Pooled analysis of safety data from pediatric phase II RTS,S/AS malaria candidate vaccine trials

Johan Vekemans, Yolanda Guerra, Marc Lievens, Sarah Benns, Didier Lapierre, Amanda Leach, Thomas Verstraeten

    Research output: Contribution to journalArticle

    Abstract

    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.
    Original languageEnglish
    Pages (from-to)1309-1316
    Number of pages8
    JournalHuman Vaccines
    Volume7
    Issue number12
    DOIs
    Publication statusPublished - 2011

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    Vekemans, J., Guerra, Y., Lievens, M., Benns, S., Lapierre, D., Leach, A., & Verstraeten, T. (2011). Pooled analysis of safety data from pediatric phase II RTS,S/AS malaria candidate vaccine trials. Human Vaccines, 7(12), 1309-1316. https://doi.org/10.4161/hv.7.12.18046