Journal
VACCINE
Volume 35, Issue 27, Pages 3452-3456Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2017.05.003
Keywords
Adverse events following immunization; Clinical trial; Dengue; Immunization; Safety; Vaccine
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Funding
- Sanofi Pasteur
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A new dengue vaccine was associated with increased risk of hospitalized virologically-confirmed disease during year 3 of follow-up among children age 2-5 years. Among hypotheses to explain this finding, we could not distinguish definitively between antibody dependent enhancement, waning immunity, or chance occurrence. However, any theory must account for the following: (a) the signal occurred mainly because of decreased dengue among controls rather than increased dengue among vaccinees; (b) among 48 data points, a statistically significant increase in hospitalization among vaccinated children occurred for only one age group, during one year, and in one region; (c) cumulative risk was similar for vaccinated vs. control children age 2-5 years at the end of year 5 and lower for vaccinated vs. control children among older age groups; (d) the protective effect of vaccine against hospitalization decreased from years 1-2 to years 3-5 of follow-up for all age groups and regions. (C) 2017 The Author(s). Published by Elsevier Ltd.
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