ID

14926

Beschreibung

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: Adverse Events

Stichworte

Versionen (1)
  1. 08.05.16 08.05.16 -
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8. Mai 2016

DOI

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Adverse Events Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

Englisch

Adverse Events "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulare  
Identification
Beschreibung

Identification

Alias
UMLS CUI-1
C1300638
Center number
Beschreibung

Center number

Datentyp

text

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

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Beschreibung

Treatment Number

Datentyp

text

Alias
UMLS CUI [1]
C1522541
Visit Number
Beschreibung

Visit Number

Datentyp

integer

Alias
UMLS CUI [1]
C0545082
Local Symptoms
Beschreibung

Local Symptoms

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

Type of Vaccine Administered

Datentyp

integer

Alias
UMLS CUI [1]
C0087111
Local Symptoms
Beschreibung

If yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. If any of these adverse events meets the protocol definition of serious, please complete a Serious Adverse Event report and fax to GSK Biologicals Study Contact for SAE reporting within 24 hours.

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Type of symptoms
Beschreibung

In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.

Datentyp

text

Alias
UMLS CUI [1]
C1457887
Size/Intensity Day 0
Beschreibung

Intensity: 0,1,2,3 (see Adverse Events definitions)

Datentyp

text

Alias
UMLS CUI [1]
C0005890
UMLS CUI [2]
C0518690
Size/Intensity Day 1
Beschreibung

Intensity: 0,1,2,3 (see Adverse Events definitions)

Datentyp

text

Alias
UMLS CUI [1]
C0005890
UMLS CUI [2]
C0518690
Size/Intensity Day 2
Beschreibung

Intensity: 0,1,2,3 (see Adverse Events definitions)

Datentyp

text

Alias
UMLS CUI [1]
C0005890
UMLS CUI [2]
C0518690
Size/Intensity Day 3
Beschreibung

Intensity: 0,1,2,3 (see Adverse Events definitions)

Datentyp

text

Alias
UMLS CUI [1]
C0005890
UMLS CUI [2]
C0518690
Ongoing after Day 3
Beschreibung

If yes name date of last Symptoms below

Datentyp

boolean

Alias
UMLS CUI [1]
C0449238
Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

Alias
UMLS CUI [1]
C2004454
Medically attended visit
Beschreibung

if yes, please specify the place below

Datentyp

boolean

Alias
UMLS CUI [1]
C0545082
Facility of Medical Attendance
Beschreibung

Place of Medical Attendance

Datentyp

text

Alias
UMLS CUI [1]
C0018704
General Symptoms
Beschreibung

General Symptoms

Has the subject experienced any of the following signs/symptoms during the solicited period
Beschreibung

If Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items.

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205246
General Symptoms specification
Beschreibung

General Symptoms specification

General Symptom
Beschreibung

If Fever, please specify below.

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205246
Fever Measuring Route
Beschreibung

Fever Measuring Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Intensity/°C Day 0
Beschreibung

Fever: Axillary >37.5°C Oral >37.5°C Rectal >38.0°C Tympanic (oral conversion) >37.5°C Tympanic (rectal conversion) >38.0°C Intensity: 0,1,2,3

Datentyp

text

Alias
UMLS CUI [1]
C0518690
UMLS CUI [2]
C0039476
Intensity/°C Day 1
Beschreibung

Intensity/°C Day 1

Datentyp

text

Intensity/°C Day 2
Beschreibung

Intensity/°C Day 2

Datentyp

text

Intensity/°C Day 0
Beschreibung

Intensity/°C Day 3

Datentyp

text

Ongiong after Day 3
Beschreibung

Ongiong after Day 3

Datentyp

text

Date of last day of symptoms
Beschreibung

Date of last day of symptoms

Datentyp

date

Alias
UMLS CUI [1]
C2004454
Casualty
Beschreibung

Casualty

Datentyp

boolean

Alias
UMLS CUI [1]
C0011065
Medically Attended visit
Beschreibung

Medically Attended visit

Datentyp

boolean

Alias
UMLS CUI [1]
C0545082
Visited Facility
Beschreibung

Health Care Facility

Datentyp

text

Alias
UMLS CUI [1]
C0018704
Unsolicited Adverse Events
Beschreibung

Unsolicited Adverse Events

Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination
Beschreibung

If Yes: Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary.

