Study Flow Diagram. Abbreviations: AEs=adverse events; eDiary=electronic diary; ILI=influenza-like illness; SAE=serious adverse event The majority of participants will participate in the main cohort of the study. These participants will attend the clinic for a single screening/vaccination visit on Day 0 and will be followed up over the duration of the influenza season into which they are recruited. Approximately 50 participants will participate in an immunogenicity cohort; it is anticipated this will be at one centre only. In addition to the visits and procedures outlined for the main cohort, these participants will attend for a further three clinic visits on Days 7(+3 days) and 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season). Following screening and confirmation of eligibility on Day 0, all participants will be randomised in a 1:1 ratio to the two treatment groups shown in Table 2-1. Participants in the immunogenicity cohort only will also have pre-vaccination safety laboratory and immunogenicity blood samples taken. Table 2-1 Treatment Groups and Number of Participants Group 1 Group 2 Study treatments MVA-NP+M1 Placebo Dose 1.5 x 108 pfu None Volume 0.5 mL 0.5 mL Route of administration Intramuscular injection Intramuscular injection Vaccination days Day 0 Day 0 Number of participants; 2500-3000 2500-3000 Main cohort 2475 2475 Immunogenicity cohort 25 25 Vaccinations (1.5 x 108 pfu MVA-NP+M1 or saline placebo) will be administered by intramuscular injection using the Z-track technique on Day 0. Participants will be observed for at least 30 minutes post-vaccination in case of immediate adverse events and to comply with GMO licence regulations. All participants will be provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home. Participants will record their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination. Participants will be asked to record whether or not they have a respiratory illness and / or ILI every week during the influenza season, starting on 01 May and ending on or before 15 October in line with official Australian influenza season. Respiratory illness or Influenza Like Illness (ILI) for this protocol that triggers a nasal swab collection (to maximize the likelihood of recovering virus positive samples) is defined as the presence of one or more of the following symptoms; feve...
Study Flow Diagram. Total number of patients randomised and compliant (>70% medication use) per treatment group. At each stage of the study (0, 6 and 30 months) the numbers are listed of those who underwent bronchoscopy amongst the number of patients remaining in the study. Definition of abbreviations: n = number. Short-term therapy with ICS Table 1. Patient characteristics at baseline * * Values are means (SDs) unless otherwise indicated. † By analysis of variance or Kruskall-Wallis tests between groups. || Range of 1 to 5 (a higher score indicates more dyspnea). ¶ Range of 0 (best) to 100 (worst). ** Range of 0 (best) to 6 (worst). Long-term continuation of ICS therapy
