Safety
death, hyperpigmentation, swelling, fatigue, muscle aches/myalgia, diarrhea, fever, rash, pain, headache, nausea,, chills
HYPERPIGMENTATION, ADVERSE EVENTS, INDURATION, INJECTION SITE REACTION, EVENTS
SAEs evaluated throughout the study were any events resulting in death or were life-threatening, required hospitalization, and/or resulted in a persistent incapacity that disrupted normal life. General health and clinical laboratory assessments—complete blood counts (CBC) with differential for white blood cell (WBC), hemoglobin, absolute neutrophil count (ANC), platelets, creatinine, albumin, total bilirubin, alanine transaminase (ALT), aspartate aminotransferase (AST), C-reactive protein (CRP), and antibodies against HBsAg, HIV and HCV—were performed during screening before vaccination, and on Day 8 post-vaccination for serum chemistry and hematology. Solicited local injection site reactions were pain, erythema/redness, swelling, induration and hyperpigmentation for the two IPV arms, and solicited systemic adverse events were chills, fatigue, headache, muscle aches/myalgia, joint ache/arthralgia, rash, nausea, vomiting, diarrhea, and fever defined as an oral temperature ≥ 38.0 °C for all participants. Unsolicited adverse events were reported from Day 1 to Day 57. Solicited and unsolicited AEs were graded for severity on a scale of 0 (normal), 1 (mild), 2 (moderate), and 3 (severe).