ID

34644

Description

Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Patient Level Data:N/A Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Keywords

Versions (4)
  1. 1/16/19 1/16/19 -
  2. 1/18/19 1/18/19 -
  3. 1/22/19 1/22/19 -
  4. 1/22/19 1/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 22, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727

English

Visit 2 (104727 ( DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months) )) - Study Continuation; Date of Birth; Large swelling reaction; Concomitant vaccination

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation
Description

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for visit 2?
Description

If yes, please complete the next pages.

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
If subject did not return for visit 2, please tick the ONE most appropriate reason and skip the following pages of this visit.
Description

If subject did not return for visit 2, please tick the ONE most appropriate reason

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
UMLS CUI [2]
C0392360
Please specify Serious Adverse Event
Description

Please specify Serious Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348235
Please specify Non- serious adverse event
Description

Please specify Non- serious adverse event

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C1518404
Specify other reason for subject didn't return for visit 2
Description

Specify other reason for subject didn't return for visit 2

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0392360
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Please tick who took descision
Description

Please tick who took decision

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0679006
Date of Birth
Description

Date of Birth

Alias
UMLS CUI-1
C0421451
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Large swelling reaction - Report of physical examination
Description

Large swelling reaction - Report of physical examination

Alias
UMLS CUI-1
C0038999
UMLS CUI-2
C0443286
UMLS CUI-3
C0549177
UMLS CUI-4
C0031809
1. Date of physical examination
Description

1. Date of physical examination

Data type

date

Alias
UMLS CUI [1]
C2826643
Was the examination performed by a member of study personnel during the large swelling reaction period?
Description

Was the examination performed by a member of study personnel during the large swelling reaction period?

Data type

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0038999
2. Date when the swelling was first considered to be a large swelling reaction:
Description

2. Date when the swelling was first considered to be a large swelling reaction

Data type

date

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0549177
UMLS CUI [1,3]
C0011008
2.1 If swelling occuring within 24 hours after vaccination, please specify how long after vaccination:
Description

2.1 Specify how long after vaccination swelling occured

Data type

integer

Measurement units
  • hours
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0040223
hours
3. Size of swelling:
Description

Measurement of the largest diameter

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
4. Type of swelling
Description

Please specify in section 7.

Data type

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0332307
5a. Circumference of swollen limb (at the site of maximum swelling):
Description

5a. Circumference of swollen limb (at the site of maximum swelling):

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C0038999
mm
5b. Circumference of the opposite limb (at the same level):
Description

5b. Circumference of the opposite limb (at the same level):

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C1521805
mm
6a. Associated signs - Temperature
Description

Please record the temperature. If temperature has been taken more than once a day please report the highest value. Please check a Yes/ No box for each symptom occuring during the large swelling reaction period. If other symptoms are associated with the large swelling reaction. Please specify under section 7.

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0037088
UMLS CUI [2]
C0005903
°C
6a. Temperature measurement site
Description

6a. Temperature measurement site

Data type

text

Alias
UMLS CUI [1]
C0489453
6b. Redness
Description

6b. Redness

Data type

boolean

Alias
UMLS CUI [1]
C0332575
6b. Largest diameter of Redness
Description

6b. Largest diameter of Redness

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
mm
6c. Induration
Description

6c. Induration

Data type

boolean

Alias
UMLS CUI [1]
C0332534
6c. Largest diameter of induration
Description

6c. Induration largest diameter

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332534
UMLS CUI [1,2]
C0456389
mm
6d. Pain at administration site
Description

6d. Pain at administration site

Data type

boolean

Alias
UMLS CUI [1]
C0521491
6d. Intensity of pain at administration site
Description

6d. Intensity of pain at administration site

Data type

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
6e. Functional impairment
Description

6e. Functional impairment

Data type

boolean

Alias
UMLS CUI [1]
C4062321
6e. Intensity of Functional impairment
Description

6e. Intensity of Functional impairment

Data type

integer

Alias
UMLS CUI [1,1]
C4062321
UMLS CUI [1,2]
C0518690
Large swelling reaction - Clinical case desciption and outcome of the adverse event
Description

