Screening/Baseline Assessments Clause Samples

Screening/Baseline Assessments. Participants enrolled in the main cohort will be screened for eligibility and vaccinated on Day 0. However, vaccination can be performed on a different day to screening as long as QIV vaccination falls within the required 28-day window. Participants enrolled in the immunogenicity cohort may have a separate screening visit up to 120 days before Day 0. The following will be performed at screening: • Collection of baseline information - Demographic information including age, ethnicity, gender - Height, weight - Medical history, including any allergies - Prior medications (recent [within the last 4 weeks] and currently ongoing) - Any co-morbidities • Physical examination • Description (brand) and timing of QIV received by the patient • Urine pregnancy test sensitive to 25IU human chorionic gonadotrophin (pre-vaccination on Day 0 in women of childbearing potential) Results and findings that make the participant ineligible will be discussed with the participant and they will be referred for follow-up care with their healthcare provider if necessary. Participants will not be vaccinated, or will have vaccination deferred in the event of the following; • Acute disease at the time of vaccination. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. temperature of ≤37.5°C/99.5°F • Temperature of >37.5°C (99.5°F) at the time of vaccination