TABLE 9

AEs Reported Day 1 Through 15 After the Respective Vaccination Visit

Postvaccination 1aPostvaccination 2bPostvaccination 3b
Concomitant (Group A)cNonconcomitant (Group B) cConcomitant (Group A)cNonconcomitant (Group B) cConcomitant (Group A)cNonconcomitant (Group B) c
Subjects with follow-up, n613611591593583581
Subjects with ≥1 AE, n (%)523 (85.3)520 (85.1)307 (51.9)299 (50.4)323 (55.4)307 (52.8)
 Injection-site496 (80.9)491 (80.4)276 (46.7)276 (46.5)304 (52.1)281 (48.4)
 Systemic264 (43.1)259 (42.4)95 (16.1)89 (15.0)86 (14.8)94 (16.2)
 Seriousd1e (0.2)1f (0.2)1g (0.2)0 (0.0)1h (0.2)0 (0.0)
 Serious vaccine-related0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Discontinued due to an AE, n (%)0 (0.0)1 (0.2)1 (0.2)0 (0.0)0 (0.0)0 (0.0)
Discontinued due to death, n (%)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
  • All subjects who received ≥1 injection and had follow-up data were included in the primary analysis of safety. The number and percent of subjects reporting the following were compared between Group A and Group B: systemic AEs on days 1 through 15 after any vaccination and the number of subjects reporting clinical serious AEs from days 1 to 15 after any vaccination or vaccine-related clinical serious AE at any time during the study.

  • a Postvaccination 1 is defined as the follow-up period for safety after vaccination at day 1 and after vaccination/visit at month 1. These data represent AEs reported for the 2 vaccines combined.

  • b Because 9vHPV vaccine was the only vaccine administered in a 3-dose regimen, AEs reported postvaccination 2 and 3 would be specific to 9vHPV vaccination.

  • c Group A (concomitant administration) received a 0.5-mL dose of 9vHPV vaccine at day 1, month 2, and month 6 and a 0.5-mL dose of MCV4 and Tdap on day 1; Group B (nonconcomitant administration) received 9vHPV vaccine as Group A and MCV4 and Tdap at month 1. Two subjects randomized into the nonconcomitant group received 9vHPV vaccine at day 1 but did not receive MCV4 and Tdap at month 1 and are excluded from this table.

  • d There were 7 additional serious AE reported outside the day 1 to 15 time window. Group A: appendicitis 27 d postdose 2 of 9vHPV vaccine (5-d duration); appendicitis 93 d postdose 2 of 9vHPV vaccine (4-d duration). Group B: appendicitis 61 d postdose 1 of 9vHPV vaccine (1.3-wk duration); orthostatic hypotension 193 d postdose 1 of 9vHPV vaccine (3-d duration); depression 40-d postdose 2 of 9vHPV vaccine (3-d duration); dengue fever 47 d postdose 2 of 9vHPV vaccine (1.6-wk duration); bronchitis 127 d postdose 2 of 9vHPV vaccine (6-d duration). Thus, throughout the study period, there were 11 serious non–vaccine-related AEs reported for 10 subjects: 5 subjects (0.8%) in Group A and 5 subjects (0.8%) in Group B (1 subject experienced 2 serious AEs: gastroenteritis and orthostatic hypotension). All serious AEs were considered not related to any of the 3 study vaccines by the study investigators (investigators were instructed to assign causality to AEs on the basis of exposure, time course, likely cause, and consistency with the vaccine’s known profile; vaccine-related AEs were those that were determined by the investigator to be possibly, probably, or definitely vaccine related).

  • e Seroma 9 d postdose 1 of 9vHPV vaccine (4.3-wk duration).

  • f Gastroenteritis 6 d postdose 1 of 9vHPV vaccine (2-d duration).

  • g Affective disorder 1 d postdose 2 of 9vHPV vaccine (1.1-wk duration).

  • h Testicular torsion 8 d postdose 3 (2-d duration).