2005
DOI: 10.1590/s0034-89102005000300012
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Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial

Abstract: OBJECTIVE: To compare the reactogenicity of three yellow fever (YF) vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots) and placebo. METHODS: The study involved 1,087 adults eligible for YF vaccine in Rio de Janeiro, Brazil. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered ("day 0") following standardized procedures adapted to allow blinding and blocked randomization of participants to coded vaccine types. Adverse events after immunization were ascer… Show more

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Cited by 41 publications
(21 citation statements)
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“…No significant difference in age, body mass index, gender, and ethnicity were found between those with or without AEs (Table 1). Overall, our published AE rates were comparable to the previously reported AE rates following YFLAV administration (21%-72%), depending on the study design (11)(12)(13)(14)(15). Using the distribution of fever onset as a guide, as it has been shown to be a significant AE in those who received YFLAV compared with placebo (11), we divided the AEs into immediate or delayed based on whether the AE onset occurred before or after 24 hours after vaccination ( Figure 2, A-C).…”
Section: Resultssupporting
confidence: 88%
“…No significant difference in age, body mass index, gender, and ethnicity were found between those with or without AEs (Table 1). Overall, our published AE rates were comparable to the previously reported AE rates following YFLAV administration (21%-72%), depending on the study design (11)(12)(13)(14)(15). Using the distribution of fever onset as a guide, as it has been shown to be a significant AE in those who received YFLAV compared with placebo (11), we divided the AEs into immediate or delayed based on whether the AE onset occurred before or after 24 hours after vaccination ( Figure 2, A-C).…”
Section: Resultssupporting
confidence: 88%
“…Rates of 15 to 18% of vaccinees experiencing local reactions and approximately 30% reporting solicited systemic reactions were consistent with other published reports. [15][16][17] The overall occurrence of severe local and systemic adverse reactions in our study population, 2 to 2.5%, was very low. In addition, these rates of occurrence of severe adverse reactions further decreased in the cohort of subjects 60 years of age and older.…”
Section: Discussionmentioning
confidence: 60%
“…Normally, an excess risk of adverse events resulting from vaccination is most accurately estimated by comparison to a placebo, as reported recently in Brazil. 17 In that study, comparing the 17DD, 17D-213 and placebo, an excess of 3.5 to 7.4% for all adverse events was noted in vaccine recipients.…”
Section: Discussionmentioning
confidence: 88%
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