ID

33171

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

Para solicitar uno, por favor iniciar sesión.

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 - General Symptoms

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Visit
Descripción

Visit

Tipo de datos

text

Solicited Adverse Events
Descripción

Solicited Adverse Events

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

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

Tipo de datos

text

Fever
Descripción

Fever

Day
Descripción

Day

Tipo de datos

integer

Fever
Descripción

Fever

Tipo de datos

boolean

If Yes, record t°
Descripción

If Yes, record t°

Tipo de datos

float

Unidades de medida
  • °C
°C
record route
Descripción

record route

Tipo de datos

text

Ongoing after days 7?
Descripción

Ongoing after days 7?

Tipo de datos

boolean

Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Causality
Descripción

Causality

Tipo de datos

boolean

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

Visit type
Descripción

Visit type

Tipo de datos

text

Irritability/Fussiness
Descripción

Irritability/Fussiness

Day
Descripción

Day

Tipo de datos

integer

Irritability/Fussiness
Descripción

Irritability/Fussiness

Tipo de datos

boolean

If Yes, record intensity
Descripción

If Yes, record intensity

Tipo de datos

text

Ongoing after days 7?
Descripción

Ongoing after days 7?

Tipo de datos

boolean

Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Causality
Descripción

Causality

Tipo de datos

boolean

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

Visit type
Descripción

Visit type

Tipo de datos

text

Drowsiness
Descripción

Drowsiness

Day
Descripción

Day

Tipo de datos

integer

Drowsiness
Descripción

Drowsiness

Tipo de datos

boolean

If Yes, record intensity
Descripción

If Yes, record intensity

Tipo de datos

text

Ongoing after days 7?
Descripción

Ongoing after days 7?

Tipo de datos

boolean

Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Causality
Descripción

Causality

Tipo de datos

boolean

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

Visit type
Descripción

Visit type

Tipo de datos

text

Loss of Appetite
Descripción

Loss of Appetite

Day
Descripción

Day

Tipo de datos

integer

Loss of Appetite
Descripción

Loss of Appetite

Tipo de datos

boolean

If Yes, record intensity
Descripción

If Yes, record intensity

Tipo de datos

text

Ongoing after days 7?
Descripción

Ongoing after days 7?

Tipo de datos

boolean

Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Causality
Descripción

Causality

Tipo de datos

boolean

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

Visit type
Descripción

Visit type

Tipo de datos

text

Vomiting
Descripción

Vomiting

Day
Descripción

Day

Tipo de datos

integer

Vomiting
Descripción

Vomiting

Tipo de datos

boolean

If Yes, record number
Descripción

If Yes, record number

Tipo de datos

integer

Ongoing after days 7?
Descripción

Ongoing after days 7?

Tipo de datos

boolean

Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Causality
Descripción

Causality

Tipo de datos

boolean

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

text

Diarrhea
Descripción

Diarrhea

Day
Descripción

Day

Tipo de datos

integer

Diarrhea
Descripción

Diarrhea

Tipo de datos

boolean

If Yes, record number of looser than normal stools
Descripción

If Yes, record number of looser than normal stools

Tipo de datos

integer

Ongoing after days 7?
Descripción

Ongoing after days 7?

Tipo de datos

boolean

Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Causality
Descripción

Causality

Tipo de datos

boolean

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

text

In case of "Severe" Intensity of Crying:
Descripción

In case of "Severe" Intensity of Crying:

Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
Descripción

Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?

Tipo de datos

boolean

Was the crying unaltered >=3 hours?
Descripción

Was the crying unaltered >=3 hours?

Tipo de datos

boolean

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Similar models

Visit 2: Solicited Adverse Events - General Symptoms

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 Group
Solicited Adverse Events
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Has the subject experienced any of the following signs/symptoms during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (please complete the form below) (4)
Item Group
Fever
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)
Fever
Item
Fever
boolean
If Yes, record t°
Item
If Yes, record t°
float
Item
record route
text
record route
Code List
record route
CL Item
Axillary (1)
CL Item
Rectal (2)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Irritability/Fussiness
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)
Irritability/Fussiness
Item
Irritability/Fussiness
boolean
Item
If Yes, record intensity
text
If Yes, record intensity
Code List
If Yes, record intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Drowsiness
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)
Drowsiness
Item
Drowsiness
boolean
Item
If Yes, record intensity
text
If Yes, record intensity
Code List
If Yes, record intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Loss of Appetite
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)
Loss of Appetite
Item
Loss of Appetite
boolean
Item
If Yes, record intensity
text
If Yes, record intensity
Code List
If Yes, record intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Vomiting
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)
Vomiting
Item
Vomiting
boolean
Item
If Yes, record number
integer
If Yes, record intensity
Code List
If Yes, record number
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Item
Medically attended visit
text
Medically attended visit
Code List
Medically attended visit
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Diarrhea
Day
Item
Day
integer
Diarrhea
Item
Diarrhea
boolean
If Yes, record number of looser than normal stools
Item
If Yes, record number of looser than normal stools
integer
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Item
Medically attended visit
text
Medically attended visit
Code List
Medically attended visit
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
In case of "Severe" Intensity of Crying:
Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
Item
Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
boolean
Was the crying unaltered >=3 hours?
Item
Was the crying unaltered >=3 hours?
boolean
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