Malaria
Conditions
Interventions
RTSS AS01E Malaria vaccine
RTSS AS01E Malaria Vaccine
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants must satisfy ALL the following criteria at study entry: 1. Healthy male or female participants aged 5 to 60 months at the time of the first vaccination, who have previously completed the WHO Expanded Programme on Immunization (EPI) vaccinations or for younger infants have received all required vaccinations at point of recruitment according to the schedule for the country where the study is conducted. 2. Participants’ parent(s)/Legally Acceptable Representative(s) (LAR), in the opinion of the investigator, can and will comply with the requirements of the protocol (eg, completion of the diaries, returning for follow-up visits). 3. Written or witnessed/thumb-printed informed consent obtained from the participant’s parent(s)/LAR prior to performance of any study-specific procedure. 4. Healthy, as established by medical history and clinical examination* *Malaria blood films will be performed at baseline (and at all immunogenicity visits), but if asymptomatic, this would not be an exclusion criterion. However, all participants with asymptomatic parasitemia will be managed as per local guidelines. 5. Negative for human immunodeficiency virus (HIV), HBV, and hepatitis C virus (HCV) 6. With hemoglobin levels >8 g/dL. 7. Born after a gestation period of =37 weeks.
Exclusion criteria
Exclusion criteria: 1. Progressive, unstable, or uncontrolled clinical conditions. 2. History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine. 3. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 4. Clinical conditions representing a contraindication to IM vaccination or blood draws. 5. Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant’s ability to participate in the study. 6. Recurrent history of or uncontrolled neurological disorders or seizures. 7. Undernutrition, defined as WHO Z-score less than –2 standard deviation. 8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant as a result of participation in the study, for example, any major congenital defects. 9. Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history. 10. Administration of long-acting immune-modifying drugs (eg, infliximab) during the study period starting 3 months before the first dose of study vaccine or planned administration during the study period. 11. Prior receipt of a malaria vaccine (registered or experimental). 12. Use of any investigational or non-registered product (drug, vaccine, or medical device)* other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day –30 to Day 1), or planned use during the study period. 13. Planned administration of a vaccine not foreseen by the study protocol List not exhaustive due to limited word count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the immunogenicity profile of RTS,S/AS01E when administered in different doses and schedules | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe the immunogenicity profile of RTS,S/AS01E when administered in different doses and schedules;To assess the safety and reactogenicity profile of RTS,S/AS01E for each schedule in terms of Serious Adverse Events, Adverse Events, and Adverse Events of Special Interest.;To describe the antibody response to the anti HBs for each schedule. | — |
Countries
Rwanda
Contacts
Public ContactClaudine Umuhoza
Study coordinator Center for Family Health Research
Outcome results
None listed