There were no withdrawals related to an adverse event. An additional 9 enrolled subjects did not receive a vaccine due to withdrawal of consent (n = 7), inappropriate enrollment (n = 1) or inability to obtain baseline serology (n = 1); all subjects who received a dose of
the vaccine were included in the safety analysis to the extent that data were available. A total of 279 participants (including the 9 participants JQ1 cell line who were unvaccinated) were excluded from the per-protocol immunogenicity analysis. The main reason for exclusion was a missing prevaccination (n = 60) or postvaccination (n = 130) specimen. Ten subjects who received the wrong vaccine product were excluded from the immunogenicity analysis but included “as treated” in the safety analysis. Local or systemic adverse events after vaccination with
a single dose of MenACWY-CRM or MCV4 were common, reported by 60% and 51%, respectively (Table 3a and Table 3b). Erythema and pain were the most commonly reported injection-site reactions in both the 2–5 and 6–10 years age groups; in the 2–5 years age group, there were no differences between the vaccines. In the 6–10 years age group, significantly fewer participants reported pain after MenACWY-CRM than MCV4 (39% vs. 45%; p = 0.039). In contrast, fewer MCV4 than MenACWY-CRM recipients reported injection-site erythema (22% vs. 28%; p = 0.017). Severe pain or erythema >100 mm in the 6–10 years age group was unusual postvaccination with non significant trends toward higher rates of erythema post-MenACWY-CRM and pain post-MCV4. Rates of systemic adverse events were similar in recipients of MenACWY-CRM and MCV4 (Table Ulixertinib 3a and Table 3b). In the 2–5-year-old children, irritability was the most common reported systemic adverse event (21% and 22%, respectively), followed by sleepiness (16% and 18%, respectively);
fever ≥38 °C was only reported by 2% of participants. very Headache was the most common systemic adverse event in the 6–10-year-old children, reported by 18% of MenACWY-CRM recipients and 13% of MCV4 recipients (p = 0.049). There were no differences between the groups for any other systemic adverse events. Most adverse events in the 2–5 and 6–10 years age groups were reported as mild; rates of severe adverse events never exceeded 2% for either vaccine. There were also no differences between the groups in the rates of non solicited adverse events between the MenACWY-CRM (26%) and the MCV4 (24%) groups (data not shown). Most of these adverse events (10% and 11%, respectively) were related to minor intercurrent infectious diseases such as upper respiratory tract infection. An adverse event was reported by 72% of two-dose recipients, likely reflecting receipt of an additional dose and thus two seven-day observation periods. In the two-dose group, adverse events were reported less frequently after the second dose (47%) compared to the first dose (63%).