Compliance of Child
Item
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
boolean
C1321605 (UMLS CUI [1,1])
C0008059 (UMLS CUI [1,2])
Age
Item
A male or female 18-24 months of age at the time of the booster vaccination.
boolean
C0001779 (UMLS CUI [1])
undefined item
Item
Subjects must have completed full three-dose primary vaccination course with InfanrixTMhexa in the study 217744/090 (DTPa-HBV-IPV-090).
text
Informed consent
Item
Written informed consent obtained from the parent or guardian of the subject before study entry.
boolean
C0021430 (UMLS CUI [1])
Comorbidity, Medical history
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study
boolean
C0262926 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
other medication during study
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster vaccination, or planned use during the study period.
boolean
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib
Item
Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination since the study conclusion visit of study DTPa-HBV-IPV-090.
boolean
C0121772 (UMLS CUI [1])
C0012546 (UMLS CUI [2])
C0039614 (UMLS CUI [3])
C0043167 (UMLS CUI [4])
C0032371 (UMLS CUI [5])
Evidence of previous or intercurrent, diphtheria, tetanus, pertussis hepatitis B, polio and/or Hib disease
Item
Evidence of previous or intercurrent, diphtheria, tetanus, pertussis hepatitis B, polio and/or Hib disease.
boolean
C0121772 (UMLS CUI [1])
C0012546 (UMLS CUI [2])
C0039614 (UMLS CUI [3])
C0043167 (UMLS CUI [4])
C0032371 (UMLS CUI [5])
immunosuppressive or immunodeficient condition, HIV
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C0021079 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
other vaccine
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol within the 30 days preceding the booster dose.
boolean
C2368628 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
immunoglobulins and/or any blood products
Item
(Planned) administration of immunoglobulins and/or any blood products during the study period starting 3 months before and ending 30 days after the booster vaccination.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
immunosuppressants or other immune-modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Seizures or progressive neurological disease
Item
History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
boolean
C0027765 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
C0036572 (UMLS CUI [2])
Major congenital defects or serious chronic illness.
Item
Major congenital defects or serious chronic illness.
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Acute febrile illness
Item
Acute febrile illness (axillary temperature of ! 37.5°) at the time of planned vaccination (warrants deferral of the vaccination pending recovery of the subject).
boolean
C0743842 (UMLS CUI [1])
medical history of hypersensitivity
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
former adverse reactions to DTP vaccine
Item
Any of the following adverse events having occurred after previous administration of DTP vaccine constitute a contraindication to the administration of the vaccine: - Hypersensitivity reaction due to the vaccine. - Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. - Fever ! 40 °C (axillary temperature) within 48 hours of vaccination. - Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination. - Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
boolean
C0012559 (UMLS CUI [1,1])
C0559546 (UMLS CUI [1,2])
C0012559 (UMLS CUI [2,1])
C1301624 (UMLS CUI [2,2])