Trial reportVaccine2026
Adverse events following immunization (AEFI) with fractional one-fifth and one-half doses of yellow fever vaccine compared to standard dose in children 9-23 months old in Uganda, 2019-2022 - final report.
Trial report in Vaccine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03725618 (Immunogenicity of Fractional One-fifth and One-half Doses of Yellow Fever Vaccine Compared to Full Dose in Children 9-23 Months Old), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Immunogenicity of Fractional One-fifth and One-half Doses of Yellow Fever Vaccine Compared to Full Dose in Children 9-23 Months Old
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0 citing papers in PubMed.
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Authors and funding
16 authors.
Funding
Abstract
backgroundLacking adequate safety data, the World Health Organization (WHO) recommends a full dose of yellow fever (YF) vaccine to children two years or younger. In older age groups in outbreak settings, the WHO recommends a fractional dose of YF due to vaccine shortages. Therefore, in children aged 9-23 months, we conducted a single-blind randomized controlled trial to compare the safety of fractional 1/2 and 1/5 doses of BioManguinhos 17DD YF vaccine with the full dose. This paper presents the final safety analysis for this trial.
methodsAt three study sites in Uganda, healthy children aged 9-23 months were recruited for inclusion. Data on adverse events following immunization (AEFI) was collected from March 26, 2019, to December 30, 2022, using active surveillance for 28 days post-vaccination. A diary card and a thermometer were used for the first 14 days post-vaccination. Serious adverse events (SAE) were investigated by an independent team from the Uganda AEFI committee.
results1066 (60 %) of 1770 enrolled children reported at least one non-serious adverse event (NSAE), with the most reported events being fever 610 (34 %) and diarrhea 608 (34 %). Fever and diarrhea prevalence both peaked two days post-vaccination, and fever prevalence was statistically higher in the full dose group than either fractional dose group. Thirty (1.7 %) of participants reported a SAE, with no difference by study arm; this included three SAEs reported to be vaccine product-related by the causality committee. Although six deaths occurred during the study, none were causally associated with the vaccine.
conclusionsOur study did not identify any unexpected safety issues with the YF fractional or full dose vaccine and Vaccine-related SAEs were rare. Although our study was not powered to identify associations for the safety outcomes monitored, our findings provide further evidence on the safety of YF fractional dosing in children aged 9-23 months (NCT03725618).
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