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Randomized Controlled Trial
. 2018 May 18;217(suppl_1):S24-S32.
doi: 10.1093/infdis/jiy042.

Monitoring Serious Adverse Events in the Sierra Leone Trial to Introduce a Vaccine Against Ebola

Olamide D Jarrett  1 , Jane F Seward  1 , Augustin E Fombah  2 , Robert Lindblad  3 , Mohamed I Jalloh  2 , Jill El-Khorazaty  3 , Peter Dawson  3 , Deron Burton  1 , Jane Zucker  1 , Wendy Carr  1 , Mohamed M Bah  2 , Gibrilla F Deen  2 , Peter M George  2 , Faustine James  2 , Durodami R Lisk  2 , Dudley Pratt  2 , James B W Russell  2 , Jibao D Sandy  2 , Patrick Turay  2 , Mary J Hamel  1 , Stephanie J Schrag  1 , Robert E Walker  4 , Mohamed Samai  2 , Susan T Goldstein  1
Affiliations
Randomized Controlled Trial

Monitoring Serious Adverse Events in the Sierra Leone Trial to Introduce a Vaccine Against Ebola

Olamide D Jarrett et al. J Infect Dis. .

Abstract

ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

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Figures

Figure 1.
Figure 1.
Safety reporting for adverse events (AEs) and serious AEs (SAEs) in the Sierra Leone Trial to Introduce a Vaccine Against Ebola.
See this image and copyright information in PMC

References

    1. World Health Organization (WHO). Ebola response roadmap update. Geneva: WHO, 2014.
    1. World Health Organization(WHO). Meeting summary of the WHO consultation on potential Ebola therapies and vaccines. Geneva: WHO, 2014.
    1. Samai M, Seward JF, Goldstein ST, et al. . The Sierra Leone Trial to Introduce a Vaccine Against Ebola—an evaluation of rVSV∆G-ZEBOV-GP vaccine tolerability and safety during the West Africa Ebola outbreak. J Infect Dis 2018; 217;s6–15. - PMC - PubMed
    1. Widdowson MA, Schrag SJ, Carter RJ, et al. . Implementing an Ebola vaccine study —Sierra Leone. MMWR Suppl 2016; 65:98–106. - PubMed
    1. Guidance for Industry and Investigators. Safety reporting requirements for INDs and BA/BE studies. Silver Spring, MD: Food and Drug Administration, 2012.

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