Overall:

• No serious adverse events were noted
• No trial halting rules were met
• One participant in the 25-μg group was withdrawn because of urticaria, judged to - be related to the first vaccination
• Three participants did not receive the second vaccination

After the First Vaccination:

• 5 participants reported solicited systemic adverse events in the 25-μg group
• 10 participants reported solicited systemic adverse events in the 100-μg group
• 8 participants reported solicited systemic adverse events in the 250-μg group
• All were mild or moderate in severity

After the Second Vaccination

• 7 of 13 participants reported solicited systemic adverse events in the 25-μg group
• All 15 participants reported solicited systemic adverse events in the 100-μg group
• All 14 participants reported solicited systemic adverse events in the 250-μg group, with 3 of those participants reporting one or more severe events