Prevention of neurobehavioural impairments in children exposed to falciparum malaria infection Infections and Infestations
Conditions
Interventions
The malaria vaccine follow-up study will be conducted by researchers from KEMRI research Centre in Kilifi county, in a defined area that undergoes routine monitoring of births, migrations deaths and e
Sponsors
KEMRI-Wellcome Trust Research Programme
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All children who participated in phase II (in Kilifi) and III (in Kombewa and Siaya) of the RTS,S/ASO1 trial study and were included in the intention-to-treat population or analysis. Intention-to-treat population is chosen to allow analysis of the impact of number of doses received for vaccine 2. Participants of the ITN intervention trial who give written informed consent to participate in the follow-up studies of neurodevelopment and school participation
Exclusion criteria
Exclusion criteria: 1. Children who will not have been included in the intention-to treat population or analysis in the RTS, S/AS01 trial study to facilitate analysis of the impact of number of doses received for vaccine on neurobehavioral outcomes 2. Children who will not have been included in the ITN intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of neurobehavioral impairments assessed using a battery of standardised neuropsychological measures 10 years after vaccination and 26 years after administration of the preventative interventions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in school participation i.e. enrollment rates, school performance and cases of absenteeism assessed using parental and children questionnaires 10 years after vaccination and 26 years after administration of the preventative interventions. | — |
Countries
Kenya
Outcome results
None listed