ID

33472

Description

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

Versions (1)
  1. 12/10/18 12/10/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 10, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

English

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

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Visit
Description

Visit

Data type

text

Protocol Number
Description

Protocol Number

Data type

integer

Local Symptoms - Redness (at injection site)
Description

Local Symptoms - Redness (at injection site)

Day
Description

Day

Data type

integer

Size
Description

please measure the greatest diameter

Data type

integer

Measurement units
  • mm
mm
Ongoing after Day 3?
Description

Ongoing after Day 3?

Data type

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Data type

date

Medical attended visit?
Description

Medical attended visit?

Data type

boolean

Local Symptoms - Swelling (at injection site)
Description

Local Symptoms - Swelling (at injection site)

Day
Description

Day

Data type

integer

Size
Description

please measure the greatest diameter

Data type

integer

Measurement units
  • mm
mm
Ongoing after Day 3?
Description

Ongoing after Day 3?

Data type

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Data type

date

Medical attended visit?
Description

Medical attended visit?

Data type

boolean

Local Symptoms - Pain (at injection site)
Description

Local Symptoms - Pain (at injection site)

Day
Description

Day

Data type

integer

Intensity
Description

Intensity

Data type

integer

Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Data type

date

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Other Local Symptoms
Description

Other Local Symptoms

Description
Description

please specify side(s) and site(s)

Data type

text

Intensity
Description

Intensity

Data type

text

Start date
Description

Start date

Data type

date

End date
Description

End date

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Back to the top of the page

Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial