ID

33494

Descrizione

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

Keywords

versioni (1)
  1. 11/12/18 11/12/18 -
Titolare del copyright

GSK group of companies

Caricato su

11 dicembre 2018

DOI

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Licenza

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

Inglese

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

1 moduli  
Administrative data
Descrizione

Administrative data

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Protocol Number
Descrizione

Protocol Number

Tipo di dati

integer

General Symptoms
Descrizione

General Symptoms

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

assess the occurrence of general signs or symptoms

Tipo di dati

text

Temperature
Descrizione

Temperature

Day
Descrizione

Day

Tipo di dati

text

Route
Descrizione

Route

Tipo di dati

integer

Temperature
Descrizione

Temperature

Tipo di dati

float

Unità di misura
  • °C
°C
Ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

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

If Yes, record the date of last day of symptoms

Tipo di dati

date

Was the visit medically attended?
Descrizione

Medically attended Visit?

Tipo di dati

boolean

Irritability/Fussiness
Descrizione

Irritability/Fussiness

Day
Descrizione

Day

Tipo di dati

integer

Intensity
Descrizione

Intensity

Tipo di dati

text

Ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

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

If Yes, record the date of last day of symptoms

Tipo di dati

date

Was the visit medically attended?
Descrizione

medically attended visit?

Tipo di dati

boolean

Was the crying continuous?
Descrizione

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?

Tipo di dati

boolean

Was the crying unaltered >=3 hours?
Descrizione

unaltered crying >= 3 hrs

Tipo di dati

boolean

Drowsiness
Descrizione

Drowsiness

Day
Descrizione

Day

Tipo di dati

integer

Intensity
Descrizione

Intensity

Tipo di dati

text

Ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

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

If Yes, record the date of last day of symptoms

Tipo di dati

date

medically attended visit?
Descrizione

medically attended visit?

Tipo di dati

boolean

Loss of Appetite
Descrizione

Loss of Appetite

Day
Descrizione

Day

Tipo di dati

integer

Intensity
Descrizione

Intensity

Tipo di dati

text

Ongoing after day 3?
Descrizione

Ongoing after day 3?

Tipo di dati

boolean

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

If Yes, record the date of last day of symptoms

Tipo di dati

date

medically attended visit?
Descrizione

medically attended visit?

Tipo di dati

boolean

Other General Symptoms
Descrizione

Other General Symptoms

Description
Descrizione

please give details below

Tipo di dati

integer

Intensity
Descrizione

Intensity

Tipo di dati

text

Start date
Descrizione

Start date

Tipo di dati

date

End date
Descrizione

End date

Tipo di dati

date

Ongoing?
Descrizione

Ongoing?

Tipo di dati

boolean

Was the visit medically attended?
Descrizione

medically attended visit?

Tipo di dati

boolean

Medications
Descrizione

Medications

Trade name/Generic name
Descrizione

Trade name/Generic name

Tipo di dati

text

Reason
Descrizione

Reason

Tipo di dati

text

Total daily dose
Descrizione

Total daily dose

Tipo di dati

text

Start date
Descrizione

Start date

Tipo di dati

date

End date
Descrizione

End date

Tipo di dati

date

Ongoing?
Descrizione

Ongoing?

Tipo di dati

boolean

Reminder
Descrizione

Reminder

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

Record the date below

Tipo di dati

date

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Similar models

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

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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