Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Perceptions of acceptability of seasonal RTS,S/AS01 vaccination |
Perceptions of acceptability of seasonal RTS,S/AS01 vaccination, in addition to, or as a replacement for SMC to those who receive it, and those who deliver it. |
Data collection via in-depth interviews and focus group discussions in Year 1 and Year 2 |
|
Other |
Perceptions of feasibility of seasonal RTS,S/AS01 vaccination |
Perceptions of policy makers and health programme deliverers of the feasibility of introducing seasonal RTS,S/AS01 vaccination into the current health systems, either in addition to, or as a replacement for SMC. |
Data collection via in-depth interviews and focus groups discussions in Year 1 and Year 2 |
|
Primary |
Incidence of clinical episodes of malaria |
Passive surveillance to detect episode of fever (temperature > 37.5 C), or a history of fever within the past 48 hours, that is severe enough to require treatment at a health centre and which is accompanied by a positive blood film with a parasite density of 5,000 per µl or more |
Passive surveillance of clinical episodes of malaria within the study area starting 4 weeks post 6th dose of vaccination (1 July 2020) until 31 March 2022. |
|
Secondary |
Clinical episodes of uncomplicated febrile illness |
Passive and active surveillance to detect cases with temperature > 37.5o C), or a history of fever within the past 48 hours, with a positive blood film (any level of asexual parasitaemia) or a positive rapid diagnostic test (RDT) for malaria |
Passive surveillance in all health centers within the study area 4 weeks post primary vaccination (1 July 2020) until 31 March 2022. |
|
Secondary |
Hospital admissions with malaria, including severe malaria |
Hospital admissions with malaria, including cases of severe malaria which meet WHO criteria for a diagnosis of severe malaria. |
Through study completion, each child admitted in a study hospital will be treated and monitored until complete cure or death (a period of 2 years). Documentation of each hospital admission according to ICH-GCP |
|
Secondary |
Prevalence of malaria infection not severe enough to warrant a clinic visit |
Active surveillance of malaria at household level to assess the prevalence of malaria infection not severe enough to warrant a clinic visit detected in a subset of randomly selected children. |
Weekly home visits through study completion from 1 July 2020 - 31 March 2022 to screen study children for malaria. |
|
Secondary |
Prevalence of malaria parasitaemia, including gametocytaemia and the prevalence of moderate and severe anemia and malnutrition |
The prevalence of malaria parasitaemia, including gametocytaemia, moderate and severe anaemia and malnutrition at the end of the malaria transmission season |
Blood sample collection during 2-week cross sectional survey at the end of each malaria transmission season (November 2020/21).). |
|
Secondary |
Serious adverse events (SAEs) |
Serious adverse events (SAEs), including any deaths, occurring at any time during the study with special reference to any cases of meningitis and cerebral malaria (WHO case definition) |
Through study completion (for 2 years), each SAE will be treated and documented according to ICH-GCP. |
|
Secondary |
Immune response to the vaccine (anti-CSP antibody concentrations) |
Anti-CSP antibody concentrations obtained before and after each booster dose, determined in a sub-sample of children. |
Blood sample collection 0-7 days before and one month after the booster doses (year 1 and 2). |
|
Secondary |
Prevalence of malaria parasitaemia in school aged children |
The prevalence of malaria parasitaemia at the end of each malaria transmission season in school-age children resident in the study areas, to determine overall malaria transmission |
Blood sample collection during the 2-week cross sectional survey at the end of each malaria transmission season (November 2020/21). |
|
Secondary |
Polymorphisms in the P. falciparum CSP |
The prevalence of mutations in the Th2 or Th3 locus of the Plasmodium falciparum csp gene in isolates from children who have received RTS,S/AS01 that differ from those of the isolate used in the preparation of the vaccine |
Blood sample collection from children with clinical episodes of malaria and in children with parasitaemia at the 2-week cross-sectional survey (November 2020/21)). |
|
Secondary |
Drug resistance to SP and AQ |
The presence of molecular markers of resistance to SP and AQ in parasite positive samples |
Blood sample collection during the final 2-week cross sectional survey conducted at the end of malaria transmission season (November 2021) |
|
Secondary |
SP+AQ drug sensitivity |
The 28-day treatment outcome in children with asymptomatic malaria parasitaemia treated with SP+AQ. |
Children with asymptomatic malaria parasitaemia identified during the final cross-sectional survey (November 2021), treated with a full course of SP+AQ over 3 days and followed for 28 days. |
|
Secondary |
'Rebound' malaria |
Incidence of uncomplicated malaria and hospitalisation for severe malaria in study children who have reached the age of five years at the time of the last year of the trial and who are no longer eligible to receive either of the trial interventions |
Passive surveillance of uncomplicated and severe cases of malaria in hospitals and clinics within the study area during the 4 month (July- October) 2021 transmission season. |
|