Malaria Paediatrics
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ¿ A male or female between, and including, 2 and 6 years of age at the time of the first vaccination. ¿Written informed consent obtained from the subject¿s parents. ¿Free of obvious health problems as established by medical history and clinical examination before entering into the study. ¿Availability for the duration of the immunization and follow-up period.
Exclusion criteria
Exclusion criteria: ¿Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness. ¿Severe malnutrition, defined as weight-for-height z-score 130mmol/L ¿Serum ALT concentration >69 IU/L ¿Blood transfusion within one month of enrolment. ¿History of vaccination with previous experimental malaria vaccines. ¿Administration of any other vaccine or immunoglobulin within two weeks before vaccination. ¿Current participation in another clinical trial, or within 12 weeks of this study. ¿Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial. ¿Likelihood of travel away from the study area. ¿HIV positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ¿Occurrence of solicited events after each vaccination ;¿Occurrence of unsolicited symptoms after each vaccination ;¿Occurrence of solicited events after each vaccination ;¿Occurrence of unsolicited symptoms after each vaccination | — |
Countries
Gambia
Contacts
Programme Manager