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 journalArticleResearchpeer-review

    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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    Diaper Rash
    Malaria Vaccines
    Febrile Seizures
    Dermatitis
    Malaria
    Pneumonia
    Vaccination
    Pediatrics
    Safety

    Cite this

    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
    Vekemans, Johan ; Guerra, Yolanda ; Lievens, Marc ; Benns, Sarah ; Lapierre, Didier ; Leach, Amanda ; Verstraeten, Thomas. / Pooled analysis of safety data from pediatric phase II RTS,S/AS malaria candidate vaccine trials. In: Human Vaccines. 2011 ; Vol. 7, No. 12. pp. 1309-1316.
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    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.",
    author = "Johan Vekemans and Yolanda Guerra and Marc Lievens and Sarah Benns and Didier Lapierre and Amanda Leach and Thomas Verstraeten",
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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, vol. 7, no. 12, pp. 1309-1316. https://doi.org/10.4161/hv.7.12.18046

    Pooled analysis of safety data from pediatric phase II RTS,S/AS malaria candidate vaccine trials. / Vekemans, Johan; Guerra, Yolanda; Lievens, Marc; Benns, Sarah; Lapierre, Didier; Leach, Amanda; Verstraeten, Thomas.

    In: Human Vaccines, Vol. 7, No. 12, 2011, p. 1309-1316.

    Research output: Contribution to journalArticleResearchpeer-review

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    AU - Guerra, Yolanda

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    AU - Lapierre, Didier

    AU - Leach, Amanda

    AU - Verstraeten, Thomas

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