Large swelling reaction - Clinical case desciption and outcome of the adverse event

Alias
UMLS CUI-1
C0038999
UMLS CUI-2
C0443286
UMLS CUI-3
C0549177
UMLS CUI-4
C0678257
UMLS CUI-5
C0205210
UMLS CUI-6
C1705586
7. Case description
Description

Please give a clinical description of the observed large swelling reaction, including a description of the joint involved and specific associated symptoms. Please mention also eventual dignostic(s) procedures and therapeutic interventions.

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C0868928
8. Last date when the swelling was still considered to be a large swelling reaction:
Description

8. Last date when the swelling was still considered to be a large swelling reaction

Data type

date

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0549177
UMLS CUI [1,3]
C0806020
8.1 If swelling lasting for less than 24 hours, please specify duration (hours)
Description

8.1 If swelling lasting for less than 24 hours, please specify duration

Data type

integer

Measurement units
  • hours
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0449238
hours
9. Outcome of the large swellling reaction:
Description

9. Outcome of the large swellling reaction

Data type

integer

Alias
UMLS CUI [1,1]
C0085565
UMLS CUI [1,2]
C0038999
10. Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
Description

10. Is there an alternative explanation for the swelling

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0681841
UMLS CUI [2]
C0020517
UMLS CUI [3]
C0009450
UMLS CUI [4]
C3714660
UMLS CUI [5]
C0009488
10.1 Specify alternative explanation for the swelling.
Description

10.1 Specify alternative explanation for the swelling

Data type

text

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0681841
UMLS CUI [1,3]
C2348235
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Description

undefined item

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2368628
UMLS CUI [2,1]
C2368628
UMLS CUI [2,2]
C0205394
Concomitant Vaccination specification
Description

Concomitant Vaccination specification

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
UMLS CUI-3
C2348235
Trade / (Generic) Name
Description

Trade / (Generic) Name

Data type

text

Alias
UMLS CUI [1]
C2360065
UMLS CUI [2]
C0592502
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Administration date
Description

Administration date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
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Similar models

