在接收每劑疫苗或安慰劑後的7天內，要求收集局部或全身不良事件，以及使用退燒藥或止痛藥。 到第二劑後1個月，參與者和自發性不良事件。在報告中，包括第二次疫苗後大約14週內的不良事件數據。英文原文如下：
The primary end points of this trial were solicited, specific local or systemic adverse events and use of antipyretic or pain medication within 7 days after the receipt of each dose of vaccine or placebo, as prompted by and recorded in an electronic diary in a subset of participants (the reactogenicity subset), and unsolicited adverse events (those reported by the participants without prompts from the electronic diary) through 1 month after the second dose and unsolicited serious adverse events through 6 months after the second dose. Adverse event data through approximately 14 weeks after the second dose are included in this report.
The most frequently reported SAEs were in the
- Cardiac Disorders SOC (0.1% in each treatment group),
- Nervous System Disorders SOC (0.1% in each treatment group), and
- Infections and Infestations SOC (0.1% in each treatment group).
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