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Visit 1: Inclusion Criteria

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Administrative data
Beschrijving

Administrative data

Date of Visit
Beschrijving

Date of Visit

Datatype

date

Subject Number
Beschrijving

Subject Number

Datatype

integer

Eligibility check
Beschrijving

Eligibility check

Did the subject meet all the entry criteria?
Beschrijving

Did the subject meet all the entry criteria?

Datatype

boolean

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

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

Datatype

text

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

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

Datatype

text

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Similar models

Visit 1: Inclusion Criteria

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject 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, 10 to 11 months of age (40-44 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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