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Pooled analysis of safety data from pediatric Phase II RTS,S/AS malaria candidate vaccine trials
- Source :
- Human Vaccines. 7:1309-1316
- Publication Year :
- 2011
- Publisher :
- Informa UK Limited, 2011.
-
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.
- Subjects :
- medicine.medical_specialty
Diaper Dermatitis
Plasmodium falciparum
Immunology
Clinical Trials, Phase II as Topic
Internal medicine
Malaria Vaccines
parasitic diseases
medicine
Humans
Malaria, Falciparum
General Pharmacology, Toxicology and Pharmaceutics
business.industry
Vaccination
RTS,S
Infant
medicine.disease
Rash
Surgery
Pneumonia
Treatment Outcome
Pooled analysis
Child, Preschool
Relative risk
medicine.symptom
business
Malaria
Subjects
Details
- ISSN :
- 15548619 and 15548600
- Volume :
- 7
- Database :
- OpenAIRE
- Journal :
- Human Vaccines
- Accession number :
- edsair.doi.dedup.....8db3fd3b0c25e4412fa0def73ad11d48