Eligibility check
Did the subject meet all the entry criteria?
boolean
Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria listed below
text
Exclusion Criteria
tick "Yes" for any of the exclusion criteria that disqualified the subject from entry
text
Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.
boolean
For corticosteroids, this will mean prednisone, or equivalent >=0.5 mg/kg/day. Inhaled and topical steroids are allowed
boolean
Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
boolean
Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.
boolean
History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001
boolean
Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease
boolean
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
boolean
A family history of congenital or hereditary immunodeficiency.
boolean
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
Major congenital defects or serious chronic illness.
boolean
Subject who only had a single, uncomplicated febrile convulsion in the past can be included
boolean
Acute disease - the presence of a moderate or severe illness with or without fever; All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary t° <37.5°C/rectal t° <38°C
boolean
Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.
boolean
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
boolean
if necessary
text
one of the following AE that constitute contraindications or precaution to further administration of DTP vaccine, having occurred after previous administration of DTP vaccine
text