ID

33466

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

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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: Non-Serious Adverse Events Form

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Protocol Number
Description

Protocol Number

Data type

integer

Non-Serious Adverse Events
Description

Non-Serious Adverse Events

Has any non-serious adverse event occurred within one month post-vaccination, excluding those recorded on the Solicited AE forms?
Description

Please report all SAE only on the SAE-form.

Data type

boolean

If Yes, please complete the section below
Description

If Yes, please complete the section below

Data type

text

Non-Serious Adverse Events Data
Description

Non-Serious Adverse Events Data

AE Number
Description

AE Number

Data type

integer

Description
Description

Description

Data type

text

Administration sites
Description

Administration sites

Data type

text

Date Started
Description

Date Started

Data type

date

Date Stopped
Description

Date Stopped

Data type

date

Intensity
Description

Intensity

Data type

text

Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Data type

boolean

Outcome
Description

Outcome

Data type

text

Medically attended visit
Description

Medically attended visit

Data type

boolean

If Yes, record the type of visit
Description

If Yes, record the type of visit

Data type

text

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Similar models

Visit 4: Non-Serious Adverse Events Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Item Group
Non-Serious Adverse Events
Has any non-serious adverse event occurred within one month post-vaccination, excluding those recorded on the Solicited AE forms?
Item
Has any non-serious adverse event occurred within one month post-vaccination, excluding those recorded on the Solicited AE forms?
boolean
If Yes, please complete the section below
Item
If Yes, please complete the section below
text
Item Group
Non-Serious Adverse Events Data
Item
AE Number
integer
AE Number
Code List
AE Number
CL Item
Event 1 (1)
CL Item
Event 2 (2)
CL Item
Event 3 (3)
CL Item
Event 4 (4)
Description
Item
Description
text
Item
Administration sites
text
Administration sites
Code List
Administration sites
CL Item
DTPw-HBV/Hib Kft vaccine (1)
CL Item
DTPw-HBV Kft vaccine (2)
CL Item
HiberixTM vaccine (3)
CL Item
Non-administration site (4)
Date Started
Item
Date Started
date
Date Stopped
Item
Date Stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae/resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit
boolean
Item
If Yes, record the type of visit
text
If Yes, record the type of visit
Code List
If Yes, record the type of visit
CL Item
Hospitalisation (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
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