Madrid Andalusia Overall
n=229 n=324 n=553
Age, years      
Mean (SD) 4.2 (0.20) 5.9 (0.29) 5.2 (0.89)
Gender, (n (%))[1]      
Male 103 (45.0) 161 (49.7) 264 (47.7)
Female 126 (55.0) 163 (50.3) 289 (52.3)
Concomitant vaccination, (n (%))a 227 (99.1) 4 (1.2) 231 (41.8)
Haemophilusinfluenzae type b vaccines 1 (0.4) 0 (0.0) 1 (0.4)
Measles vaccines 226 (98.7) 1 (25.0) 227 (97.4)
Meningococcal vaccines 0 (0.0) 1 (25.0) 1 (0.4)
Pneumococcal vaccines 1 (0.4) 0 (0.0) 1 (0.4)
Poliomyelitis vaccines 1 (0.4) 0 (0.0) 1 (0.4)
Varicella Zoster vaccines 0 (0) 2 (50.0) 2 (0.9)
Disease on day of inclusion, (n (%))a      
Acute disease 6 (2.6) 14 (4.3) 20 (3.6)
Chronic disease 24 (10.5) 32 (9.9) 56 (10.1)
Medication prior to inclusion[2], (n (%))a 11 (4.8) 5 (1.5) 16 (2.9)
Concomitant medication, (n (%))a 23 (10.0) 33 (10.2) 56 (10.1)
Medication used to treat ARs, (n (%))a 36 (7.0) 89 (13.5) 125 (10.6)
Medication used to treat ARs, (n (%))[3]      
Antibiotics for topical use 0 (0.0) 2 (3.2) 2 (2.1)
Antihistamines for systemic use 1 (2.9) 1 (1.6) 2 (2.1)
Antiinflammatory and antirheumatic  products, NSAIDs 21 (61.8) 51 (82.3) 72 (75.0)
Antivaricose therapy 0 (0.0) 1 (1.6) 1 (1.0)
Corticosteroids for systemic use 0 (0.0) 2 (3.2) 2 (2.1)
Corticosteroids 1 (2.9) 2 (3.2) 3 (3.1)
Other analgesics and antipyretics 10 (29.4) 3 (4.8) 13 (13.5)
Motility stimulants 1 (2.9) 0 (0.0) 1 (1.0)
SD: Standard Deviation an (%) is expressed as a percentage of the total participant analysis population. The participant analysis population or analysis set consists of all participants enrolled in the study that were compliant with inclusion/non-inclusion criteria and were therefore included in the analysis.
bRefers to medication taken in the 7 days prior to vaccination day.cn (%) is expressed as a percentage of the total number of different medications used to treat adverse events reported during the study.
Table 1: Baseline characteristics of Study Population.