TABLE 2

Association of Subject Characteristics With the Primary and Restrictive Outcomes Regardless of Intervention Group Adjusted for Clustering by Recruitment Center

Primary OutcomeaRestrictive Outcome
Age, y, %
 <1544.211.1
 ≥1529.05.4
P < .001P < .001
Sex, %
 Male33.27.1
 Female39.08.8
P = .01P = .11
Race and ethnicity, %
 Non-Hispanic white36.37.5
 Non-Hispanic African American37.08.5
 Hispanic35.28.5
 Other35.36.8
P = .80P = .94
BMI, %
 Normal37.87.9
 Overweight or obese34.38.2
P = .14P = .21
Passed out or nearly passed out from shot or blood draw in the past 5 y, %
 No35.47.5
 Yes47.815.1
P = .009P = .02
Hunger or thirst at the time of enrollment, %
 Not at all or a little bit35.37.2
 Very39.210.9
P = .13P = .02
Tired at the time of enrollment, %
 Not at all or a little bit35.67.8
 Very40.113.9
P = .36P = .07
Prevaccination anxiety, %
 None or slight33.96.3
 Mild, moderate, or severe40.811.5
P = .004P < .001
No. of injectable vaccines,b %
 130.65.2
 >143.711.8
P < .001P < .001
Receipt of HPV vaccine, %
 No33.87.3
 Yes38.38.5
P = .02P = .11
Pain intensity after vaccination, %
 0–131.95.1
 2–562.026.1
P < .001P < .001
  • a The primary outcome is “a little bit” or more in response to any of the 12 items on the presyncope instrument. The restrictive outcome is “somewhat” or more in response to any of the 12 items on the presyncope instrument.

  • b Including intramuscularly and subcutaneously administered vaccines.