ID

33243

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

  1. 12/3/18 12/3/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 3, 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

Diary Card 3: Local Symptoms (Triple AntigenTM+EngerixTM-B Group)

Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Dose
Description

Dose

Data type

text

Local Symptoms (at injection site) Triple AntigenTM Vaccine
Description

Local Symptoms (at injection site) Triple AntigenTM Vaccine

Day
Description

Day

Data type

text

1. Redness
Description

size; please measure the greatest diameter

Data type

integer

Measurement units
  • mm
mm
Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

If yes, record the date of last day of symptoms
Description

If yes, record the date of last day of symptoms

Data type

date

Medically attended visit
Description

Medically attended visit

Data type

boolean

2. Swelling
Description

size; please measure the greatest diameter

Data type

integer

Measurement units
  • mm
mm
Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

if Yes, record, day of the last day of symptoms
Description

if Yes, record, day of the last day of symptoms

Data type

date

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

3. Pain
Description

intensity

Data type

text

Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

If Yes, record date of the last day of symptoms
Description

If Yes, record date of the last day of symptoms

Data type

date

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

for investigator only
Description

for investigator only

Side of Injection
Description

Side of Injection

Data type

text

Site of Injection
Description

Site of Injection

Data type

text

Local Symptoms (at injection site) EngerixTM Vaccine
Description

Local Symptoms (at injection site) EngerixTM Vaccine

Day
Description

Day

Data type

integer

Redness
Description

size; please measure the greatest diameter

Data type

integer

Measurement units
  • mm
mm
Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

if Yes, record, day of the last day of symptoms
Description

if Yes, record, day of the last day of symptoms

Data type

date

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Swelling
Description

size; please measure the greatest diameter

Data type

integer

Measurement units
  • mm
mm
Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

if Yes, record, day of the last day of symptoms
Description

if Yes, record, day of the last day of symptoms

Data type

date

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Pain
Description

intensity

Data type

text

Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

if Yes, record, day of the last day of symptoms
Description

if Yes, record, day of the last day of symptoms

Data type

text

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

for investigator only
Description

for investigator only

Side of Injection
Description

Side of Injection

Data type

text

Site of Injection
Description

Site of Injection

Data type

text

Similar models

Diary Card 3: Local Symptoms (Triple AntigenTM+EngerixTM-B Group)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Dose
text
Code List
Dose
CL Item
Dose 3 (1)
Item Group
Local Symptoms (at injection site) Triple AntigenTM Vaccine
Item
Day
text
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)
1. Redness
Item
1. Redness
integer
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
If yes, record the date of last day of symptoms
Item
If yes, record the date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
2. Swelling
Item
2. Swelling
integer
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
if Yes, record, day of the last day of symptoms
Item
if Yes, record, day of the last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Item
3. Pain
text
Code List
3. Pain
CL Item
Absent (1)
CL Item
Minor reaction to touch (2)
CL Item
Cries/protests to touch (3)
CL Item
Cries when limb is moved/spontaneously painful (4)
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
If Yes, record date of the last day of symptoms
Item
If Yes, record date of the last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Item Group
for investigator only
Item
Side of Injection
text
Code List
Side of Injection
CL Item
Left (1)
CL Item
Right (2)
Item
Site of Injection
text
Code List
Site of Injection
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item Group
Local Symptoms (at injection site) EngerixTM Vaccine
Item
Day
integer
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
integer
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
if Yes, record, day of the last day of symptoms
Item
if Yes, record, day of the last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Swelling
Item
Swelling
integer
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
if Yes, record, day of the last day of symptoms
Item
if Yes, record, day of the last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Item
Pain
text
Code List
Pain
CL Item
Absent (1)
CL Item
Minor reaction to touch (2)
CL Item
Cries/protests to touch (3)
CL Item
Cries when limb is moved/spontaneously painful (4)
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
if Yes, record, day of the last day of symptoms
Item
if Yes, record, day of the last day of symptoms
text
Medically attended visit?
Item
Medically attended visit?
boolean
Item Group
for investigator only
Item
Side of Injection
text
Code List
Side of Injection
CL Item
Left (1)
CL Item
Right (2)
Item
Site of Injection
text
Code List
Site of Injection
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)

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