ID

33243

Beschrijving

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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Versies (1)
  1. 03-12-18 03-12-18 -
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GSK group of companies

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3 december 2018

DOI

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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

Engels

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

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Dose
Beschrijving

Dose

Datatype

text

Local Symptoms (at injection site) Triple AntigenTM Vaccine
Beschrijving

Local Symptoms (at injection site) Triple AntigenTM Vaccine

Day
Beschrijving

Day

Datatype

text

1. Redness
Beschrijving

size; please measure the greatest diameter

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

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

If yes, record the date of last day of symptoms

Datatype

date

Medically attended visit
Beschrijving

Medically attended visit

Datatype

boolean

2. Swelling
Beschrijving

size; please measure the greatest diameter

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

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

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

Datatype

date

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

3. Pain
Beschrijving

intensity

Datatype

text

Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

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

If Yes, record date of the last day of symptoms

Datatype

date

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

for investigator only
Beschrijving

for investigator only

Side of Injection
Beschrijving

Side of Injection

Datatype

text

Site of Injection
Beschrijving

Site of Injection

Datatype

text

Local Symptoms (at injection site) EngerixTM Vaccine
Beschrijving

Local Symptoms (at injection site) EngerixTM Vaccine

Day
Beschrijving

Day

Datatype

integer

Redness
Beschrijving

size; please measure the greatest diameter

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

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

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

Datatype

date

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

Swelling
Beschrijving

size; please measure the greatest diameter

Datatype

integer

Maateenheden
  • mm
mm
Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

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

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

Datatype

date

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

Pain
Beschrijving

intensity

Datatype

text

Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

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

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

Datatype

text

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

for investigator only
Beschrijving

for investigator only

Side of Injection
Beschrijving

Side of Injection

Datatype

text

Site of Injection
Beschrijving

Site of Injection

Datatype

text

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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Dose
text
Dose
Code List
Dose
CL Item
Dose 3 (1)
Item Group
Local Symptoms (at injection site) Triple AntigenTM Vaccine
Item
Day
text
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)
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
3. Pain
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
Side
Code List
Side of Injection
CL Item
Left (1)
CL Item
Right (2)
Item
Site of Injection
text
Site of Injection
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
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
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
Pain
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
Side of Injection
Code List
Side of Injection
CL Item
Left (1)
CL Item
Right (2)
Item
Site of Injection
text
Site of Injection
Code List
Site of Injection
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
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