ID

33494

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-12-11 2018-12-11 -
Rättsinnehavare

GSK group of companies

Uppladdad den

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

Engelsk

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

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Protocol Number
Beskrivning

Protocol Number

Datatyp

integer

General Symptoms
Beskrivning

General Symptoms

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

assess the occurrence of general signs or symptoms

Datatyp

text

Temperature
Beskrivning

Temperature

Day
Beskrivning

Day

Datatyp

text

Route
Beskrivning

Route

Datatyp

integer

Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
°C
Ongoing after day 3?
Beskrivning

Ongoing after day 3?

Datatyp

boolean

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

If Yes, record the date of last day of symptoms

Datatyp

date

Was the visit medically attended?
Beskrivning

Medically attended Visit?

Datatyp

boolean

Irritability/Fussiness
Beskrivning

Irritability/Fussiness

Day
Beskrivning

Day

Datatyp

integer

Intensity
Beskrivning

Intensity

Datatyp

text

Ongoing after day 3?
Beskrivning

Ongoing after day 3?

Datatyp

boolean

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

If Yes, record the date of last day of symptoms

Datatyp

date

Was the visit medically attended?
Beskrivning

medically attended visit?

Datatyp

boolean

Was the crying continuous?
Beskrivning

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?

Datatyp

boolean

Was the crying unaltered >=3 hours?
Beskrivning

unaltered crying >= 3 hrs

Datatyp

boolean

Drowsiness
Beskrivning

Drowsiness

Day
Beskrivning

Day

Datatyp

integer

Intensity
Beskrivning

Intensity

Datatyp

text

Ongoing after day 3?
Beskrivning

Ongoing after day 3?

Datatyp

boolean

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

If Yes, record the date of last day of symptoms

Datatyp

date

medically attended visit?
Beskrivning

medically attended visit?

Datatyp

boolean

Loss of Appetite
Beskrivning

Loss of Appetite

Day
Beskrivning

Day

Datatyp

integer

Intensity
Beskrivning

Intensity

Datatyp

text

Ongoing after day 3?
Beskrivning

Ongoing after day 3?

Datatyp

boolean

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

If Yes, record the date of last day of symptoms

Datatyp

date

medically attended visit?
Beskrivning

medically attended visit?

Datatyp

boolean

Other General Symptoms
Beskrivning

Other General Symptoms

Description
Beskrivning

please give details below

Datatyp

integer

Intensity
Beskrivning

Intensity

Datatyp

text

Start date
Beskrivning

Start date

Datatyp

date

End date
Beskrivning

End date

Datatyp

date

Ongoing?
Beskrivning

Ongoing?

Datatyp

boolean

Was the visit medically attended?
Beskrivning

medically attended visit?

Datatyp

boolean

Medications
Beskrivning

Medications

Trade name/Generic name
Beskrivning

Trade name/Generic name

Datatyp

text

Reason
Beskrivning

Reason

Datatyp

text

Total daily dose
Beskrivning

Total daily dose

Datatyp

text

Start date
Beskrivning

Start date

Datatyp

date

End date
Beskrivning

End date

Datatyp

date

Ongoing?
Beskrivning

Ongoing?

Datatyp

boolean

Reminder
Beskrivning

Reminder

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

Record the date below

Datatyp

date

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Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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