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

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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
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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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

TY - JOUR

T1 - Pooled analysis of safety data from pediatric phase II RTS,S/AS malaria candidate vaccine trials

AU - Vekemans, Johan

AU - Guerra, Yolanda

AU - Lievens, Marc

AU - Benns, Sarah

AU - Lapierre, Didier

AU - Leach, Amanda

AU - Verstraeten, Thomas

PY - 2011

Y1 - 2011

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AB - 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.

U2 - 10.4161/hv.7.12.18046

DO - 10.4161/hv.7.12.18046

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SP - 1309

EP - 1316

JO - Human Vaccines

JF - Human Vaccines

SN - 1554-8600

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ER -