ID

33180

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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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Versioner (1)
  1. 2018-11-30 2018-11-30 -
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GSK group of companies

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30 november 2018

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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

Engelsk

Visit 3: Solicited Adverse Events (Trople AntigenTM and EngerixTM Group)

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Visit
Beskrivning

Visit

Datatyp

text

Groups
Beskrivning

Groups

Datatyp

integer

Solicited Adverse Events - Triple AntigenTM vaccine
Beskrivning

Solicited Adverse Events - Triple AntigenTM vaccine

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

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

Datatyp

text

Local Symptoms - Redness
Beskrivning

Local Symptoms - Redness

Day
Beskrivning

Day

Datatyp

integer

Redness
Beskrivning

Redness

Datatyp

boolean

If Yes, record the size
Beskrivning

If Yes, record the size

Datatyp

integer

Måttenheter
  • mm
mm
Ongoing after day 7?
Beskrivning

Ongoing after day 7?

Datatyp

boolean

If Yes, record date of last day of symptoms
Beskrivning

If Yes, record date of last day of symptoms

Datatyp

date

Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

If Yes, record the visit type
Beskrivning

If Yes, record the visit type

Datatyp

text

Local Symptoms - Swelling
Beskrivning

Local Symptoms - Swelling

Day
Beskrivning

Day

Datatyp

integer

Swelling
Beskrivning

Swelling

Datatyp

boolean

If Yes, record the size
Beskrivning

If Yes, record the size

Datatyp

integer

Måttenheter
  • mm
mm
Ongoing after day 7?
Beskrivning

Ongoing after day 7?

Datatyp

boolean

If Yes, record date of last day of symptoms
Beskrivning

If Yes, record date of last day of symptoms

Datatyp

date

Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

If Yes, record the visit type
Beskrivning

If Yes, record the visit type

Datatyp

text

Local Symptoms - Pain
Beskrivning

Local Symptoms - Pain

Day
Beskrivning

Day

Datatyp

integer

Pain
Beskrivning

Pain

Datatyp

boolean

If Yes, record the intensity
Beskrivning

If Yes, record the intensity

Datatyp

text

Ongoing after day 7?
Beskrivning

Ongoing after day 7?

Datatyp

boolean

If Yes, record date of last day of symptoms
Beskrivning

If Yes, record date of last day of symptoms

Datatyp

date

Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

If Yes, record the visit type
Beskrivning

If Yes, record the visit type

Datatyp

text

Solicited Adverse Events - EngerixTM-B vaccine
Beskrivning

Solicited Adverse Events - EngerixTM-B vaccine

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

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

Datatyp

text

Local Symptoms - Redness
Beskrivning

Local Symptoms - Redness

Day
Beskrivning

Day

Datatyp

integer

Redness
Beskrivning

Redness

Datatyp

boolean

If Yes, record the size
Beskrivning

If Yes, record the size

Datatyp

integer

Måttenheter
  • mm
mm
Ongoing after day 7?
Beskrivning

Ongoing after day 7?

Datatyp

boolean

If Yes, record date of last day of symptoms
Beskrivning

If Yes, record date of last day of symptoms

Datatyp

date

Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

If Yes, record the visit type
Beskrivning

If Yes, record the visit type

Datatyp

text

Local Symptoms - Swelling
Beskrivning

Local Symptoms - Swelling

Day
Beskrivning

Day

Datatyp

integer

Swelling
Beskrivning

Swelling

Datatyp

boolean

If Yes, record the size
Beskrivning

If Yes, record the size

Datatyp

integer

Måttenheter
  • mm
mm
Ongoing after day 7?
Beskrivning

Ongoing after day 7?

Datatyp

boolean

If Yes, record date of last day of symptoms
Beskrivning

If Yes, record date of last day of symptoms

Datatyp

date

Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

If Yes, record the visit type
Beskrivning

If Yes, record the visit type

Datatyp

text

Local Symptoms - Pain
Beskrivning

Local Symptoms - Pain

Day
Beskrivning

Day

Datatyp

integer

Pain
Beskrivning

Pain

Datatyp

boolean

If Yes, record the intensity
Beskrivning

If Yes, record the intensity

Datatyp

text

Ongoing after day 7?
Beskrivning

Ongoing after day 7?

Datatyp

boolean

If Yes, record date of last day of symptoms
Beskrivning

If Yes, record date of last day of symptoms

Datatyp

date

Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

If Yes, record the visit type
Beskrivning

If Yes, record the visit type

Datatyp

text

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Similar models

Visit 3: Solicited Adverse Events (Trople AntigenTM and EngerixTM Group)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Visit
text
Visit
Code List
Visit
CL Item
Dose 3 (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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