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☆

11 12 2013
By Bonhoeffer, Jan ; Imoukhuede, Egeruan B. ; Aldrovandi, Grace ; ...
http://dx.doi.org/10.1016/j.vaccine.2013.02.041
Source: Vaccine. 31(47):5602-5620

[PDF-918.90 KB]

English

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Details:

Alternative Title:

Vaccine
Personal Author:

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

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 Less -
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.
Subjects:

[+]

Article Biomedical Research Clinical Trial Clinical Trials As Topic Humans Immunization Protocol Safety Vaccine Vaccines
Source:

Vaccine. 31(47):5602-5620
Pubmed ID:

23499603
Pubmed Central ID:

PMC4586124
Document Type:

Journal Article
Funding:

CC999999/ImCDC/Intramural CDC HHSUnited States/
Volume:

31
Issue:

47
Collection(s):

CDC Public Access
Main Document Checksum:

[+]

urn:sha256:b4bbd17389844f7172c70882a9784ce8ae094fde5e9041a8a4000df9d6160e69
Download URL:

https://stacks.cdc.gov/view/cdc/34540/cdc_34540_DS1.pdf
File Type:

	NIHMS723119-supplement-Supplement.docx	docx
	nihms723119.nxml	xml
	nihms723119u1.jpg	jpeg

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