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
View abstract on PubMed
Summary
This summary is machine-generated.This study found yellow fever (YF) fractional vaccine doses to be safe in children aged 9-23 months, with no unexpected safety issues identified. Vaccine-related serious adverse events were rare, supporting fractional YF dosing in this age group.
Area Of Science
- Pediatric infectious diseases
- Vaccinology
- Public health
Background
- The World Health Organization (WHO) recommends a full dose of yellow fever (YF) vaccine for children under two years old due to limited safety data.
- Fractional YF vaccine doses are recommended for older age groups in outbreak settings to address vaccine shortages.
- A trial was conducted to assess the safety of fractional YF vaccine doses (1/2 and 1/5) compared to a full dose in young children.
Purpose Of The Study
- To compare the safety of fractional (1/2 and 1/5 doses) versus a full dose of the BioManguinhos 17DD YF vaccine in children aged 9-23 months.
- To present the final safety analysis of a single-blind randomized controlled trial evaluating YF vaccine dosing in young children.
Main Methods
- A single-blind randomized controlled trial was conducted with 1770 healthy children aged 9-23 months across three sites in Uganda.
- Active surveillance for adverse events following immunization (AEFI) was performed for 28 days post-vaccination, including diary cards and thermometers for 14 days.
- Serious adverse events (SAEs) were investigated by an independent committee from the Uganda AEFI committee.
Main Results
- Fever and diarrhea were the most common non-serious adverse events (NSAEs), reported by 34% of participants, peaking two days post-vaccination.
- Fever prevalence was higher in the full dose group compared to fractional dose groups.
- Thirty participants (1.7%) reported SAEs, with no significant difference between study arms; three SAEs were deemed vaccine product-related by the causality committee. Six deaths occurred, none vaccine-associated.
Conclusions
- The study found no unexpected safety concerns with either fractional or full doses of the YF vaccine in children aged 9-23 months.
- Vaccine-related SAEs were infrequent, and fractional YF dosing demonstrated a favorable safety profile in this pediatric population.
- Findings support the safety of YF fractional dosing in children aged 9-23 months, though the study was not powered to detect rare safety associations.
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