Safety assessments
swelling/tenderness, myalgia, fatigue, fever, pain, headache, chills, arthralgia
ADVERSE REACTIONS, ADVERSE EVENTS
Safety endpoints included solicited local and systemic adverse reactions (ARs) for 7 days after vaccination, safety laboratory abnormalities (Part 1 only), unsolicited adverse events (AEs) for 28 days after vaccination, as well as serious AEs (SAEs), AEs of special interest (AESIs), and medically attended AEs (MAAEs) through the end of the study (Day 181). Interim safety data through Day 29 are included in this report. Participants used an electronic diary to record local ARs (ie, injection site pain, injection site redness, injection site hardness, or axillary swelling/tenderness ipsilateral to the side of injection), or systemic ARs (ie, headache, fatigue, myalgia, arthralgia, nausea/vomiting, chills, and fever). Safety laboratory assessments in Part 1 (at baseline and Day 8) included white blood cell count, hemoglobin, platelets, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, and creatinine.