1. Enrolled and randomized Per-protocol efficacy population
LL/L*
n=1064
PSPS/PS*
n=526
Reason for exclusion†, n (%)
Did not receive second
vaccination 99 (9.3)
Received other live vaccine within 28 d of dose 18 (1.7)
Received vaccine not as
randomized 4 (0.4)
Age <6 mo or >36 mo 3 (0.3)
Followed <15 d post–dose 2 2 (0.2)
Serious chronic disease 1 (0.1)
Immunocompromised 1 (0.1)
Received other influenza
vaccine (0.1)
Received systemic
corticosteroids 1 (0.1)
vaccination 104 (9.7)
Received other live vaccine within 28 d of dose (2.0)
randomized (0.8)
Age <6 mo or >36 mo (0.2)
vaccine 4 (0.4)
Received immunoglobulin 1 (0.1)
Received incorrect vaccine
dose 1 (0.1)
vaccination 60 (11.0)
Received other live vaccine
within 28 d of dose 10 (1.8)
randomized 6 (1.1)
vaccine 1 (0.2)
Received immunoglobulin (0.2)
Subjects withdrawn, n (%) 41 (3.9)
Parent/guardian request 22 (2.1)
Lost to follow-up (1.5)
Death (0.2)
Other (0.1)
Completed
n=1023 (96.1%)
n=1033 (96.8%)
n=517 (95.2%)
n=515 (97.9%)
Per-protocol efficacy population
n=944 (88.7%)
n=935 (87.6%)
n=468 (86.2%)
n=474 (90.1%)
Subjects withdrawn, n (%) 34 (3.2)
Parent/guardian request (2.1)
Lost to follow-up (0.9) Investigator decision (0.2)
Subjects withdrawn, n (%) 26 (4.8)
Parent/guardian request 15 (2.8)
Lost to follow-up 8 (1.5) Investigator decision 2 (0.4)
Other 1 (0.2)
Subjects withdrawn, n (%) 11 (2.1)
Parent/guardian request (1.9)
Lost to follow-up 1 (0.2)
LPS/L*
n=1067
PEPE/PS*
n=543
vaccination 42 (8.0)
within 28 d of dose 10 (1.9)
randomized 1 (0.2)
Age <6 mo or >36 mo 1 (0.2)
vaccine 2 (0.4)
Received immunoglobulin (0.2) A
n=735
n=732
n=365
n=370
Subjects withdrawn, n (%) 5 (0.7)
Parent/guardian request 3 (0.4)
Lost to follow-up 1 (0.1)
Other 1 (0.1)
n=730 (99.3%)
n=721 (98.5%)
n=358 (98.1%)
n=367 (99.2%)
n=338 (46.0%)
n=684 (93.4%)
n=0 (0%)
n=342 (92.4%)
Subjects withdrawn, n (%) (1.5)
Parent/guardian request 4 (0.5)
Lost to follow-up 3 (0.4) Other 3 (0.4)
Investigator decision 1 (0.1)
Subjects withdrawn, n (%) 7 (1.9)
Lost to follow-up 2 (0.5)
Protocol violation 2 (0.5)
Other 2 (0.5)
Adverse experience 1 (0.3)
Subjects withdrawn, n (%) 3 (0.8)
Lost to follow-up 2 (0.5)
Death 1 (0.3)
randomized 372 (50.6)
Not in year 1 per-protocol
population 30 (4.1)
within 28 d of dose 23 (3.2)
population 32 (4.4)
Received other live vaccine within 28 d of dose 16 (2.1)
randomized 3 (0.4)
Followed up for <15 d postdose 1 (0.1)
randomized (100.0)
population (6.0)
Received other live vaccine within 28 d of dose (3.0)
vaccine (0.5)
randomized 4 (1.1)
population (4.6)
Received other live vaccine within 28 d of dose (3.2) B
Figure 2. A, Year 1 subject disposition, per-protocol population. B, Year 2 subject disposition, per-protocol population. L=live attenuated influenza vaccine; PE=excipient placebo; P=any placebo; PS=saline placebo. *Vaccination regimen shown as year 1 dose 1 dose 2/year 2 dose. †Subjects could be excluded for more than 1 reason.