ID

33170

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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  1. 30.11.18 30.11.18 -
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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

Englisch

Visit 2: Solicited Adverse Events (Trople AntigenTM and EngerixTM Group)

1 Formulare  
Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Visit
Beschreibung

Visit

Datentyp

text

Groups
Beschreibung

Groups

Datentyp

integer

Solicited Adverse Events - Triple AntigenTM vaccine
Beschreibung

Solicited Adverse Events - Triple AntigenTM vaccine

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

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

Datentyp

text

Local Symptoms - Redness
Beschreibung

Local Symptoms - Redness

Day
Beschreibung

Day

Datentyp

integer

Redness
Beschreibung

Redness

Datentyp

boolean

If Yes, record the size
Beschreibung

If Yes, record the size

Datentyp

integer

Maßeinheiten
  • mm
mm
Ongoing after day 7?
Beschreibung

Ongoing after day 7?

Datentyp

boolean

If Yes, record date of last day of symptoms
Beschreibung

If Yes, record date of last day of symptoms

Datentyp

date

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

If Yes, record the visit type
Beschreibung

If Yes, record the visit type

Datentyp

text

Local Symptoms - Swelling
Beschreibung

Local Symptoms - Swelling

Day
Beschreibung

Day

Datentyp

integer

Swelling
Beschreibung

Swelling

Datentyp

boolean

If Yes, record the size
Beschreibung

If Yes, record the size

Datentyp

integer

Maßeinheiten
  • mm
mm
Ongoing after day 7?
Beschreibung

Ongoing after day 7?

Datentyp

boolean

If Yes, record date of last day of symptoms
Beschreibung

If Yes, record date of last day of symptoms

Datentyp

date

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

If Yes, record the visit type
Beschreibung

If Yes, record the visit type

Datentyp

text

Local Symptoms - Pain
Beschreibung

Local Symptoms - Pain

Day
Beschreibung

Day

Datentyp

integer

Pain
Beschreibung

Pain

Datentyp

boolean

If Yes, record the intensity
Beschreibung

If Yes, record the intensity

Datentyp

text

Ongoing after day 7?
Beschreibung

Ongoing after day 7?

Datentyp

boolean

If Yes, record date of last day of symptoms
Beschreibung

If Yes, record date of last day of symptoms

Datentyp

date

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

If Yes, record the visit type
Beschreibung

If Yes, record the visit type

Datentyp

text

Solicited Adverse Events - EngerixTM-B vaccine
Beschreibung

Solicited Adverse Events - EngerixTM-B vaccine

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

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

Datentyp

text

Local Symptoms - Redness
Beschreibung

Local Symptoms - Redness

Day
Beschreibung

Day

Datentyp

integer

Redness
Beschreibung

Redness

Datentyp

boolean

If Yes, record the size
Beschreibung

If Yes, record the size

Datentyp

integer

Maßeinheiten
  • mm
mm
Ongoing after day 7?
Beschreibung

Ongoing after day 7?

Datentyp

boolean

If Yes, record date of last day of symptoms
Beschreibung

If Yes, record date of last day of symptoms

Datentyp

date

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

If Yes, record the visit type
Beschreibung

If Yes, record the visit type

Datentyp

text

Local Symptoms - Swelling
Beschreibung

Local Symptoms - Swelling

Day
Beschreibung

Day

Datentyp

integer

Swelling
Beschreibung

Swelling

Datentyp

boolean

If Yes, record the size
Beschreibung

If Yes, record the size

Datentyp

integer

Maßeinheiten
  • mm
mm
Ongoing after day 7?
Beschreibung

Ongoing after day 7?

Datentyp

boolean

If Yes, record date of last day of symptoms
Beschreibung

If Yes, record date of last day of symptoms

Datentyp

date

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

If Yes, record the visit type
Beschreibung

If Yes, record the visit type

Datentyp

text

Local Symptoms - Pain
Beschreibung

Local Symptoms - Pain

Day
Beschreibung

Day

Datentyp

integer

Pain
Beschreibung

Pain

Datentyp

boolean

If Yes, record the intensity
Beschreibung

If Yes, record the intensity

Datentyp

text

Ongoing after day 7?
Beschreibung

Ongoing after day 7?

Datentyp

boolean

If Yes, record date of last day of symptoms
Beschreibung

If Yes, record date of last day of symptoms

Datentyp

date

Medically attended visit
Beschreibung

Medically attended visit

Datentyp

boolean

If Yes, record the visit type
Beschreibung

If Yes, record the visit type

Datentyp

text

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Ähnliche Modelle

Visit 2: Solicited Adverse Events (Trople AntigenTM and EngerixTM Group)

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 2 (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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