Contraindications and Elimination Criteria

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Date of Visit
Item
Date of Visit
date
Item Group
Elimination Criteria during the Study
Item
The criteria should be checked at each visit subsequent to the first visit.
text
Code List
The criteria should be checked at each visit subsequent to the first visit.
CL Item
Use of any investigational or non-registered product (drug or vaccine) other that the study vaccine(s) during the study period. (1)
CL Item
Chronic administration (defined as more that 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.) (2)
CL Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before administration of the study vaccine and ending 30 days after, with the exception of OPV. (3)
CL Item
Administration of immunoglobulins and/or any blood products during the study period. (4)
Item Group
Contraindications to Subsequent Vaccination
Item
Contraindications to administration of the study vaccines at that point in time
text
Code List
Contraindications to administration of the study vaccines at that point in time
CL Item
Acute disease at the time of vaccination: the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature <37.5°C / rectal temperature <38°C. (1)
CL Item
Axillary temperature >= 37.5°C / rectal temperature >=38°C at the time of booster vaccination. (2)

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