ID

14999

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: Large Swelling Reaction

Trefwoorden

Versies (3)
  1. 09-05-16 09-05-16 -
  2. 10-05-16 10-05-16 - Julian Varghese
  3. 11-05-16 11-05-16 -
Geüploaded op

11 mei 2016

DOI

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Creative Commons BY-NC 3.0
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Large Swelling Reaction Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

Engels

Large Swelling Reaction "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
Visit Number
Beschrijving

Visit Number

Datatype

integer

Alias
UMLS CUI [1]
C0545082
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]
C0002092
Report of physical examination
Beschrijving

Report of physical examination

Alias
UMLS CUI-1
C0031809
Date of physical examination
Beschrijving

Date of physical examination

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0031809
Was the examination performed by a member of study personnel during the large swelling reaction period:
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0025082
Date when the swelling was first considered to be a large swelling reaction:
Beschrijving

If hospitalization is required, please also complete a Serious Adverse Event (SAE) Form and contact GlaxoSmithKline Biologicals within 24 hours after becoming aware of the SAE.

Datatype

date

Alias
UMLS CUI [1]
C2316983
If occurring within 24 hours after vaccination, please I I I hours specify how loni:i after vaccination:
Beschrijving

Hours after Event

Datatype

text

Alias
UMLS CUI [1]
C0040223
Size of swelling
Beschrijving

Size of swelling

Datatype

text

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
Type of swelling
Beschrijving

Please specify in section 7

Datatype

integer

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

Circumference of affected site

Datatype

text

Alias
UMLS CUI [1,1]
C0332520
UMLS CUI [1,2]
C0449642
Circumference of the opposite limb (at the same level):
Beschrijving

Circumference of the opposite site

Datatype

text

Alias
UMLS CUI [1,1]
C0332520
UMLS CUI [1,2]
C1708335
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 occurring during the extensive swelling period. If other symptoms are associated lnduration with the large swelling reaction please specify under section

Datatype

text

Alias
UMLS CUI [1]
C0039476
Route of temperature Measurement
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Associated signs: Redness
Beschrijving

If yes, please specify diameter below.

Datatype

boolean

Alias
UMLS CUI [1]
C0332575
Redness Diameter
Beschrijving

Redness Diameter

Datatype

float

Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332575
lnduration
Beschrijving

If yes, plase specify diameter below.

Datatype

boolean

Alias
UMLS CUI [1]
C0332534
Largest Diameter of Induration
Beschrijving

Largest Diameter of Induration

Datatype

text

Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0332534
Pain
Beschrijving

Pain

Datatype

boolean

Alias
UMLS CUI [1]
C0030193
Pain Intensity
Beschrijving

Intensity of pain at injection site grade 1: Minor reaction to touch grade 2: Cries/protests on touch grade 3: Cries when limb is moved/spontaneously painful

Datatype

integer

Alias
UMLS CUI [1]
C1320357
Functional impairment
Beschrijving

Functional impairment

Datatype

partialDatetime

Alias
UMLS CUI [1]
C0012605
Intensity of functional impairment
Beschrijving

Intensity of functional impairment: Grade 1: Easily tolerated, causing minimal discomfort and not interfering with everyday activities Grade 2: Sufficiently discomforting to interfere with normal everyday activities Grade 3: Prevents normal everyday activities

Datatype

integer

Alias
UMLS CUI [1,1]
C0012605
UMLS CUI [1,2]
C0439793
Clinical case descri tion and outcome of the adverse event
Beschrijving

Clinical case descri tion and outcome of the adverse event

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 diagnostic(s) procedures and thera eutic interventions.

