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

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

doi:10.1016/j.vaccine.2013.02.041

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

Published Date:

Mar 13 2013

Publisher's site:

http://dx.doi.org/10.1016/j.vaccine.2013.02.041

Source:

Vaccine. 31(47):5602-5620.

[PDF-918.90 KB]

Details:

Alternative Title:

Vaccine

Personal Author:

Bonhoeffer, Jan ; Imoukhuede, Egeruan B. ; Aldrovandi, Grace ; Bachtiar, Novilia S. ; Chan, Eng-Soon ; ... More ▼

Description:

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.

Subject:

[+]

Pubmed ID:

23499603

Pubmed Central ID:

PMC4586124

Document Type:

Journal Article

Funding:

CC999999/Intramural CDC HHS/United States

Collection(s):

CDC Public Access

Main Document Checksum:

[+]

Supporting Files:

	NIHMS723119-supplement-Supplement.docx	application/vnd.openxmlformats-officedocument.wordprocessingml.document
	nihms723119.nxml	application/octet-stream
	nihms723119u1.jpg	image/jpeg

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