ID

33191

Descripción

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

Palabras clave

Versiones (1)
  1. 30/11/18 30/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

30 de noviembre de 2018

DOI

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Licencia

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

Inglés

Non-Serious Adverse Events Form

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Non-Serious Adverse Events
Descripción

Non-Serious Adverse Events

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

Please report all SAE only on the SAE-form.

Tipo de datos

boolean

If Yes, please complete the section below
Descripción

If Yes, please complete the section below

Tipo de datos

text

Non-Serious Adverse Events Data
Descripción

Non-Serious Adverse Events Data

AE Number
Descripción

AE Number

Tipo de datos

integer

Description
Descripción

Description

Tipo de datos

text

Administration sites
Descripción

Administration sites

Tipo de datos

text

Date Started
Descripción

Date Started

Tipo de datos

date

Date Stopped
Descripción

Date Stopped

Tipo de datos

date

Intensity
Descripción

Intensity

Tipo de datos

text

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

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

Tipo de datos

boolean

Outcome
Descripción

Outcome

Tipo de datos

text

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

If Yes, record the type of visit
Descripción

If Yes, record the type of visit

Tipo de datos

text

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Similar models

Non-Serious Adverse Events Form

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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