ID
14926
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: Adverse Events
Nyckelord
Versioner (1)
- 2016-05-08 2016-05-08 -
Uppladdad den
8 maj 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Adverse Events Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396
Adverse Events "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Beskrivning
Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Beskrivning
Type of Vaccine Administered
Datatyp
integer
Alias
- UMLS CUI [1]
- C0087111
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beskrivning
In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.
Datatyp
text
Alias
- UMLS CUI [1]
- C1457887
Beskrivning
Intensity: 0,1,2,3 (see Adverse Events definitions)
Datatyp
text
Alias
- UMLS CUI [1]
- C0005890
- UMLS CUI [2]
- C0518690
Beskrivning
Intensity: 0,1,2,3 (see Adverse Events definitions)
Datatyp
text
Alias
- UMLS CUI [1]
- C0005890
- UMLS CUI [2]
- C0518690
Beskrivning
Intensity: 0,1,2,3 (see Adverse Events definitions)
Datatyp
text
Alias
- UMLS CUI [1]
- C0005890
- UMLS CUI [2]
- C0518690
Beskrivning
Intensity: 0,1,2,3 (see Adverse Events definitions)
Datatyp
text
Alias
- UMLS CUI [1]
- C0005890
- UMLS CUI [2]
- C0518690
Beskrivning
If yes name date of last Symptoms below
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0449238
Beskrivning
Date of last day of symptoms
Datatyp
date
Alias
- UMLS CUI [1]
- C2004454
Beskrivning
if yes, please specify the place below
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0545082
Beskrivning
Place of Medical Attendance
Datatyp
text
Alias
- UMLS CUI [1]
- C0018704
Beskrivning
General Symptoms
Beskrivning
General Symptoms specification
Beskrivning
If Fever, please specify below.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205246
Beskrivning
Fever Measuring Route
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1]
- C0518690
- UMLS CUI [2]
- C0039476
Beskrivning
Intensity/°C Day 1
Datatyp
text
Beskrivning
Intensity/°C Day 2
Datatyp
text
Beskrivning
Intensity/°C Day 3
Datatyp
text
Beskrivning
Ongiong after Day 3
Datatyp
text
Beskrivning
Date of last day of symptoms
Datatyp
date
Alias
- UMLS CUI [1]
- C2004454
Beskrivning
Casualty
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011065
Beskrivning
Medically Attended visit
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0545082
Beskrivning
Health Care Facility
Datatyp
text
Alias
- UMLS CUI [1]
- C0018704
Beskrivning
Unsolicited Adverse Events
Beskrivning
If Yes: Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary.
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Meningitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0025289
Similar models
Adverse Events "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
C0805701 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2])
C0518690 (UMLS CUI [2])
C0518690 (UMLS CUI [2])
C0518690 (UMLS CUI [2])
C0205246 (UMLS CUI [1,2])
C0039476 (UMLS CUI [2])