The MVPE-CC study aims to provide additional safety and effectiveness data on the  RTS,S/AS01 malaria vaccine.

The safety question, which particularly concerns a potentially elevated risk of meningitis and cerebral malaria, and higher mortality in girls, is being addressed through a case-control design. Within the study area, individual cases are identified, alongside matched controls of similar age, sex and background. Possible risk factors (including RTS,S/AS01 vaccination) are assessed in both groups to see if any are associated with the risk of disease.

Effectiveness is being assessed by use of the case-control approach to examine any potential increase in the incidence of severe malaria in children who received three doses of RTS,S/AS01 but not the fourth dose. This will reveal any incremental value of the fourth dose and indicate whether the three-dose schedule is sufficient to give good protection.

In addition, the project is promoting the use of the case-control methodology to enable malaria control programmes more generally to monitor the safety and effectiveness of RTS,S/AS01 after introduction.