Response to influenza vaccine of children with and without asymptomatic malaria parasitemia. Infections and Infestations
Conditions
Interventions
The trial will enroll a total of 1300 children from approximately 30 rural villages in Chikhwawa District, in Southern Malawi, where each village has about 100-150 households . The study will enroll p
participants’ immunological response to the vaccine will be assessed at Days 28 and 56. Malaria parasitaemia will be assessed in participants at each study visit.
Study subjects will b
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 6 to 59 months 2. Resident in study village for the past 12 months (or since birth if less than 12 months old) 3. Is not currently enrolled in another intervention study 4. Parent/guardian provides informed consent by signature or thumb print
Exclusion criteria
Exclusion criteria: 1. History of allergic reaction to any component of the study vaccines 2. History of allergic reaction to egg 3. History of bleeding disorders 4. History of Guillain-Barré Syndrome 5. Residence outside the study area or planning to relocate out in the 3 months following enrolment 6. Used immunosuppressive medication within 45 days of study entry (inhaled and topical corticosteroids permitted) 7. Received immunoglobulin or blood products within 45 days of study entry 8. Parent/guardian unable to give informed consent (for example due to mental disability) 9. Temperature 37.5°C or higher Axillary/38°C Oral or reported fever (prior 48 hours) on the day of vaccination 10. Acutely ill (respiratory symptoms, diarrhoea or vomiting within the past 24 hours) 11. Influenza vaccination in previous 12 months 12. Weigh less than 5 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity is measured using blood sampling at baseline (prior to immunisation) and at 28 and 56 days after the initial immunisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the immunisation is determined by recording the number and percentage of solicited and un-solicited AEs occurring within 7 days of vaccination as reported by parents/guardians in a diary card and at a check-up appointment on day 3 and day 31. | — |
Countries
Malawi
Outcome results
None listed