ID

33182

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

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Versionen (1)
  1. 30.11.18 30.11.18 -
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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

Visit 3: Solicited Adverse Events - General Symptoms

1 Formulare  
Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Visit
Beschreibung

Visit

Datentyp

text

Solicited Adverse Events
Beschreibung

Solicited Adverse Events

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

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

Datentyp

text

Fever
Beschreibung

Fever

Day
Beschreibung

Day

Datentyp

integer

Fever
Beschreibung

Fever

Datentyp

boolean

If Yes, record t°
Beschreibung

If Yes, record t°

Datentyp

float

Maßeinheiten
  • °C
°C
record route
Beschreibung

record route

Datentyp

text

Ongoing after days 7?
Beschreibung

Ongoing after days 7?

Datentyp

boolean

Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

Causality
Beschreibung

Causality

Datentyp

boolean

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

Visit type
Beschreibung

Visit type

Datentyp

text

Irritability/Fussiness
Beschreibung

Irritability/Fussiness

Day
Beschreibung

Day

Datentyp

integer

Irritability/Fussiness
Beschreibung

Irritability/Fussiness

Datentyp

boolean

If Yes, record intensity
Beschreibung

If Yes, record intensity

Datentyp

text

Ongoing after days 7?
Beschreibung

Ongoing after days 7?

Datentyp

boolean

Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

Causality
Beschreibung

Causality

Datentyp

boolean

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

Visit type
Beschreibung

Visit type

Datentyp

text

Drowsiness
Beschreibung

Drowsiness

Day
Beschreibung

Day

Datentyp

integer

Drowsiness
Beschreibung

Drowsiness

Datentyp

boolean

If Yes, record intensity
Beschreibung

If Yes, record intensity

Datentyp

text

Ongoing after days 7?
Beschreibung

Ongoing after days 7?

Datentyp

boolean

Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

Causality
Beschreibung

Causality

Datentyp

boolean

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

Visit type
Beschreibung

Visit type

Datentyp

text

Loss of Appetite
Beschreibung

Loss of Appetite

Day
Beschreibung

Day

Datentyp

integer

Loss of Appetite
Beschreibung

Loss of Appetite

Datentyp

boolean

If Yes, record intensity
Beschreibung

If Yes, record intensity

Datentyp

text

Ongoing after days 7?
Beschreibung

Ongoing after days 7?

Datentyp

boolean

Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

Causality
Beschreibung

Causality

Datentyp

boolean

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

Visit type
Beschreibung

Visit type

Datentyp

text

Vomiting
Beschreibung

Vomiting

Day
Beschreibung

Day

Datentyp

integer

Vomiting
Beschreibung

Vomiting

Datentyp

boolean

If Yes, record number
Beschreibung

If Yes, record number

Datentyp

integer

Ongoing after days 7?
Beschreibung

Ongoing after days 7?

Datentyp

boolean

Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

Causality
Beschreibung

Causality

Datentyp

boolean

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

Diarrhea
Beschreibung

Diarrhea

Day
Beschreibung

Day

Datentyp

integer

Diarrhea
Beschreibung

Diarrhea

Datentyp

boolean

If Yes, record number of looser than normal stools
Beschreibung

If Yes, record number of looser than normal stools

Datentyp

integer

Ongoing after days 7?
Beschreibung

Ongoing after days 7?

Datentyp

boolean

Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

Causality
Beschreibung

Causality

Datentyp

boolean

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

In case of "Severe" Intensity of Crying:
Beschreibung

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)?
Beschreibung

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

Datentyp

boolean

Was the crying unaltered >=3 hours?
Beschreibung

Was the crying unaltered >=3 hours?

Datentyp

boolean

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Ähnliche Modelle

Visit 3: Solicited Adverse Events - General Symptoms

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Visit
text
Visit
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
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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