Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)
Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Cluster Design
Study drug and medical condition

Name of medicine

MOSQUIRIX

Medical condition to be studied

Meningitis
Population studied

Age groups

Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)

Estimated number of subjects

45000
Study design details

Main study objective

• To estimate the incidence of adverse events of special interest (AESI) in children vaccinated with RTS,S/AS01E. • To estimate the incidence of aetiology-confirmed meningitis in children vaccinated with RTS,S/AS01E.

Setting

Specific locations in sub-Saharan Africa with moderate to high malaria transmission.
A geographically confined region equipped with a demographic surveillance system and robust infrastructure for tracking population health and vaccination programs.

Outcomes

- Incidence rates of adverse events of special interest (AESI);
- Incidence rates of aetiology-confirmed meningitis cases;
- Incidence rates of probable meningitis (final classification);
- Incidence rates of clinically suspected meningitis (final classification);
- Number of meningitis cases identified at site level (first line laboratory);
- Incidence rates of cerebral malaria cases (diagnosed by Rapid Diagnostic Test [RDT] and/or microscopy);
- Incidence rates of malaria episodes diagnosed by RDT and/or microscopy;
- Incidence rates of anaemia cases at hospital entry among hospitalised children;
- Incidence rates of hospitalisation cases;
- Number of deaths.

Data analysis plan

All data analyses will be computed in a descriptive manner. Data regarding the hospitalisation will be uniformly collected whether the child is enrolled in active surveillance or in enhanced hospitalisation surveillance.