Datatype

text

Alias
UMLS CUI [1]
C0449437
Last date when the swelling was still considered to be large swellin reaction:
Beschrijving

Last date when the swelling was still considered to be large swellin reaction:

Datatype

date

Alias
UMLS CUI [1]
C0449238
Duration (hours)
Beschrijving

If lasting for less than 24 hours, please specify duration (hours)

Datatype

time

Alias
UMLS CUI [1]
C0449238
Outcome of the large swelling reaction:
Beschrijving

If Not recovered / not resolved, please provide further follow-up data If Recovered with sequelae / resolved with sequelae, please specify under section 7

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Is there an alternative explanation for the swelling?
Beschrijving

(e.g.: allergy, infection, trauma, under/ in conditions) if yes, please specify below

Datatype

boolean

Alias
UMLS CUI [1]
C0681841
Alternative Explanation: Specification
Beschrijving

Alternative Explanation: Specification

Datatype

text

Alias
UMLS CUI [1]
C0681841
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Similar models

Large Swelling Reaction "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])
Item
Visit Number
integer
C0545082 (UMLS CUI [1])
Visit Number
Code List
Visit Number
CL Item
1 (1)
CL Item
2 (2)
Item
Vaccine administered for which the large swelling reaction reported:
integer
C0002092 (UMLS CUI [1])
Vaccine administered for which the large swelling reaction reported:
Code List
Vaccine administered for which the large swelling reaction reported:
CL Item
1 OPn-PD-DiT Vaccine or Prevenar Vaccine (901)
CL Item
DTPa-HBV-IPV/Hib Vaccine (93)
Item Group
Report of physical examination
C0031809 (UMLS CUI-1)
Date of physical examination
Item
Date of physical examination
date
C0011008 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
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
C0025082 (UMLS CUI [1])
Date of Diagnosis
Item
Date when the swelling was first considered to be a large swelling reaction:
date
C2316983 (UMLS CUI [1])
Hours after Event
Item
If occurring within 24 hours after vaccination, please I I I hours specify how loni:i after vaccination:
text
C0040223 (UMLS CUI [1])
Size of swelling
Item
Size of swelling
text
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
Type of swelling
integer
C0038999 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of swelling
Code List
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)
Circumference of affected site
Item
Circumference of swollen limb (at the site of maximum swelling)
text
C0332520 (UMLS CUI [1,1])
C0449642 (UMLS CUI [1,2])
Circumference of the opposite site
Item
Circumference of the opposite limb (at the same level):
text
C0332520 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
Associated signs: Temperature
Item
Associated signs: Temperature
text
C0039476 (UMLS CUI [1])
Item
Route of temperature Measurement
text
C0013153 (UMLS CUI [1])
Route
Code List
Route of temperature Measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
CL Item
Tympanic oral (X)
CL Item
Tympanic rectal (Y)
Associated signs: Redness
Item
Associated signs: Redness
boolean
C0332575 (UMLS CUI [1])
Redness Diameter
Item
float
C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
lnduration
Item
lnduration
boolean
C0332534 (UMLS CUI [1])
Largest Diameter of Induration
Item
Largest Diameter of Induration
text
C0456389 (UMLS CUI [1,1])
C0332534 (UMLS CUI [1,2])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1])
Item
Pain Intensity
integer
C1320357 (UMLS CUI [1])
Pain
Code List
Pain Intensity
CL Item
grade 1  (1)
CL Item
grade 2 (2)
CL Item
grade 3 (3)
Functional impairment
Item
Functional impairment
partialDatetime
C0012605 (UMLS CUI [1])
Item
Intensity of functional impairment
integer
C0012605 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Intensity of functional impairment
Code List
Intensity of functional impairment
CL Item
Grade 1 (1)
CL Item
Grade 2  (2)
CL Item
Grade 3 (3)
Item Group
Clinical case descri tion and outcome of the adverse event
Case description
Item
Case description
text
C0449437 (UMLS CUI [1])
Last date when the swelling was still considered to be large swellin reaction:
Item
Last date when the swelling was still considered to be large swellin reaction:
date
C0449238 (UMLS CUI [1])
Duration (hours)
Item
Duration (hours)
time
C0449238 (UMLS CUI [1])
Item
Outcome of the large swelling reaction:
integer
C1705586 (UMLS CUI [1])
Outcome of the large swelling reaction:
Code List
Outcome of the large swelling reaction:
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved  (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Alternative Explanation
Item
Is there an alternative explanation for the swelling?
boolean
C0681841 (UMLS CUI [1])
Alternative Explanation: Specification
Item
Alternative Explanation: Specification
text
C0681841 (UMLS CUI [1])
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