ID

33494

Beschrijving

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

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Versies (1)
  1. 11-12-18 11-12-18 -
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GSK group of companies

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11 december 2018

DOI

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Creative Commons BY-NC 3.0
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Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

Engels

Diary card: General Symptoms (DTPw-HBV Kft+HiberixTM)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Protocol Number
Beschrijving

Protocol Number

Datatype

integer

General Symptoms
Beschrijving

General Symptoms

Please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed below.
Beschrijving

assess the occurrence of general signs or symptoms

Datatype

text

Temperature
Beschrijving

Temperature

Day
Beschrijving

Day

Datatype

text

Route
Beschrijving

Route

Datatype

integer

Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • °C
°C
Ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, record the date of last day of symptoms
Beschrijving

If Yes, record the date of last day of symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

Medically attended Visit?

Datatype

boolean

Irritability/Fussiness
Beschrijving

Irritability/Fussiness

Day
Beschrijving

Day

Datatype

integer

Intensity
Beschrijving

Intensity

Datatype

text

Ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, record the date of last day of symptoms
Beschrijving

If Yes, record the date of last day of symptoms

Datatype

date

Was the visit medically attended?
Beschrijving

medically attended visit?

Datatype

boolean

Was the crying continuous?
Beschrijving

In case of crying that connot be comforted and prevents normal activity; i.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps?

Datatype

boolean

Was the crying unaltered >=3 hours?
Beschrijving

unaltered crying >= 3 hrs

Datatype

boolean

Drowsiness
Beschrijving

Drowsiness

Day
Beschrijving

Day

Datatype

integer

Intensity
Beschrijving

Intensity

Datatype

text

Ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, record the date of last day of symptoms
Beschrijving

If Yes, record the date of last day of symptoms

Datatype

date

medically attended visit?
Beschrijving

medically attended visit?

Datatype

boolean

Loss of Appetite
Beschrijving

Loss of Appetite

Day
Beschrijving

Day

Datatype

integer

Intensity
Beschrijving

Intensity

Datatype

text

Ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, record the date of last day of symptoms
Beschrijving

If Yes, record the date of last day of symptoms

Datatype

date

medically attended visit?
Beschrijving

medically attended visit?

Datatype

boolean

Other General Symptoms
Beschrijving

Other General Symptoms

Description
Beschrijving

please give details below

Datatype

integer

Intensity
Beschrijving

Intensity

Datatype

text

Start date
Beschrijving

Start date

Datatype

date

End date
Beschrijving

End date

Datatype

date

Ongoing?
Beschrijving

Ongoing?

Datatype

boolean

Was the visit medically attended?
Beschrijving

medically attended visit?

Datatype

boolean

Medications
Beschrijving

Medications

Trade name/Generic name
Beschrijving

Trade name/Generic name

Datatype

text

Reason
Beschrijving

Reason

Datatype

text

Total daily dose
Beschrijving

Total daily dose

Datatype

text

Start date
Beschrijving

Start date

Datatype

date

End date
Beschrijving

End date

Datatype

date

Ongoing?
Beschrijving

Ongoing?

Datatype

boolean

Reminder
Beschrijving

Reminder

Please do not forget to bring back the diary card on
Beschrijving

Record the date below

Datatype

date

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Similar models

Diary card: General Symptoms (DTPw-HBV Kft+HiberixTM)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Item Group
General Symptoms
assess the occurrence of general signs or symptoms
Item
Please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed below.
text
Item Group
Temperature
Item
Day
text
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Route
integer
Route
Code List
Route
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Tympanic oral (3)
CL Item
Tympanic rectal (4)
CL Item
Rectal (5)
Temperature
Item
Temperature
float
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record the date of last day of symptoms
Item
If Yes, record the date of last day of symptoms
date
Medically attended Visit?
Item
Was the visit medically attended?
boolean
Item Group
Irritability/Fussiness
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 evening (2)
CL Item
Day 2 evening (3)
CL Item
Day 3 evening (4)
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Behaviour as usual (1)
CL Item
Crying more than usual/ no effect on normal activity (2)
CL Item
Crying more than usual/ interferes with normal activity (3)
CL Item
Crying that cannot be comforted/ prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record the date of last day of symptoms
Item
If Yes, record the date of last day of symptoms
date
medically attended visit?
Item
Was the visit medically attended?
boolean
Continuous crying?
Item
Was the crying continuous?
boolean
unaltered crying >= 3 hrs
Item
Was the crying unaltered >=3 hours?
boolean
Item Group
Drowsiness
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 evening (2)
CL Item
Day 2 evening (3)
CL Item
Day 3 evening (4)
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Behavior as usual (1)
CL Item
Drowsiness easily tolerated (2)
CL Item
Drowsiness that interferes with normal activity (3)
CL Item
Drowsiness that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record the date of last day of symptoms
Item
If Yes, record the date of last day of symptoms
date
medically attended visit?
Item
medically attended visit?
boolean
Item Group
Loss of Appetite
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 evening (2)
CL Item
Day 2 evening (3)
CL Item
Day 3 evening (4)
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Appetite as usual (1)
CL Item
Eating less than usual / no effect on normal activity (2)
CL Item
Eating less than usual / interferes with normal activity (3)
CL Item
Not eating at all (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record the date of last day of symptoms
Item
If Yes, record the date of last day of symptoms
date
medically attended visit?
Item
medically attended visit?
boolean
Item Group
Other General Symptoms
Description
Item
Description
integer
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Mild (an AE which is easily tolerated by the subject, causing minimal discomfort and non interfering with everyday activities) (1)
CL Item
Moderate (an AE which is sufficiently discomforting to interfere with normal everyday activities) (2)
CL Item
Severe (an AE which prevents normal, everyday activities: attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice) (3)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing?
Item
Ongoing?
boolean
medically attended visit?
Item
Was the visit medically attended?
boolean
Item Group
Medications
Trade name/Generic name
Item
Trade name/Generic name
text
Reason
Item
Reason
text
Total daily dose
Item
Total daily dose
text
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing?
Item
Ongoing?
boolean
Item Group
Reminder
Please do not forget to bring back the diary card on
Item
Please do not forget to bring back the diary card on
date
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