ID

33182

Descrizione

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

Keywords

  1. 30/11/18 30/11/18 -
Titolare del copyright

GSK group of companies

Caricato su

30 novembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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

Visit 3: Solicited Adverse Events - General Symptoms

Administrative data
Descrizione

Administrative data

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Visit
Descrizione

Visit

Tipo di dati

text

Solicited Adverse Events
Descrizione

Solicited Adverse Events

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

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

Tipo di dati

text

Fever
Descrizione

Fever

Day
Descrizione

Day

Tipo di dati

integer

Fever
Descrizione

Fever

Tipo di dati

boolean

If Yes, record t°
Descrizione

If Yes, record t°

Tipo di dati

float

Unità di misura
  • °C
°C
record route
Descrizione

record route

Tipo di dati

text

Ongoing after days 7?
Descrizione

Ongoing after days 7?

Tipo di dati

boolean

Date of last day of symptoms
Descrizione

Date of last day of symptoms

Tipo di dati

date

Causality
Descrizione

Causality

Tipo di dati

boolean

Medically attended visit
Descrizione

Medically attended visit

Tipo di dati

boolean

Visit type
Descrizione

Visit type

Tipo di dati

text

Irritability/Fussiness
Descrizione

Irritability/Fussiness

Day
Descrizione

Day

Tipo di dati

integer

Irritability/Fussiness
Descrizione

Irritability/Fussiness

Tipo di dati

boolean

If Yes, record intensity
Descrizione

If Yes, record intensity

Tipo di dati

text

Ongoing after days 7?
Descrizione

Ongoing after days 7?

Tipo di dati

boolean

Date of last day of symptoms
Descrizione

Date of last day of symptoms

Tipo di dati

date

Causality
Descrizione

Causality

Tipo di dati

boolean

Medically attended visit
Descrizione

Medically attended visit

Tipo di dati

boolean

Visit type
Descrizione

Visit type

Tipo di dati

text

Drowsiness
Descrizione

Drowsiness

Day
Descrizione

Day

Tipo di dati

integer

Drowsiness
Descrizione

Drowsiness

Tipo di dati

boolean

If Yes, record intensity
Descrizione

If Yes, record intensity

Tipo di dati

text

Ongoing after days 7?
Descrizione

Ongoing after days 7?

Tipo di dati

boolean

Date of last day of symptoms
Descrizione

Date of last day of symptoms

Tipo di dati

date

Causality
Descrizione

Causality

Tipo di dati

boolean

Medically attended visit
Descrizione

Medically attended visit

Tipo di dati

boolean

Visit type
Descrizione

Visit type

Tipo di dati

text

Loss of Appetite
Descrizione

Loss of Appetite

Day
Descrizione

Day

Tipo di dati

integer

Loss of Appetite
Descrizione

Loss of Appetite

Tipo di dati

boolean

If Yes, record intensity
Descrizione

If Yes, record intensity

Tipo di dati

text

Ongoing after days 7?
Descrizione

Ongoing after days 7?

Tipo di dati

boolean

Date of last day of symptoms
Descrizione

Date of last day of symptoms

Tipo di dati

date

Causality
Descrizione

Causality

Tipo di dati

boolean

Medically attended visit
Descrizione

Medically attended visit

Tipo di dati

boolean

Visit type
Descrizione

Visit type

Tipo di dati

text

Vomiting
Descrizione

Vomiting

Day
Descrizione

Day

Tipo di dati

integer

Vomiting
Descrizione

Vomiting

Tipo di dati

boolean

If Yes, record number
Descrizione

If Yes, record number

Tipo di dati

integer

Ongoing after days 7?
Descrizione

Ongoing after days 7?

Tipo di dati

boolean

Date of last day of symptoms
Descrizione

Date of last day of symptoms

Tipo di dati

date

Causality
Descrizione

Causality

Tipo di dati

boolean

Medically attended visit
Descrizione

Medically attended visit

Tipo di dati

text

Diarrhea
Descrizione

Diarrhea

Day
Descrizione

Day

Tipo di dati

integer

Diarrhea
Descrizione

Diarrhea

Tipo di dati

boolean

If Yes, record number of looser than normal stools
Descrizione

If Yes, record number of looser than normal stools

Tipo di dati

integer

Ongoing after days 7?
Descrizione

Ongoing after days 7?

Tipo di dati

boolean

Date of last day of symptoms
Descrizione

Date of last day of symptoms

Tipo di dati

date

Causality
Descrizione

Causality

Tipo di dati

boolean

Medically attended visit
Descrizione

Medically attended visit

Tipo di dati

text

In case of "Severe" Intensity of Crying:
Descrizione

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)?
Descrizione

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

Tipo di dati

boolean

Was the crying unaltered >=3 hours?
Descrizione

Was the crying unaltered >=3 hours?

Tipo di dati

boolean

Similar models

Visit 3: Solicited Adverse Events - General Symptoms

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Visit
text
Code List
Visit
CL Item
Dose 3 (1)
Item Group
Solicited Adverse Events
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
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
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
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
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
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
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
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Drowsiness
Item
Day
integer
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
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
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
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
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
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Vomiting
Item
Day
integer
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
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
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
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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