title: Pooled analysis of safety data from pediatric Phase II RTS,S/AS malaria candidate vaccine trials.
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.
authors: GlaxoSmithKline Biologicals, Wavre, Belgium. johan.vekemans@gskbio.com
authors: Johan
authors: J
authors: Vekemans
authors: Yolanda
authors: Y
authors: Guerra
authors: Marc
authors: M
authors: Lievens
authors: Sarah
authors: S
authors: Benns
authors: Didier
authors: D
authors: Lapierre
authors: Amanda
authors: A
authors: Leach
authors: Thomas
authors: T
authors: Verstraeten
mesh_terms: D002675:Child, Preschool; D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D007223:Infant; D017780:Malaria Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D016778:Malaria, Falciparum / Q000276:immunology / Q000517:prevention & control*; D010963:Plasmodium falciparum / Q000276:immunology*; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods
chemical_list: D017780:Malaria Vaccines