Complete physical examinations will be performed on the following body systems: general appearance, signs and symptoms (including, but not limited to the head and neck, eyes and ears, nose and throat, chest, lungs, heart, abdomen, extremities and joints, lymph nodes, skin, and neurological). Moreover, diagnoses, Karnofsky score, height, weight and vital signs will be registered. Finally , skin observation will be performed. At Screening, if an abnormal condition is detected, the condition will be described on the medical history CRF. At study visits, if a new abnormal or worsened abnormal pre- existing condition is detected, the condition will be described on the AE CRF. If the abnormal value was not deemed an AE because it was due to an error, due to a preexisting disease (described in Section 8.1.6), not clinically significant, a symptom of a new/worsened condition already recorded as an AE, or due t o another issue that will be specified, the investigator will record the justification on the source record. At Visits 3 and 5, a targeted physical examination including vital signs should be driven by any new or previously identified signs and symptoms that the subject has experienced since the last visit. 6.7.7 Vital Signs Vital sign values (including seated blood pressure, pulse, respirations, and oral temperature) are to be measured at every visit as part of the complete and targeted physical examinations, and recorded on the CRF. At Day 1, measurement of vital signs must be performed in two occasions: before vaccination and 1 hour after last vaccination. For each abnormal vital sign value, the investigator will determine whether to report an AE (see definit ion in Section 8.1.1 and record the medical diagnosis [ preferably ], symptom, or sign on the AE CRF) to the Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 53 of 81 CONFIDENTIAL safety review team. Additional tests and other evaluations required to establish the significance or etiology of an abnormal value, or to monitor the course of an AE should be obtained when clinically indicated.