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Elimination Criteria (Study Eligibility)

1 Formulär  
Elimination Criteria during the Study
Beskrivning

Elimination Criteria during the Study

Check below "Yes" for all that apply
Beskrivning

The following criteria should be checked at each visit subsequent to the first visit. If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol analysis

Datatyp

text

A. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Beskrivning

A. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.

Datatyp

boolean

B. Chronic administration (more than 14 days) of immunosuppressants or other immunomodifying drugs during the study period.
Beskrivning

For corticosteroids, this mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed

Datatyp

boolean

C. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
Beskrivning

C. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.

Datatyp

boolean

D. Administration of immunoglobulins and/or any blood products during the study period.
Beskrivning

D. Administration of immunoglobulins and/or any blood products during the study period.

Datatyp

boolean

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Elimination Criteria (Study Eligibility)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Elimination Criteria during the Study
Check below "Yes" for all that apply
Item
Check below "Yes" for all that apply
text
A. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Item
A. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
B. Chronic administration (more than 14 days) of immunosuppressants or other immunomodifying drugs during the study period.
Item
B. Chronic administration (more than 14 days) of immunosuppressants or other immunomodifying drugs during the study period.
boolean
C. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
Item
C. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
boolean
D. Administration of immunoglobulins and/or any blood products during the study period.
Item
D. Administration of immunoglobulins and/or any blood products during the study period.
boolean
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