Related Experiment Video
Updated: May 27, 2026
An Improved and High Throughput Respiratory Syncytial Virus (RSV) Micro-neutralization Assay
Published on: January 26, 2019
Pooled analysis of safety data from pediatric Phase II RTS,S/AS malaria candidate vaccine trials
Johan Vekemans1, Yolanda Guerra, Marc Lievens
1GlaxoSmithKline Biologicals, Wavre, Belgium. johan.vekemans@gskbio.com
Insights
RTS,S/AS malaria vaccine showed mild side effects like URTI and rash in children under 5. No significant increase in serious adverse events was observed, suggesting a favorable safety profile.
Area of Science:
- Pediatric infectious diseases
- Vaccine safety and efficacy
- Clinical immunology
Background:
- The RTS,S/AS malaria vaccine underwent Phase II clinical trials.
- Assessing vaccine safety is critical before large-scale deployment.
Purpose of the Study:
- To evaluate the safety profile of the RTS,S/AS malaria vaccine in children under 5 years old.
- To analyze pooled safety data from Phase II trials.
Main Methods:
- A pooled analysis of safety data from 2981 children under 5 years old.
- 8860 doses of RTS,S/AS vaccine were administered.
- Adverse events, including serious adverse events (SAEs), were monitored.
Main Results:
- Increased rates of non-serious upper respiratory tract infections (URTI), rash, and diaper dermatitis were observed.
- No significant increase in overall or single serious adverse events (SAEs).
- Two cases of febrile seizures were possibly vaccine-related, with decreased relative risks for death and SAEs.
Conclusions:
- The RTS,S/AS vaccine demonstrated a favorable risk-benefit balance in young children.
- Further confirmation of safety and efficacy is ongoing in Phase III 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.
