines—Focus on safety elements
Authors, Artists and Contributors
Author / Creator
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
for the Brighton Collaboration Clinical Trial Protocol Working Group
Brighton Collaboration Clinical Trial Protocol Working Group
Identifiers
Primary Identifiers
Record Identifier
TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4586124
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4586124
Other Identifiers
ISSN
0264-410X,1873-2518
E-ISSN
1873-2518
DOI
10.1016/j.vaccine.2013.02.041
