ID

33463

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

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License

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

English

Visit 4: Concomitant Medications

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Date of Visit
Description

Visit Date

Data type

date

Have any medications/treatments been administered during study period?
Description

Have any medications/treatments been administered during study period?

Data type

boolean

Medication
Description

Medication

Trade Name/Generic Name
Description

Trade Name/Generic Name

Data type

text

Total Daily Dose
Description

Total Daily Dose

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

Medical Indication
Description

Medical Indication

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Route
Description

Route

Data type

text

Reminder
Description

Reminder

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

fill the date below

Data type

date

In case of hospitalisation, please inform
Description

fill the name below

Data type

text

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Visit 4: Concomitant Medications

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Visit Date
Item
Date of Visit
date
Have any medications/treatments been administered during study period?
Item
Have any medications/treatments been administered during study period?
boolean
Item Group
Medication
Trade Name/Generic Name
Item
Trade Name/Generic Name
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
Medical Indication
text
Medical Indication
Code List
Medical Indication
CL Item
Prophylactic (1)
CL Item
Other (2)
If Other, specify
Item
If Other, specify
text
Item
Route
text
Route
Code List
Route
CL Item
External (1)
CL Item
Intradermal (2)
CL Item
Inhalation (3)
CL Item
Intramuscular (4)
CL Item
Intraarticular (5)
CL Item
Intrathecal (6)
CL Item
Intravenous (7)
CL Item
Intranasal (8)
CL Item
Other (9)
CL Item
Parenteral (10)
CL Item
Oral (11)
CL Item
Rectal (12)
CL Item
Subcutaneous (13)
CL Item
Sublingual (14)
CL Item
Transdermal (15)
CL Item
Topical (16)
CL Item
Unknown (17)
CL Item
Vaginal (18)
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
In case of hospitalisation, please inform
Item
In case of hospitalisation, please inform
text
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