Visit 2 (104727 ( DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months) )) - Study Continuation; Date of Birth; Large swelling reaction; Concomitant vaccination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Did the subject return for visit 2?
Item
Did the subject return for visit 2?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
If subject did not return for visit 2, please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0392360 (UMLS CUI [2])
If subject did not return for visit 2, please tick the ONE most appropriate reason
Code List
If subject did not return for visit 2, please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non- Serious adverse event (complete the Non- serious Adverse Event form) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, Protocol violation,...) (OTH)
Please specify Serious Adverse Event
Item
Please specify Serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Please specify Non- serious adverse event
Item
Please specify Non- serious adverse event
text
C2348235 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Specify other reason for subject didn't return for visit 2
Item
Specify other reason for subject didn't return for visit 2
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Please tick who took descision
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,4])
Please tick who took decision
Code List
Please tick who took descision
CL Item
Investigator (I)
CL Item
Parents/ Guardians (P)
Item Group
Date of Birth
C0421451 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item Group
Large swelling reaction - Report of physical examination
C0038999 (UMLS CUI-1)
C0443286 (UMLS CUI-2)
C0549177 (UMLS CUI-3)
C0031809 (UMLS CUI-4)
1. Date of physical examination
Item
1. Date of physical examination
date
C2826643 (UMLS CUI [1])
Was the examination performed by a member of study personnel during the large swelling reaction period?
Item
Was the examination performed by a member of study personnel during the large swelling reaction period?
boolean
C0035173 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
2. Date when the swelling was first considered to be a large swelling reaction
Item
2. Date when the swelling was first considered to be a large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
2.1 Specify how long after vaccination swelling occured
Item
2.1 If swelling occuring within 24 hours after vaccination, please specify how long after vaccination:
integer
C0038999 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
3. Size of swelling
Item
3. Size of swelling:
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
4. Type of swelling
integer
C0038999 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
4. Type of swelling
Code List
4. Type of swelling
CL Item
Local swelling around injection site, not involving adjacent joint (1)
CL Item
Diffuse swelling, not involving adjacent joint (2)
CL Item
Swelling, involving adjacent joint (3)
5a. Circumference of swollen limb (at the site of maximum swelling):
Item
5a. Circumference of swollen limb (at the site of maximum swelling):
integer
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
5b. Circumference of the opposite limb (at the same level):
Item
5b. Circumference of the opposite limb (at the same level):
integer
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1521805 (UMLS CUI [1,3])
6a. Associated signs
Item
6a. Associated signs - Temperature
float
C0037088 (UMLS CUI [1])
C0005903 (UMLS CUI [2])
Item
6a. Temperature measurement site
text
C0489453 (UMLS CUI [1])
6a. Temperature measurement site
Code List
6a. Temperature measurement site
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Typanic oral (X)
CL Item
Tympanic rectal (Y)
CL Item
Rectal (R)
6b. Redness
Item
6b. Redness
boolean
C0332575 (UMLS CUI [1])
6b. Largest diameter of Redness
Item
6b. Largest diameter of Redness
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
6c. Induration
Item
6c. Induration
boolean
C0332534 (UMLS CUI [1])
6c. Induration largest diameter
Item
6c. Largest diameter of induration
integer
C0332534 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
6d. Pain at administration site
Item
6d. Pain at administration site
boolean
C0521491 (UMLS CUI [1])
Item
6d. Intensity of pain at administration site
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
6d. Intensity of pain at administration site
Code List
6d. Intensity of pain at administration site
CL Item
Grade 1 (Minor reaction to touch) (1)
CL Item
Cries / protests on touch (2)
CL Item
Cries when limbs is moved / spontaneously painful (3)
6e. Functional impairment
Item
6e. Functional impairment
boolean
C4062321 (UMLS CUI [1])
Item
6e. Intensity of Functional impairment
integer
C4062321 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
6e. Functional impairment
Code List
6e. Intensity of Functional impairment
CL Item
Grade 1 (Easily tolerated, causing minimal discomfort and not interfering with everyday activities) (1)
CL Item
Grade 2 (Sufficiently discomforting to interfere with normal everyday activities) (2)
CL Item
Grade 3 (Prevents normal everyday activities) (3)
Item Group
Large swelling reaction - Clinical case desciption and outcome of the adverse event
C0038999 (UMLS CUI-1)
C0443286 (UMLS CUI-2)
C0549177 (UMLS CUI-3)
C0678257 (UMLS CUI-4)
C0205210 (UMLS CUI-5)
C1705586 (UMLS CUI-6)
7. Case description
Item
7. Case description
text
C0678257 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0868928 (UMLS CUI [1,3])
8. Last date when the swelling was still considered to be a large swelling reaction
Item
8. Last date when the swelling was still considered to be a large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C0549177 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
8.1 If swelling lasting for less than 24 hours, please specify duration
Item
8.1 If swelling lasting for less than 24 hours, please specify duration (hours)
integer
C0038999 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
9. Outcome of the large swellling reaction:
integer
C0085565 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
9. Outcome of the large swellling reaction
Code List
9. Outcome of the large swellling reaction:
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered/ not resolved (please provide further follow- up data) (3)
CL Item
Recovered with sequelae / resolved with sequelae (please specify under section 7) (4)
10. Is there an alternative explanation for the swelling
Item
10. Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
boolean
C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
C0009488 (UMLS CUI [5])
10.1 Specify alternative explanation for the swelling
Item
10.1 Specify alternative explanation for the swelling.
text
C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
undefined item
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
C0304229 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Item Group
Concomitant Vaccination specification
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2348235 (UMLS CUI-3)
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
C2360065 (UMLS CUI [1])
C0592502 (UMLS CUI [2])
Item
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
Administration date
Item
Administration date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
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