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Has the subject experienced any meningitis ?
Beschreibung

Meningitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0025289
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Ähnliche Modelle

Adverse Events "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 Group
Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Item
Type of Vaccine Administered
integer
C0087111 (UMLS CUI [1])
Type of Vaccine Adiministered
Code List
Type of Vaccine Administered
CL Item
10Pn-PD-DiT or Prevenar vaccine (1)
CL Item
DTPa-HBV-IPV/Hib vaccine (2)
Item
Local Symptoms
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local Symptoms 1 OPn-PD-DiT or Prevenar vaccine
Code List
Local Symptoms
CL Item
No  (N)
CL Item
Information not available  (U)
CL Item
No vaccine administered (NA)
CL Item
Yes (Y)
Item
Type of symptoms
text
C1457887 (UMLS CUI [1])
Type of symptoms
Code List
Type of symptoms
CL Item
Redness (RE)
CL Item
Swelling (SW)
CL Item
Pain (PA)
Size/Intensity Day 0
Item
Size/Intensity Day 0
text
C0005890 (UMLS CUI [1])
C0518690 (UMLS CUI [2])
Size/Intensity Day 1
Item
Size/Intensity Day 1
text
C0005890 (UMLS CUI [1])
C0518690 (UMLS CUI [2])
Size/Intensity Day 2
Item
Size/Intensity Day 2
text
C0005890 (UMLS CUI [1])
C0518690 (UMLS CUI [2])
Size/Intensity Day 3
Item
Size/Intensity Day 3
text
C0005890 (UMLS CUI [1])
C0518690 (UMLS CUI [2])
Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0449238 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C2004454 (UMLS CUI [1])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1])
Item
Facility of Medical Attendance
text
C0018704 (UMLS CUI [1])
Place of Medical Attendance
Code List
Facility of Medical Attendance
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item Group
General Symptoms
Item
Has the subject experienced any of the following signs/symptoms during the solicited period
text
C1457887 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Has subject had Symptoms
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
General Symptoms specification
Item
General Symptom
text
C1457887 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
GENERAL SYMPTOM
Code List
General Symptom
CL Item
Fever (FE)
CL Item
Irritablity/Fussiness (IR)
CL Item
Drowsiness (DR)
CL Item
Loss of appetite (LO)
Item
Fever Measuring Route
text
C0013153 (UMLS CUI [1])
Fever Measuring Route
Code List
Fever Measuring Route
CL Item
Axillary  (A)
CL Item
Oral (O)
CL Item
Rectal (R)
CL Item
Tympanic Oral (X)
CL Item
Tympanic Rectal (Y)
Intensity/°C Day 0
Item
Intensity/°C Day 0
text
C0518690 (UMLS CUI [1])
C0039476 (UMLS CUI [2])
Intensity/°C Day 1
Item
Intensity/°C Day 1
text
Intensity/°C Day 2
Item
Intensity/°C Day 2
text
Intensity/°C Day 3
Item
Intensity/°C Day 0
text
Ongiong after Day 3
Item
Ongiong after Day 3
text
Date of last day of symptoms
Item
Date of last day of symptoms
date
C2004454 (UMLS CUI [1])
Casualty
Item
Casualty
boolean
C0011065 (UMLS CUI [1])
Medically Attended visit
Item
Medically Attended visit
boolean
C0545082 (UMLS CUI [1])
Item
Visited Facility
text
C0018704 (UMLS CUI [1])
Health Care Facility
Code List
Visited Facility
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item Group
Unsolicited Adverse Events
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination
text
C0877248 (UMLS CUI [1])
unsolicited adverse events one month post-vaccination
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Meningitis
Item
Has the subject experienced any meningitis ?
boolean
C0025289 (UMLS CUI [1])
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