Key result
RTS,S/AS malaria candidate vaccine was associated with increased rates of mild/moderate URTI, rash, and diaper dermatitis, but significantly decreased relative risks of death and any SAE.
Why the study?
Does the RTS,S/AS malaria candidate vaccine have a favorable safety profile in children under 5 years old?
Meta-Analysis (n=2,981)
Does the RTS,S/AS malaria candidate vaccine have a favorable safety profile in children under 5 years old?
The RTS,S/AS malaria candidate vaccine demonstrates a favorable safety profile in children under 5, with no increase in serious adverse events and a decreased risk of death.
Supports RTS,S/AS deployment in children under 5; confirms favorable safety profile across pooled trials.
Prior to progression to Clinical Development Phase III, GlaxoSmithKline Biologicals performed a pooled analysis of phase two safety data following administration of 8860 doses of RTS,S/AS to 2981 children under 5 years old. RTS,S/AS was associated with increased rates of non-serious URTI, rash and diaper dermatitis graded mild or moderate. There was no significant increased rate of overall or single SAEs. Two episodes of simple febrile seizure were estimated to be related to vaccination. Significant decreased relative risks of death, any SAE, any SAE excluding malaria and pneumonia were observed. The results suggest a favourable risk-benefit balance which is to be confirmed in the ongoing Phase III trials.
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Vekemans et al. (2011) conducted a meta-analysis in Malaria (n=2,981). RTS,S/AS malaria candidate vaccine was evaluated on Safety (SAEs, death, URTI, rash, diaper dermatitis). RTS,S/AS malaria candidate vaccine was associated with increased rates of mild/moderate URTI, rash, and diaper dermatitis, but significantly decreased relative risks of death and any SAE.
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