ID

33179

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

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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 3: Solicited Adverse Events (TritanrixTM-HepB or Zilbrix Group)

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Visit
Description

Visit

Data type

text

Groups
Description

Groups

Data type

integer

Solicited Adverse Events
Description

Solicited Adverse Events

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

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

Data type

text

Local Symptoms - Redness
Description

Local Symptoms - Redness

Day
Description

Day

Data type

integer

Redness
Description

Redness

Data type

boolean

If Yes, record the size
Description

If Yes, record the size

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 7?
Description

Ongoing after day 7?

Data type

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Data type

date

Medically attended visit
Description

Medically attended visit

Data type

boolean

If Yes, record the visit type
Description

If Yes, record the visit type

Data type

text

Local Symptoms - Swelling
Description

Local Symptoms - Swelling

Day
Description

Day

Data type

integer

Swelling
Description

Swelling

Data type

boolean

If Yes, record the size
Description

If Yes, record the size

Data type

integer

Measurement units
  • mm
mm
Ongoing after day 7?
Description

Ongoing after day 7?

Data type

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Data type

date

Medically attended visit
Description

Medically attended visit

Data type

boolean

If Yes, record the visit type
Description

If Yes, record the visit type

Data type

text

Local Symptoms - Pain
Description

Local Symptoms - Pain

Day
Description

Day

Data type

integer

Pain
Description

Pain

Data type

boolean

If Yes, record the intensity
Description

If Yes, record the intensity

Data type

text

Ongoing after day 7?
Description

Ongoing after day 7?

Data type

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Data type

date

Medically attended visit
Description

Medically attended visit

Data type

boolean

If Yes, record the visit type
Description

If Yes, record the visit type

Data type

text

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Similar models

Visit 3: Solicited Adverse Events (TritanrixTM-HepB or Zilbrix Group)

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 3 (1)
Item
Groups
integer
Groups
Code List
Groups
CL Item
TritantixTM-HepB (1)
CL Item
Zilbrix (2)
Item Group
Solicited Adverse Events
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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