title: 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.
authors.affiliation: University Children's Hospital (UKBB), University of Basel, Basel, Switzerland. Electronic address: contact@brightoncollaboration.org.
authors.forename: Jan
authors.initials: J
authors.lastname: Bonhoeffer
authors.forename: Egeruan B
authors.initials: EB
authors.lastname: Imoukhuede
authors.forename: Grace
authors.initials: G
authors.lastname: Aldrovandi
authors.forename: Novilia S
authors.initials: NS
authors.lastname: Bachtiar
authors.forename: Eng-Soon
authors.initials: ES
authors.lastname: Chan
authors.forename: Soju
authors.initials: S
authors.lastname: Chang
authors.forename: Robert T
authors.initials: RT
authors.lastname: Chen
authors.forename: Rohini
authors.initials: R
authors.lastname: Fernandopulle
authors.forename: Karen L
authors.initials: KL
authors.lastname: Goldenthal
authors.forename: James D
authors.initials: JD
authors.lastname: Heffelfinger
authors.forename: Shah
authors.initials: S
authors.lastname: Hossain
authors.forename: Indira
authors.initials: I
authors.lastname: Jevaji
authors.forename: Ali
authors.initials: A
authors.lastname: Khamesipour
authors.forename: Sonali
authors.initials: S
authors.lastname: Kochhar
authors.forename: Mamodikoe
authors.initials: M
authors.lastname: Makhene
authors.forename: Elissa
authors.initials: E
authors.lastname: Malkin
authors.forename: David
authors.initials: D
authors.lastname: Nalin
authors.forename: Rebecca
authors.initials: R
authors.lastname: Prevots
authors.forename: Ranjan
authors.initials: R
authors.lastname: Ramasamy
authors.forename: Sarah
authors.initials: S
authors.lastname: Sellers
authors.forename: Johan
authors.initials: J
authors.lastname: Vekemans
authors.forename: Kenneth B
authors.initials: KB
authors.lastname: Walker
authors.forename: Pam
authors.initials: P
authors.lastname: Wilson
authors.forename: Virginia
authors.initials: V
authors.lastname: Wong
authors.forename: Khalequz
authors.initials: K
authors.lastname: Zaman
authors.forename: Ulrich
authors.initials: U
authors.lastname: Heininger
mesh_terms: D035843:Biomedical Research / Q000379:methods*; D002986:Clinical Trials as Topic; D006801:Humans; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D014612:Vaccines
keywords: 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