ID

33191

Beschreibung

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Stichworte

Versionen (1)
  1. 30.11.18 30.11.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

30. November 2018

DOI

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Creative Commons BY-NC 3.0
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Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

Englisch

Non-Serious Adverse Events Form

1 Formulare  
Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

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

Please report all SAE only on the SAE-form.

Datentyp

boolean

If Yes, please complete the section below
Beschreibung

If Yes, please complete the section below

Datentyp

text

Non-Serious Adverse Events Data
Beschreibung

Non-Serious Adverse Events Data

AE Number
Beschreibung

AE Number

Datentyp

integer

Description
Beschreibung

Description

Datentyp

text

Administration sites
Beschreibung

Administration sites

Datentyp

text

Date Started
Beschreibung

Date Started

Datentyp

date

Date Stopped
Beschreibung

Date Stopped

Datentyp

date

Intensity
Beschreibung

Intensity

Datentyp

text

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

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

Datentyp

boolean

Outcome
Beschreibung

Outcome

Datentyp

text

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

If Yes, record the type of visit
Beschreibung

If Yes, record the type of visit

Datentyp

text

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Ähnliche Modelle

Non-Serious Adverse Events Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject 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
TritanrixTM-HepB vaccine (1)
CL Item
ZilbrixTM vaccine (2)
CL Item
Triple AntigenTM vaccine (3)
CL Item
EngerixTM-B vaccine (4)
CL Item
Non-administration site (5)
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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