ID

33472

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

Trefwoorden

Versies (1)
  1. 10-12-18 10-12-18 -
Houder van rechten

GSK group of companies

Geüploaded op

10 december 2018

DOI

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Licentie

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: Local Symptoms (DTPw-HBV/Hib Kft)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Visit
Beschrijving

Visit

Datatype

text

Protocol Number
Beschrijving

Protocol Number

Datatype

integer

Local Symptoms - Redness (at injection site)
Beschrijving

Local Symptoms - Redness (at injection site)

Day
Beschrijving

Day

Datatype

integer

Size
Beschrijving

please measure the greatest diameter

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after Day 3?
Beschrijving

Ongoing after Day 3?

Datatype

boolean

If Yes, record date of last day of symptoms
Beschrijving

If Yes, record date of last day of symptoms

Datatype

date

Medical attended visit?
Beschrijving

Medical attended visit?

Datatype

boolean

Local Symptoms - Swelling (at injection site)
Beschrijving

Local Symptoms - Swelling (at injection site)

Day
Beschrijving

Day

Datatype

integer

Size
Beschrijving

please measure the greatest diameter

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after Day 3?
Beschrijving

Ongoing after Day 3?

Datatype

boolean

If Yes, record date of last day of symptoms
Beschrijving

If Yes, record date of last day of symptoms

Datatype

date

Medical attended visit?
Beschrijving

Medical attended visit?

Datatype

boolean

Local Symptoms - Pain (at injection site)
Beschrijving

Local Symptoms - Pain (at injection site)

Day
Beschrijving

Day

Datatype

integer

Intensity
Beschrijving

Intensity

Datatype

integer

Ongoing after day 3?
Beschrijving

Ongoing after day 3?

Datatype

boolean

If Yes, record date of last day of symptoms
Beschrijving

If Yes, record date of last day of symptoms

Datatype

date

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

Other Local Symptoms
Beschrijving

Other Local Symptoms

Description
Beschrijving

please specify side(s) and site(s)

Datatype

text

Intensity
Beschrijving

Intensity

Datatype

text

Start date
Beschrijving

Start date

Datatype

date

End date
Beschrijving

End date

Datatype

date

Ongoing?
Beschrijving

Ongoing?

Datatype

boolean

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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