The RSV-study | The Malaria-study | |
---|---|---|
Study procedures | Follow-up visits at home every 3-4 days; data from each HH member collected at each visit included: | Randomisation to one of three groups |
• Temperature, | • Experimental malaria vaccine and its booster at 1.5 years | |
• Nasopharyngeal flocked swab (NFS), | • Experimental malaria vaccine and a different | |
• Respiratory illness signs and symptoms, | • Booster dose of either Meningitis and | |
• Respiratory rate taken for all children under 5 years, | • Septicaemia vacci;ne; and | |
• Three doses of rabies vaccine plus a different booster doses of Meningitis and septicaemia; | ||
Procedures | ||
• Oral swab (taken at alternate visits (once-a-week). | • Initial physical examination, medical history, anthropometric tests, temperature. | |
• Three vaccine doses each a month apart, and | ||
A demographic and risk assessment questionnaire administered at beginning and end of the study. | • booster dose at 34 months. | |
• 5 scheduled blood samples over 3 years; each 2.5mls. | ||
• Monitoring of minor and serious adverse events; immediate post-vaccination and over time. | ||
• 6 consecutive follow-up visits post-vaccination at home. Monitoring of minor and serious adverse events. | ||
• Referral to nearest health facility for common illnesses, and to KCH for serious illnesses as advised by attending clinician. | ||
Fieldworkers roles | FWs Carried out all the study procedures at the households. | FWs Undertook the following roles: |
• Home follow-up visits to monitor minor and serious adverse events. | ||
• Where necessary, made referrals to the health facilities. | ||
• Organised for transport and food for all those attending the health facility | ||
• On rota at the local healthy facilitate to assist with anthropometric measures, temperature, and keeping of research data records | ||
• Followed-up research defaulters. |