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The problem
Intervention: RTS,S/AS01E malaria vaccine administered to children aged 5-17 months
Who it was tested with: African children aged 5 to 17 months; 16,976 vaccinated, 10,973 controls.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"Following initial screening, titles, abstracts, and full texts were filtered using EndNote software. Data were systematically extracted from each included study. SAEs were categorized according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The analysis focused on calculating proportions (%), risk ratios (RRs), and odds ratios (ORs) of SAEs. Pooled effect sizes and 95% confidence intervals (CIs) were derived using random-effects models from aggregated data meta-analysis." This describes a systematic review with meta-analysis of RCTs, providing experimental-level evidence for vaccine safety outcomes.
Analysis pooled data from trials; specific country data not provided. Further long-term follow-up data needed. Control arm used rabies vaccine rather than placebo.
Across countries and designs
4 studies · 3 countries
