Common use of Solicited Adverse Events Clause in Contracts

Solicited Adverse Events. Solicited adverse events are events the participant is specifically asked about. These adverse events are commonly observed soon after receipt of vaccines and relate to local and systemic signs and symptoms. Solicited adverse events will be collected for 7 days post-vaccination1. These will be recorded daily in the eDiary for all participants. Participants in the immunogenicity cohort will also have an in-clinic assessment on Day 7 (+3 days). Solicited adverse events will also be reviewed during the telephone calls on Day 1 (+2 days) (all participants) and Day 7 (+3 days) (main cohort only). For this study, solicited adverse events to be collected include: • Vaccination site reactions: pain, induration, warmth, erythema (redness) • Systemic adverse events: feverishness, chills, myalgia, fatigue, headache, nausea, arthralgia, malaise 1 In the event that they persist longer than 7 days then an adverse event will be recorded Participants will be asked to record the presence of these symptoms and grade the severity as described in Section 5.3.1. Oral temperature will be measured using the thermometer provided and the diameter of induration will be measured with the tape measure provided.