Table 2 Inclusion and exclusion criteria

Inclusion criteria

Male and female children aged 6-12 weeks or 5-17 months at time of first vaccination

Children in 6-12 week age category must be more than 28 days old at screening and must not have received previous vaccination against diphtheria, tetanus, pertussis or Hemophilus influenzae type B

Exclusion criteria

Acute disease at time of enrolment

Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality

Major congenital defect

Malnutrition requiring hospitalization

Hb ≤8 g/dL with clinical signs of heart failure or severe respiratory distress OR Hb ≤5 g/dL

Currently meeting WHO criteria for stage III or IV severity HIV disease

History of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunizations

History of allergic disease or reactions likely to exacerbated by any component of the vaccine

History of a neurological disorder or atypical febrile seizure

Concurrently participating in another clinical study of a drug or vaccine unlicensed for that indication, except studies aiming to improve treatment or management of severe malaria

Use of a drug or vaccine unlicensed for that indication other than study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period

Previous participation in another malaria vaccine trial

Receipt of a vaccine within the preceding 7 days

Other factors that the investigator considers would increase the risk of an adverse outcome or result in incomplete or poor quality data