ID

34645

Beschrijving

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

Trefwoorden

Versies (2)
  1. 22-01-19 22-01-19 -
  2. 22-01-19 22-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 januari 2019

DOI

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Licentie

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

Engels

Visit 2 (103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M))) - Check for Study Continuation; Large Swelling Reaction

1 Formulieren  
Check for Study Continuation
Beschrijving

Check for Study Continuation

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

If yes, please complete the next pages.

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Please specify Serious Adverse Event

Datatype

text

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

Please specify Non- serious adverse event

Datatype

text

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

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

Datatype

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
Beschrijving

Please tick who took decision

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0679006
Laboratory Tests
Beschrijving

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Beschrijving

Has a blood sample been taken?

Datatype

boolean

Protocol required concomitant vaccination
Beschrijving

Protocol required concomitant vaccination

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0042196
Has the following protocol required concomitant vaccine been administered? - Japanese encephalitis
Beschrijving

If yes, record date.

Datatype

boolean

Alias
UMLS CUI [1]
C0771080
Date of vaccination - Japanese encephalitis
Beschrijving

Complete only if different from visit date.

Datatype

date

Alias
UMLS CUI [1,1]
C0771080
UMLS CUI [1,2]
C0011008
Has the following protocol required concomitant vaccine been administered? - Varicella
Beschrijving

If yes, record date of vaccination.

Datatype

boolean

Alias
UMLS CUI [1]
C0078048
Date of vaccination - Varicella
Beschrijving

Complete only if different from visit date.

Datatype

date

Alias
UMLS CUI [1,1]
C0078048
UMLS CUI [1,2]
C0011008
Large swelling reaction
Beschrijving

Large swelling reaction

Alias
UMLS CUI-1
C0038999
UMLS CUI-2
C0443286
UMLS CUI-3
C0549177
Vaccine administered for which the large swelling reaction reported:
Beschrijving

Vaccine administered for which the large swelling reaction reported:

Datatype

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0443286
UMLS CUI [1,3]
C0549177
UMLS CUI [2]
C0042210
1. Date of physical examination
Beschrijving

1. Date of physical examination

Datatype

date

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

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

Datatype

boolean

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

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

Datatype

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:
Beschrijving

2.1 Specify how long after vaccination swelling occured

Datatype

integer

Maateenheden
  • hours
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0040223
hours
3. Size of swelling:
Beschrijving

Measurement of the largest diameter

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
4. Type of swelling
Beschrijving

Please specify in section 7.

Datatype

integer

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

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

Datatype

integer

Maateenheden
  • 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):
Beschrijving

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

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C1521805
mm
6a Associated signs - Temperature
Beschrijving

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.

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0037088
UMLS CUI [2]
C0005903
°C
6a. Temperature measurement site
Beschrijving

6a. Temperature measurement site

Datatype

text

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

6b. Redness

Datatype

boolean

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

6b. Largest diameter of Redness

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
mm
6c. Induration
Beschrijving

6c. Induration

Datatype

boolean

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

6c. Induration largest diameter

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C0332534
UMLS CUI [1,2]
C0456389
mm
6d. Pain at administration site
Beschrijving

6d. Pain at administration site

Datatype

boolean

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

6d. Intensity of pain at administration site

Datatype

integer

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

6e. Functional impairment

Datatype

boolean

Alias
UMLS CUI [1]
C4062321
6e. Intensity of Functional Impairment
Beschrijving

6e. Intensity of Functional Impairment

Datatype

integer

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

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
Beschrijving

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.

Datatype

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:
Beschrijving

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

Datatype

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)
Beschrijving

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

Datatype

integer

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

9. Outcome of the large swellling reaction

Datatype

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)
Beschrijving

10. Is there an alternative explanation for the swelling

Datatype

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.
Beschrijving

10.1 Specify alternative explanation for the swelling

Datatype

text

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0681841
UMLS CUI [1,3]
C2348235
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Similar models

Visit 2 (103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M))) - Check for Study Continuation; Large Swelling Reaction

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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
Laboratory Tests
C0022885 (UMLS CUI-1)
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
Item Group
Protocol required concomitant vaccination
C2347852 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Japanese encephalitis
Item
Has the following protocol required concomitant vaccine been administered? - Japanese encephalitis
boolean
C0771080 (UMLS CUI [1])
Date of vaccination - Japanese encephalitis
Item
Date of vaccination - Japanese encephalitis
date
C0771080 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Varicella
Item
Has the following protocol required concomitant vaccine been administered? - Varicella
boolean
C0078048 (UMLS CUI [1])
Date of vaccination - Varicella
Item
Date of vaccination - Varicella
date
C0078048 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Large swelling reaction
C0038999 (UMLS CUI-1)
C0443286 (UMLS CUI-2)
C0549177 (UMLS CUI-3)
Item
Vaccine administered for which the large swelling reaction reported:
integer
C0038999 (UMLS CUI [1,1])
C0443286 (UMLS CUI [1,2])
C0549177 (UMLS CUI [1,3])
C0042210 (UMLS CUI [2])
Vaccine administered for which the large swelling reaction reported:
Code List
Vaccine administered for which the large swelling reaction reported:
CL Item
DTPw-HBV/Hib-MenAC Vaccine (111)
CL Item
DTPw-HBV/Hib Vaccine (94)
CL Item
Meningitec Vaccine (109)
1. Date of physical examination
Item
1. Date of physical examination
date
C2826643 (UMLS CUI [1])
1.1 Was the examination performed by a member of study personnel during the large swelling reaction period:
Item
1.1 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 [2])
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 R=Rectal (Y)
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. Intensity of 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])
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