ID

14997

Beschrijving

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: Local Symptoms

Trefwoorden

Versies (2)
  1. 10-05-16 10-05-16 -
  2. 11-05-16 11-05-16 -
Geüploaded op

11 mei 2016

DOI

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Licentie

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

Engels

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

1 Formulieren  
Identification
Beschrijving

Identification

Alias
UMLS CUI-1
C1300638
Center number
Beschrijving

Center number

Datatype

text

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

Subject ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Beschrijving

Treatment Number

Datatype

text

Alias
UMLS CUI [1]
C1522541
Date of birth
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschrijving

Gender

Datatype

text

Alias
UMLS CUI [1]
C0079399
Date of vaccination
Beschrijving

Vaccination Date

Datatype

date

Alias
UMLS CUI [1]
C1115436
Local Symptoms (At Injection Sites)
Beschrijving

Local Symptoms (At Injection Sites)

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Type of Vaccine Administered
Beschrijving

for investigator only

Datatype

integer

Alias
UMLS CUI [1]
C0087111
Injection side
Beschrijving

for investigator only

Datatype

text

Alias
UMLS CUI [1]
C0441987
Injection site
Beschrijving

for investigator only

Datatype

integer

Alias
UMLS CUI [1]
C1515974
Local Symptoms
Beschrijving

Local Symptoms

Datatype

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Symptom Size/Intensity Day 0
Beschrijving

SIZE: Please measure the areatest diameter (in mm). Please contact the study personnel if your child experiences any symptom that raises concern, including injection site puffiness (swelling) diameter >50mm; widespread puffiness (diffuse swelling) or if the size of the injected limb increases (increased limb circumference). Pain 0: Absent 1: Minor reaction to touch interfering with everyday activities. 2: Cries/protests on touch 3: Cries when limb is moved Other local Symptoms 1 :Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not 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 spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center andwould cause the parents/guardians to seek. medical advice).

Datatype

text

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2]
C0518690
Symptom Size/Intensity Day 1
Beschrijving

SIZE: Please measure the areatest diameter (in mm). Please contact the study personnel if your child experiences any symptom that raises concern, including injection site puffiness (swelling) diameter >50mm; widespread puffiness (diffuse swelling) or if the size of the injected limb increases (increased limb circumference). Pain 0: Absent 1: Minor reaction to touch interfering with everyday activities. 2: Cries/protests on touch 3: Cries when limb is moved Other local Symptoms 1 :Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not 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 spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center andwould cause the parents/guardians to seek. medical advice).

Datatype

text

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2]
C0518690
Symptom Size/Intensity Day 2
Beschrijving

SIZE: Please measure the areatest diameter (in mm). Please contact the study personnel if your child experiences any symptom that raises concern, including injection site puffiness (swelling) diameter >50mm; widespread puffiness (diffuse swelling) or if the size of the injected limb increases (increased limb circumference). Pain 0: Absent 1: Minor reaction to touch interfering with everyday activities. 2: Cries/protests on touch 3: Cries when limb is moved Other local Symptoms 1 :Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not 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 spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center andwould cause the parents/guardians to seek. medical advice).

Datatype

text

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2]
C0518690
Symptom Size/Intensity Day 3
Beschrijving

SIZE: Please measure the areatest diameter (in mm). Please contact the study personnel if your child experiences any symptom that raises concern, including injection site puffiness (swelling) diameter >50mm; widespread puffiness (diffuse swelling) or if the size of the injected limb increases (increased limb circumference). Pain 0: Absent 1: Minor reaction to touch interfering with everyday activities. 2: Cries/protests on touch 3: Cries when limb is moved Other local Symptoms 1 :Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not 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 spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center andwould cause the parents/guardians to seek. medical advice).

Datatype

text

Alias
UMLS CUI [1]
C0456389
UMLS CUI [2]
C0518690
Ongoing after Day 3
Beschrijving

Ongoing after Day 3

Datatype

boolean

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

Date of last Symptoms

Datatype

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0011008
Medically Attended visit
Beschrijving

Medically Attended visit

Datatype

boolean

Alias
UMLS CUI [1]
C0545082
Other Local Symptoms
Beschrijving

Other Local Symptoms

Description - please specify side(s) and site(s)
Beschrijving

Description - please specify side(s) and site(s)

Datatype

text

Alias
UMLS CUI [1]
C0441987
UMLS CUI [2]
C1515974
Intensity
Beschrijving

Intensity

Datatype

integer

Alias
UMLS CUI [1]
C0522510
Start date
Beschrijving

Start date

Datatype

date

Maateenheden
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date
Beschrijving

End date

Datatype

date

Maateenheden
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Is the symptom persistent?
Beschrijving

Ongoing

Datatype

boolean

Alias
UMLS CUI [1]
C0549178
Medically Attended visit
Beschrijving

Medically Attended visit

Datatype

boolean

Alias
UMLS CUI [1]
C0545082
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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Local Symptoms (At Injection Sites)
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Item
Type of Vaccine Administered
integer
C0087111 (UMLS CUI [1])
Type of Vaccine Administered
Code List
Type of Vaccine Administered
CL Item
10Pn-PD-DiT or Prevenar vaccine (1)
CL Item
DTPa-HBV-IPV/Hib vaccine (2)
Item
Injection side
text
C0441987 (UMLS CUI [1])
Injection side
Code List
Injection side
CL Item
Left  (L)
CL Item
Right (R)
Item
Injection site
integer
C1515974 (UMLS CUI [1])
Injection site
Code List
Injection site
CL Item
Arm (1)
CL Item
thigh (3)
CL Item
buttock (6)
Item
Local Symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local Symptoms
Code List
Local Symptoms
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Symptom Size/Intensity Day 0
Item
Symptom Size/Intensity Day 0
text
C0456389 (UMLS CUI [1])
C0518690 (UMLS CUI [2])
Symptom Size/Intensity Day 1
Item
Symptom Size/Intensity Day 1
text
C0456389 (UMLS CUI [1])
C0518690 (UMLS CUI [2])
Symptom Size/Intensity Day 2
Item
Symptom Size/Intensity Day 2
text
C0456389 (UMLS CUI [1])
C0518690 (UMLS CUI [2])
Symptom Size/Intensity Day 3
Item
Symptom Size/Intensity Day 3
text
C0456389 (UMLS CUI [1])
C0518690 (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 Local Symptoms
Description - please specify side(s) and site(s)
Item
Description - please specify side(s) and site(s)
text
C0441987 (UMLS CUI [1])
C1515974 (UMLS CUI [2])
Item
Intensity
integer
C0522510 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek. medical advice). (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Ongoing
Item
Is the symptom persistent?
boolean
C0549178 (UMLS CUI [1])
Medically Attended visit
Item
Medically Attended visit
boolean
C0545082 (UMLS CUI [1])
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