ID

33472

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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Licens

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: Local Symptoms (DTPw-HBV/Hib Kft)

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Visit
Beskrivning

Visit

Datatyp

text

Protocol Number
Beskrivning

Protocol Number

Datatyp

integer

Local Symptoms - Redness (at injection site)
Beskrivning

Local Symptoms - Redness (at injection site)

Day
Beskrivning

Day

Datatyp

integer

Size
Beskrivning

please measure the greatest diameter

Datatyp

integer

Måttenheter
  • mm
mm
Ongoing after Day 3?
Beskrivning

Ongoing after Day 3?

Datatyp

boolean

If Yes, record date of last day of symptoms
Beskrivning

If Yes, record date of last day of symptoms

Datatyp

date

Medical attended visit?
Beskrivning

Medical attended visit?

Datatyp

boolean

Local Symptoms - Swelling (at injection site)
Beskrivning

Local Symptoms - Swelling (at injection site)

Day
Beskrivning

Day

Datatyp

integer

Size
Beskrivning

please measure the greatest diameter

Datatyp

integer

Måttenheter
  • mm
mm
Ongoing after Day 3?
Beskrivning

Ongoing after Day 3?

Datatyp

boolean

If Yes, record date of last day of symptoms
Beskrivning

If Yes, record date of last day of symptoms

Datatyp

date

Medical attended visit?
Beskrivning

Medical attended visit?

Datatyp

boolean

Local Symptoms - Pain (at injection site)
Beskrivning

Local Symptoms - Pain (at injection site)

Day
Beskrivning

Day

Datatyp

integer

Intensity
Beskrivning

Intensity

Datatyp

integer

Ongoing after day 3?
Beskrivning

Ongoing after day 3?

Datatyp

boolean

If Yes, record date of last day of symptoms
Beskrivning

If Yes, record date of last day of symptoms

Datatyp

date

Medically attended visit?
Beskrivning

Medically attended visit?

Datatyp

boolean

Other Local Symptoms
Beskrivning

Other Local Symptoms

Description
Beskrivning

please specify side(s) and site(s)

Datatyp

text

Intensity
Beskrivning

Intensity

Datatyp

text

Start date
Beskrivning

Start date

Datatyp

date

End date
Beskrivning

End date

Datatyp

date

Ongoing?
Beskrivning

Ongoing?

Datatyp

boolean

Medically attended visit?
Beskrivning

Medically attended visit?

Datatyp

boolean

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Similar models

Diary Card: Local Symptoms (DTPw-HBV/Hib Kft)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Visit
text
Visit
Code List
Visit
CL Item
Vaccination 1 (1)
Protocol Number
Item
Protocol Number
integer
Item Group
Local Symptoms - Redness (at injection site)
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)
Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medical attended visit?
Item
Medical attended visit?
boolean
Item Group
Local Symptoms - Swelling (at injection site)
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)
Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medical attended visit?
Item
Medical attended visit?
boolean
Item Group
Local Symptoms - Pain (at injection site)
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
integer
Intensity
Code List
Intensity
CL Item
Absent (1)
CL Item
Minor reaction to touch (2)
CL Item
Cries/protests on touch (3)
CL Item
Cries when limb is moved/spontaneously painful (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Item Group
Other Local Symptoms
Description
Item
Description
text
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing?
Item
Ongoing?
boolean
Medically attended visit?
Item
Medically attended visit?
boolean
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