Clinical assessments
myalgia, fever, fatigue, toxicity, erythema, pain, dizziness, nausea,, headache, tenderness, chills, arthralgia
ADVERSE EVENTS, ERYTHEMA, INJECTION SITE SWELLING, REACTOGENICITY, EVENTS
Reactogenicity was measured from the time of each study vaccination (study days 1, 57, 113) through 7 days after each study vaccination by the occurrence of solicited injection site and systemic reactogenicity events. Solicited symptoms included erythema, induration/swelling, pain, and tenderness as injection site reactions; and fever, chills, myalgia, arthralgia, nausea, vomiting, headache, dizziness, malaise, and fatigue as systemic reactions.Unsolicited adverse events (AEs) were recorded from the time of each vaccination through 28 days after each study product administration. New-onset chronic medical conditions (NOCMCs), including AEs of special interest (AESI), and serious AEs (SAEs) were recorded from the time of the first study vaccination (day 1) through the final study visit. Active surveillance for AESIs of autoimmune (Participants were observed in the study clinic for at least 60 minutes after vaccination to assess immediate reactogenicity. They were subsequently assessed at 1, 3, 7, 14, and 28 days after each vaccination, and then at regular intervals until 12 months after the third injection. AEs were assigned severity of mild (easily tolerated), moderate (interfered with activities of daily living), or severe (prevented activities of daily living); causality in relation to study product was determined based on investigator judgement. Injection site swelling and erythema were assessed as small (25 to 50 mm in diameter), medium (51 to 100 mm), or large (>100 mm); whereas oral temperature was graded as mild (38.0°C to 38.4°C), moderate (38.5°C to 38.9°C), or severe (≥39.0°C).Clinical laboratory evaluations were performed on the day of vaccination and 7 days later to measure alanine aminotransferase (ALT), creatinine, and complete blood count (CBC) including hemoglobin (Hgb), platelets, and white blood cells (WBC). Abnormal safety laboratory test results were assessed as mild, moderate, or severe according to standardized toxicity tables [