ID

43869

Beskrivning

This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553. The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™. The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine. NCT00370396 Part: Diary Card: General Symptoms

Nyckelord

Versioner (3)
  1. 2016-05-10 2016-05-10 -
  2. 2016-05-11 2016-05-11 -
  3. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0
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Diary Card: General Symptoms Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

Engelsk

Diary Card: General Symptoms "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulär  
Identification
Beskrivning

Identification

Alias
UMLS CUI-1
C1300638
Center number
Beskrivning

Center number

Datatyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0805701
Subject ID
Beskrivning

Subject ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Beskrivning

Treatment Number

Datatyp

text

Alias
UMLS CUI [1]
C1522541
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beskrivning

Gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Date of vaccination
Beskrivning

Vaccination Date

Datatyp

date

Alias
UMLS CUI [1]
C1115436
General Symptoms
Beskrivning

General Symptoms

Alias
UMLS CUI-1
C1457887
Symptom
Beskrivning

Please fill in below and assess the occurrence of any of the followinq siqns or symptoms accordinq to the criteria listed hereafter: Temperature: Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value for the day. Intensity: Irritability / fussiness: 0: Behavior as usual Drowsiness: Loss of appetite: 0: Behavior as usual 0: Appetite as usual 1: Crying more than usual I no effect on normal activity 2: Crying more than usual I interferes with normal activity 3: Crying that cannot be comforted I prevents normal 1: Drowsiness easily tolerated 2: Drowsiness that interferes with normal activity 3:Drowsiness that prevents normal activity 1: Eating less than usual I no effect on normal activity activity 2: Eating less than usual I interferes with normal activity 3: Not eating at all Other general svmptoms: 1:Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2:Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3:Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kinderqarten/a day-care center and would cause the parents/guardians to seek medical advice).

Datatyp

integer

Alias
UMLS CUI [1]
C1457887
Temperature / Intensity
Beskrivning

Temperature / Intensity Day 0

Datatyp

text

Alias
UMLS CUI [1]
C0518690
UMLS CUI [2]
C0039476
Temperature Measurement site
Beskrivning

Temperature Measurement site

Datatyp

integer

Alias
UMLS CUI [1]
C1515974
Temperature / Intensity Day 1
Beskrivning

Temperature / Intensity Day 1

Datatyp

text

Alias
UMLS CUI [1]
C0518690
UMLS CUI [2]
C0039476
Temperature / Intensity Day 2
Beskrivning

Temperature / Intensity Day 2

Datatyp

text

Alias
UMLS CUI [1]
C0518690
UMLS CUI [2]
C0039476
Temperature / Intensity Day 3
Beskrivning

Temperature / Intensity Day 3

Datatyp

text

Alias
UMLS CUI [1]
C0518690
UMLS CUI [2]
C0039476
Ongoing after Day 3
Beskrivning

Ongoing after Day 3

Datatyp

boolean

Alias
UMLS CUI [1]
C0449238
Date of last Symptoms
Beskrivning

Date of last Symptoms

Datatyp

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0011008
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1]
C0545082
Other General Symptoms
Beskrivning

Other General Symptoms

Alias
UMLS CUI-1
C1457887
Description
Beskrivning

Description

Datatyp

text

Alias
UMLS CUI [1]
C0678257
Intensity
Beskrivning

Intensity

Datatyp

integer

Alias
UMLS CUI [1]
C0522510
Start date:
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
End date
Beskrivning

End date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

Alias
UMLS CUI [1]
C0545082
Medication
Beskrivning

Medication

Alias
UMLS CUI-1
C0013227
Trade/Generic name
Beskrivning

Name

Datatyp

text

Alias
UMLS CUI [1]
C0027365
Reason
Beskrivning

Reason

Datatyp

text

Alias
UMLS CUI [1]
C0392360
total daily dose
Beskrivning

total daily dose

Datatyp

text

Måttenheter
  • mg
Alias
UMLS CUI [1]
C2348070
mg
Start date
Beskrivning

Start date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date
Beskrivning

End date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Continuing
Beskrivning

Continuing

Datatyp

boolean

Alias
UMLS CUI [1]
C0549178
Administration
Beskrivning

Administration

Please Do Not Forget To Bring Back The Diary Card On
Beskrivning

Return Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0489552
UMLS CUI [1,2]
C0011008
In Case Of Hospitalisation, Please Inform
Beskrivning

Telephone number

Datatyp

integer

Alias
UMLS CUI [1]
C1515258
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Similar models

Diary Card: General Symptoms "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Identification
C1300638 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (m)
CL Item
Female (f)
Vaccination Date
Item
Date of vaccination
date
C1115436 (UMLS CUI [1])
Item Group
General Symptoms
C1457887 (UMLS CUI-1)
Item
Symptom
integer
C1457887 (UMLS CUI [1])
Symptom
Code List
Symptom
CL Item
Temperature (1)
CL Item
Irritability/Fussiness (2)
CL Item
Drowsiness (3)
CL Item
Loss of Appetite (4)
Temperature / Intensity Day 0
Item
Temperature / Intensity
text
C0518690 (UMLS CUI [1])
C0039476 (UMLS CUI [2])
Item
Temperature Measurement site
integer
C1515974 (UMLS CUI [1])
Temperature Measurement site
Code List
Temperature Measurement site
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Tymp (oral setting) (3)
CL Item
Tymp (rectal setting) (4)
CL Item
Rectal (preferably) (5)
Item
Temperature / Intensity Day 1
text
C0518690 (UMLS CUI [1])
C0039476 (UMLS CUI [2])
Temperature / Intensity Day 1
Code List
Temperature / Intensity Day 1
Temperature / Intensity Day 2
Item
Temperature / Intensity Day 2
text
C0518690 (UMLS CUI [1])
C0039476 (UMLS CUI [2])
Temperature / Intensity Day 3
Item
Temperature / Intensity Day 3
text
C0518690 (UMLS CUI [1])
C0039476 (UMLS CUI [2])
Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0449238 (UMLS CUI [1])
Date of last Symptoms
Item
Date of last Symptoms
date
C1457887 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1])
Item Group
Other General Symptoms
C1457887 (UMLS CUI-1)
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Intensity
Item
Intensity
integer
C0522510 (UMLS CUI [1])
Start Date
Item
Start date:
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1])
Item Group
Medication
C0013227 (UMLS CUI-1)
Name
Item
Trade/Generic name
text
C0027365 (UMLS CUI [1])
Reason
Item
Reason
text
C0392360 (UMLS CUI [1])
total daily dose
Item
total daily dose
text
C2348070 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Continuing
Item
Continuing
boolean
C0549178 (UMLS CUI [1])
Item Group
Administration
Return Date
Item
Please Do Not Forget To Bring Back The Diary Card On
date
C0489552 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Telephone number
Item
In Case Of Hospitalisation, Please Inform
integer
C1515258 (UMLS CUI [1])
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