An Evaluation of the Pilot Implementation of RTS,S/AS01 Through Routine Health Systems in Moderate to High Malaria Transmission Settings in Africa (Malaria Vaccine Pilot Evaluation ( MVPE ))

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Community mortality surveillance and sentinel hospital surveillance

Study drug and medical condition

• Name of medicine:
  MOSQUIRIX
• Medical condition to be studied:
  Meningitis bacterial

  Malaria

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
• Estimated number of subjects:
  960000

Study design details

• Main study objective:
  To estimate the effect of RTS,S introduction on: • impact (on all-cause mortality (excluding accidents) and severe malaria • safety cerebral malaria, meningitis and gender specific mortality • feasibility of delivering a four dose malaria schedule
• Outcomes:
  To estimate the effect of RTS,S introduction on: • on all-cause mortality (excluding accidents) • hospital admission with severe malaria (severe malaria anaemia or cerebral malaria) • hospital admission with probable or confirmed meningitis (pooled) • hospital admission with cerebral malaria (pooled) • gender specific mortality, To estimate the effect of RTS,S introduction on: • all-cause and malaria specific mortality • incidence of (i) all cause hospital admission, (ii) admission with severe malaria anaemia and requirement for transfusion,(iii) admission with cerebral malaria, (iv) non malaria hospital admission • routine vaccine uptake, malaria and other childhood interventions and health seeking behavior
• Data analysis plan:
  Children will not be assigned individual identifiers at the time of vaccination and there will be no systematic linkage between records of children admitted to participating hospitals and records of children vaccinated with RTS,S/AS01 or any other vaccine. The effect of RTS,S/AS01 will therefore be assessed by comparing incidence in vaccine-eligible age groups, in populations where the malaria vaccine was introduced and populations in comparator areas. Effects will be measured in terms of the incidence rate ratio (the relative increase or decrease in incidence of the outcome due to introduction of RTS,S vaccine, in the age group of children eligible to receive the vaccine) as a result of RTSS vaccine being introduced into an area, in the age groups of children eligible for the vaccine, expressed per 1000 child years or other suitable units). As a secondary analysis, rate ratios will also be estimated in children known to have received DTP3.