Inclusion criteria
Item
Did the subject meet all the entry criteria?
boolean
C1512693 (UMLS CUI [1])
Gender, first vaccination, age
Item
male or female between, and including, 6 and 16 weeks of age (between 42 and 118 days) at the time of the first vaccination. Pre-term born infants (born after a gestation period of less than 37 weeks) can be included in the study starting from 8 weeks of chronological age at the time of first vaccination and up to 16 weeks of chronological age (between 56 and 118 days).
boolean
C0079399 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0151526 (UMLS CUI [4,1])
C1272684 (UMLS CUI [4,2])
living area covered by surveillance for CAP, ID, AOM
Item
In each site, subjects should be living in the area covered by the surveillance system for CAP, ID and AOM (see country specific LPPs).
boolean
C0237096 (UMLS CUI [1,1])
C0733511 (UMLS CUI [1,2])
C0733511 (UMLS CUI [2,1])
C0694549 (UMLS CUI [2,2])
C0733511 (UMLS CUI [3,1])
C4285937 (UMLS CUI [3,2])
C0733511 (UMLS CUI [4,1])
C0029882 (UMLS CUI [4,2])
C0205178 (UMLS CUI [4,3])
Informed consent obtained from the parent or guardian of the subject.
Item
Written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Health problems contraindicate the initiation of routine immunizations
Item
Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
boolean
C0332296 (UMLS CUI [1,1])
C1446390 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
C0020971 (UMLS CUI [1,4])
Protocol compliance parents/guardians
Item
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Use or planned drug use of any investigational or non-registered
Item
Use of any investigational or non-registered drug or planned use during the study period.
boolean
C0521116 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Use or planned use of any investigational or non-registered vaccine
Item
Use or planned use of any investigational or non-registered vaccine other than the study vaccine(s).
boolean
C0521116 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
C1517586 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0332300 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0042210 (UMLS CUI [3,3])
C1507394 (UMLS CUI [3,4])
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or S. pneumoniae.
Item
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or S. pneumoniae.
boolean
C0042196 (UMLS CUI [1,1])
C0012546 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0039614 (UMLS CUI [2,2])
C0042196 (UMLS CUI [3,1])
C0043167 (UMLS CUI [3,2])
C0042196 (UMLS CUI [4,1])
C0121772 (UMLS CUI [4,2])
C0042196 (UMLS CUI [5,1])
C0019159 (UMLS CUI [5,2])
C0042196 (UMLS CUI [6,1])
C0038410 (UMLS CUI [6,2])
Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar.
Item
Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar.
boolean
C0205156 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0358314 (UMLS CUI [1,3])
C0042196 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0358314 (UMLS CUI [2,3])
C0205156 (UMLS CUI [3,1])
C0042196 (UMLS CUI [3,2])
C0876134 (UMLS CUI [3,3])
C0042196 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0876134 (UMLS CUI [4,3])
Allergic disease/reactions exacerbated by any component of the vaccines.
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
C2106654 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
C1507394 (UMLS CUI [1,5])
History of any neurologic disorders or seizures.
Item
History of any neurologic disorders or seizures.
boolean
C0262926 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0036572 (UMLS CUI [2,2])
Acute disease (defined as the presence of a moderate or severe illness with or without fever)
Item
Acute disease at the time of enrolment (Acute disease is defined as the presence of a moderate or severe illness with or without fever).
boolean
C0001314 (UMLS CUI [1])
Low birth weight
Item
Infants with low birth weight (<2.500g) (Amended 25 November 2008).
boolean
C0021288 (UMLS CUI [1])