ID

33462

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. 2018-12-10 2018-12-10 -
Rättsinnehavare

GSK group of companies

Uppladdad den

10 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

Visit 4: Solicited Adverse Events - General Symptoms

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Protocol Number
Beskrivning

Protocol Number

Datatyp

integer

Solicited Adverse Events
Beskrivning

Solicited Adverse Events

Has the subject experienced any of the following signs/symptoms during the solicited period?
Beskrivning

Has the subject experienced any of the following signs/symptoms during the solicited period?

Datatyp

text

Fever
Beskrivning

Fever

Day
Beskrivning

Day

Datatyp

integer

Fever
Beskrivning

Fever

Datatyp

boolean

If Yes, record t°
Beskrivning

If Yes, record t°

Datatyp

float

Måttenheter
  • °C
°C
record route
Beskrivning

record route

Datatyp

text

Ongoing after days 7?
Beskrivning

Ongoing after days 7?

Datatyp

boolean

Date of last day of symptoms
Beskrivning

Date of last day of symptoms

Datatyp

date

Causality
Beskrivning

Causality

Datatyp

boolean

Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Visit type
Beskrivning

Visit type

Datatyp

text

Irritability/Fussiness
Beskrivning

Irritability/Fussiness

Day
Beskrivning

Day

Datatyp

integer

Irritability/Fussiness
Beskrivning

Irritability/Fussiness

Datatyp

boolean

If Yes, record intensity
Beskrivning

If Yes, record intensity

Datatyp

text

Ongoing after days 7?
Beskrivning

Ongoing after days 7?

Datatyp

boolean

Date of last day of symptoms
Beskrivning

Date of last day of symptoms

Datatyp

date

Causality
Beskrivning

Causality

Datatyp

boolean

Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Visit type
Beskrivning

Visit type

Datatyp

text

Drowsiness
Beskrivning

Drowsiness

Day
Beskrivning

Day

Datatyp

integer

Drowsiness
Beskrivning

Drowsiness

Datatyp

boolean

If Yes, record intensity
Beskrivning

If Yes, record intensity

Datatyp

text

Ongoing after days 7?
Beskrivning

Ongoing after days 7?

Datatyp

boolean

Date of last day of symptoms
Beskrivning

Date of last day of symptoms

Datatyp

date

Causality
Beskrivning

Causality

Datatyp

boolean

Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Visit type
Beskrivning

Visit type

Datatyp

text

Loss of Appetite
Beskrivning

Loss of Appetite

Day
Beskrivning

Day

Datatyp

integer

Loss of Appetite
Beskrivning

Loss of Appetite

Datatyp

boolean

If Yes, record intensity
Beskrivning

If Yes, record intensity

Datatyp

text

Ongoing after days 7?
Beskrivning

Ongoing after days 7?

Datatyp

boolean

Date of last day of symptoms
Beskrivning

Date of last day of symptoms

Datatyp

date

Causality
Beskrivning

Causality

Datatyp

boolean

Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Visit type
Beskrivning

Visit type

Datatyp

text

In case of "Severe" Intensity of Crying:
Beskrivning

In case of "Severe" Intensity of Crying:

Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
Beskrivning

Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?

Datatyp

boolean

Was the crying unaltered >=3 hours?
Beskrivning

Was the crying unaltered >=3 hours?

Datatyp

boolean

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Similar models

Visit 4: Solicited Adverse Events - General Symptoms

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Date of Visit
Item
Date of Visit
date
Protocol Number
Item
Protocol Number
integer
Item Group
Solicited Adverse Events
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Has the subject experienced any of the following signs/symptoms during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (please complete the form below) (4)
Item Group
Fever
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
Fever
Item
Fever
boolean
If Yes, record t°
Item
If Yes, record t°
float
Item
record route
text
record route
Code List
record route
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Tympanic oral (3)
CL Item
Tympanic rectal (4)
CL Item
Rectal (5)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Irritability/Fussiness
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
Irritability/Fussiness
Item
Irritability/Fussiness
boolean
Item
If Yes, record intensity
text
If Yes, record intensity
Code List
If Yes, record intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Drowsiness
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
Drowsiness
Item
Drowsiness
boolean
Item
If Yes, record intensity
text
If Yes, record intensity
Code List
If Yes, record intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Loss of Appetite
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
Loss of Appetite
Item
Loss of Appetite
boolean
Item
If Yes, record intensity
text
If Yes, record intensity
Code List
If Yes, record intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
In case of "Severe" Intensity of Crying:
Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
Item
Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
boolean
Was the crying unaltered >=3 hours?
Item
Was the crying unaltered >=3 hours?
boolean
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