ID

33466

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

Visit 4: Non-Serious Adverse Events Form

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Protocol Number
Beschrijving

Protocol Number

Datatype

integer

Non-Serious Adverse Events
Beschrijving

Non-Serious Adverse Events

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

Please report all SAE only on the SAE-form.

Datatype

boolean

If Yes, please complete the section below
Beschrijving

If Yes, please complete the section below

Datatype

text

Non-Serious Adverse Events Data
Beschrijving

Non-Serious Adverse Events Data

AE Number
Beschrijving

AE Number

Datatype

integer

Description
Beschrijving

Description

Datatype

text

Administration sites
Beschrijving

Administration sites

Datatype

text

Date Started
Beschrijving

Date Started

Datatype

date

Date Stopped
Beschrijving

Date Stopped

Datatype

date

Intensity
Beschrijving

Intensity

Datatype

text

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

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

Datatype

boolean

Outcome
Beschrijving

Outcome

Datatype

text

Medically attended visit
Beschrijving

Medically attended visit

Datatype

boolean

If Yes, record the type of visit
Beschrijving

If Yes, record the type of visit

Datatype

text

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Similar models

Visit 4: Non-Serious Adverse Events Form

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