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)
- 08.05.16 08.05.16 -
Hochgeladen am
8. Mai 2016
DOI
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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
Beschreibung
Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Beschreibung
Type of Vaccine Administered
Datentyp
integer
Alias
- UMLS CUI [1]
- C0087111
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
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
Beschreibung
Intensity: 0,1,2,3 (see Adverse Events definitions)
Datentyp
text
Alias
- UMLS CUI [1]
- C0005890
- UMLS CUI [2]
- C0518690
Beschreibung
Intensity: 0,1,2,3 (see Adverse Events definitions)
Datentyp
text
Alias
- UMLS CUI [1]
- C0005890
- UMLS CUI [2]
- C0518690
Beschreibung
Intensity: 0,1,2,3 (see Adverse Events definitions)
Datentyp
text
Alias
- UMLS CUI [1]
- C0005890
- UMLS CUI [2]
- C0518690
Beschreibung
Intensity: 0,1,2,3 (see Adverse Events definitions)
Datentyp
text
Alias
- UMLS CUI [1]
- C0005890
- UMLS CUI [2]
- C0518690
Beschreibung
If yes name date of last Symptoms below
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0449238
Beschreibung
Date of last day of symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C2004454
Beschreibung
if yes, please specify the place below
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Place of Medical Attendance
Datentyp
text
Alias
- UMLS CUI [1]
- C0018704
Beschreibung
General Symptoms
Beschreibung
General Symptoms specification
Beschreibung
If Fever, please specify below.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205246
Beschreibung
Fever Measuring Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
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
Beschreibung
Intensity/°C Day 1
Datentyp
text
Beschreibung
Intensity/°C Day 2
Datentyp
text
Beschreibung
Intensity/°C Day 3
Datentyp
text
Beschreibung
Ongiong after Day 3
Datentyp
text
Beschreibung
Date of last day of symptoms
Datentyp
date
Alias
- UMLS CUI [1]
- C2004454
Beschreibung
Casualty
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschreibung
Medically Attended visit
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Health Care Facility
Datentyp
text
Alias
- UMLS CUI [1]
- C0018704
Beschreibung
Unsolicited Adverse Events
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
Beschreibung
Meningitis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0025289
Ähnliche Modelle
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])