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

• Published in: Vaccine 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
• Language: English
• 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
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2013.02.041

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.