ID

33171

Description

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

Versions (1)
  1. 11/30/18 11/30/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 30, 2018

DOI

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License

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

English

Visit 2: Solicited Adverse Events - General Symptoms

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Visit
Description

Visit

Data type

text

Solicited Adverse Events
Description

Solicited Adverse Events

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

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

Data type

text

Fever
Description

Fever

Day
Description

Day

Data type

integer

Fever
Description

Fever

Data type

boolean

If Yes, record t°
Description

If Yes, record t°

Data type

float

Measurement units
  • °C
°C
record route
Description

record route

Data type

text

Ongoing after days 7?
Description

Ongoing after days 7?

Data type

boolean

Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Causality
Description

Causality

Data type

boolean

Medically attended visit
Description

Medically attended visit

Data type

boolean

Visit type
Description

Visit type

Data type

text

Irritability/Fussiness
Description

Irritability/Fussiness

Day
Description

Day

Data type

integer

Irritability/Fussiness
Description

Irritability/Fussiness

Data type

boolean

If Yes, record intensity
Description

If Yes, record intensity

Data type

text

Ongoing after days 7?
Description

Ongoing after days 7?

Data type

boolean

Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Causality
Description

Causality

Data type

boolean

Medically attended visit
Description

Medically attended visit

Data type

boolean

Visit type
Description

Visit type

Data type

text

Drowsiness
Description

Drowsiness

Day
Description

Day

Data type

integer

Drowsiness
Description

Drowsiness

Data type

boolean

If Yes, record intensity
Description

If Yes, record intensity

Data type

text

Ongoing after days 7?
Description

Ongoing after days 7?

Data type

boolean

Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Causality
Description

Causality

Data type

boolean

Medically attended visit
Description

Medically attended visit

Data type

boolean

Visit type
Description

Visit type

Data type

text

Loss of Appetite
Description

Loss of Appetite

Day
Description

Day

Data type

integer

Loss of Appetite
Description

Loss of Appetite

Data type

boolean

If Yes, record intensity
Description

If Yes, record intensity

Data type

text

Ongoing after days 7?
Description

Ongoing after days 7?

Data type

boolean

Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Causality
Description

Causality

Data type

boolean

Medically attended visit
Description

Medically attended visit

Data type

boolean

Visit type
Description

Visit type

Data type

text

Vomiting
Description

Vomiting

Day
Description

Day

Data type

integer

Vomiting
Description

Vomiting

Data type

boolean

If Yes, record number
Description

If Yes, record number

Data type

integer

Ongoing after days 7?
Description

Ongoing after days 7?

Data type

boolean

Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Causality
Description

Causality

Data type

boolean

Medically attended visit
Description

Medically attended visit

Data type

text

Diarrhea
Description

Diarrhea

Day
Description

Day

Data type

integer

Diarrhea
Description

Diarrhea

Data type

boolean

If Yes, record number of looser than normal stools
Description

If Yes, record number of looser than normal stools

Data type

integer

Ongoing after days 7?
Description

Ongoing after days 7?

Data type

boolean

Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Causality
Description

Causality

Data type

boolean

Medically attended visit
Description

Medically attended visit

Data type

text

In case of "Severe" Intensity of Crying:
Description

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)?
Description

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

Data type

boolean

Was the crying unaltered >=3 hours?
Description

Was the crying unaltered >=3 hours?

Data type

boolean

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Similar models

Visit 2: Solicited Adverse Events - General Symptoms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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