ID

33170

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

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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

Visit 2: Solicited Adverse Events (Trople AntigenTM and EngerixTM Group)

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Visit
Descripción

Visit

Tipo de datos

text

Groups
Descripción

Groups

Tipo de datos

integer

Solicited Adverse Events - Triple AntigenTM vaccine
Descripción

Solicited Adverse Events - Triple AntigenTM vaccine

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Descripción

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

Tipo de datos

text

Local Symptoms - Redness
Descripción

Local Symptoms - Redness

Day
Descripción

Day

Tipo de datos

integer

Redness
Descripción

Redness

Tipo de datos

boolean

If Yes, record the size
Descripción

If Yes, record the size

Tipo de datos

integer

Unidades de medida
  • mm
mm
Ongoing after day 7?
Descripción

Ongoing after day 7?

Tipo de datos

boolean

If Yes, record date of last day of symptoms
Descripción

If Yes, record date of last day of symptoms

Tipo de datos

date

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

Local Symptoms - Swelling
Descripción

Local Symptoms - Swelling

Day
Descripción

Day

Tipo de datos

integer

Swelling
Descripción

Swelling

Tipo de datos

boolean

If Yes, record the size
Descripción

If Yes, record the size

Tipo de datos

integer

Unidades de medida
  • mm
mm
Ongoing after day 7?
Descripción

Ongoing after day 7?

Tipo de datos

boolean

If Yes, record date of last day of symptoms
Descripción

If Yes, record date of last day of symptoms

Tipo de datos

date

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

Local Symptoms - Pain
Descripción

Local Symptoms - Pain

Day
Descripción

Day

Tipo de datos

integer

Pain
Descripción

Pain

Tipo de datos

boolean

If Yes, record the intensity
Descripción

If Yes, record the intensity

Tipo de datos

text

Ongoing after day 7?
Descripción

Ongoing after day 7?

Tipo de datos

boolean

If Yes, record date of last day of symptoms
Descripción

If Yes, record date of last day of symptoms

Tipo de datos

date

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

Solicited Adverse Events - EngerixTM-B vaccine
Descripción

Solicited Adverse Events - EngerixTM-B vaccine

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Descripción

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

Tipo de datos

text

Local Symptoms - Redness
Descripción

Local Symptoms - Redness

Day
Descripción

Day

Tipo de datos

integer

Redness
Descripción

Redness

Tipo de datos

boolean

If Yes, record the size
Descripción

If Yes, record the size

Tipo de datos

integer

Unidades de medida
  • mm
mm
Ongoing after day 7?
Descripción

Ongoing after day 7?

Tipo de datos

boolean

If Yes, record date of last day of symptoms
Descripción

If Yes, record date of last day of symptoms

Tipo de datos

date

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

Local Symptoms - Swelling
Descripción

Local Symptoms - Swelling

Day
Descripción

Day

Tipo de datos

integer

Swelling
Descripción

Swelling

Tipo de datos

boolean

If Yes, record the size
Descripción

If Yes, record the size

Tipo de datos

integer

Unidades de medida
  • mm
mm
Ongoing after day 7?
Descripción

Ongoing after day 7?

Tipo de datos

boolean

If Yes, record date of last day of symptoms
Descripción

If Yes, record date of last day of symptoms

Tipo de datos

date

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

Local Symptoms - Pain
Descripción

Local Symptoms - Pain

Day
Descripción

Day

Tipo de datos

integer

Pain
Descripción

Pain

Tipo de datos

boolean

If Yes, record the intensity
Descripción

If Yes, record the intensity

Tipo de datos

text

Ongoing after day 7?
Descripción

Ongoing after day 7?

Tipo de datos

boolean

If Yes, record date of last day of symptoms
Descripción

If Yes, record date of last day of symptoms

Tipo de datos

date

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

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Similar models

Visit 2: Solicited Adverse Events (Trople AntigenTM and EngerixTM Group)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Visit
text
Visit
Code List
Visit
CL Item
Dose 2 (1)
Item
Groups
integer
Groups
Code List
Groups
CL Item
Triple AntigenTM and EngerixTM Group (1)
Item Group
Solicited Adverse Events - Triple AntigenTM vaccine
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes (please tick No/Yes for each symptom) (4)
Item Group
Local Symptoms - Redness
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
Redness
Item
Redness
boolean
If Yes, record the size
Item
If Yes, record the size
integer
Ongoing after day 7?
Item
Ongoing after day 7?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
Item
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Local Symptoms - Swelling
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
Swelling
Item
Swelling
boolean
If Yes, record the size
Item
If Yes, record the size
integer
Ongoing after day 7?
Item
Ongoing after day 7?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
Item
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Local Symptoms - Pain
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
Pain
Item
Pain
boolean
Item
If Yes, record the intensity
text
If Yes, record the intensity
Code List
If Yes, record the intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 7?
Item
Ongoing after day 7?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
Item
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Solicited Adverse Events - EngerixTM-B vaccine
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes (please tick No/Yes for each symptom) (4)
Item Group
Local Symptoms - Redness
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
Redness
Item
Redness
boolean
If Yes, record the size
Item
If Yes, record the size
integer
Ongoing after day 7?
Item
Ongoing after day 7?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
Item
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Local Symptoms - Swelling
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
Swelling
Item
Swelling
boolean
If Yes, record the size
Item
If Yes, record the size
integer
Ongoing after day 7?
Item
Ongoing after day 7?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
Item
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Local Symptoms - Pain
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
Pain
Item
Pain
boolean
Item
If Yes, record the intensity
text
If Yes, record the intensity
Code List
If Yes, record the intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 7?
Item
Ongoing after day 7?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
Item
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
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