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Visit 3: Inclusion Criteria

1 Formulär  
Administrative data
Beskrivning

Administrative data

Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Protocol Number
Beskrivning

Protocol Number

Datatyp

integer

Eligibility check
Beskrivning

Eligibility check

Did the subject meet all the entry criteria?
Beskrivning

Did the subject meet all the entry criteria?

Datatyp

boolean

If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
Beskrivning

Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria listed below

Datatyp

text

Inclusion Criteria
Beskrivning

Inclusion Criteria

For subjects receiving Plain PRP followed by DTPw-HBV Kft:
Beskrivning

For subjects receiving Plain PRP followed by DTPw-HBV Kft:

Datatyp

text

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Similar models

Visit 3: Inclusion Criteria

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Item Group
Eligibility check
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
Item
If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
text
Item Group
Inclusion Criteria
Item
For subjects receiving Plain PRP followed by DTPw-HBV Kft:
text
For subjects receiving Plain PRP followed by DTPw-HBV Kft:
Code List
For subjects receiving Plain PRP followed by DTPw-HBV Kft:
CL Item
A male or female infant, 15 to 18 months of age (60-72 weeks), who completed the primary vaccination course in the study DTPw-HBV=Hib Kft-001 (1)
CL Item
Subject who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study (2)
CL Item
Written informed consent obtained from the parent or guardian of the subject (3)
CL Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study (4)
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