ID
14967
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: Diary Card: General Symptoms
Nyckelord
Versioner (3)
- 2016-05-10 2016-05-10 -
- 2016-05-11 2016-05-11 -
- 2021-09-20 2021-09-20 -
Uppladdad den
10 maj 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Diary Card: General Symptoms "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Diary Card: General Symptoms "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Beskrivning
General Symptoms
Alias
- UMLS CUI-1
- C1457887
Beskrivning
Please fill in below and assess the occurrence of any of the followinq siqns or symptoms accordinq to the criteria listed hereafter: Temperature: Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value for the day. Intensity: Irritability / fussiness: 0: Behavior as usual Drowsiness: Loss of appetite: 0: Behavior as usual 0: Appetite as usual 1: Crying more than usual I no effect on normal activity 2: Crying more than usual I interferes with normal activity 3: Crying that cannot be comforted I prevents normal 1: Drowsiness easily tolerated 2: Drowsiness that interferes with normal activity 3:Drowsiness that prevents normal activity 1: Eating less than usual I no effect on normal activity activity 2: Eating less than usual I interferes with normal activity 3: Not eating at all Other general svmptoms: 1:Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 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 event would, for example, prevent attendance at school/kinderqarten/a day-care center and would cause the parents/guardians to seek medical advice).
Datatyp
integer
Alias
- UMLS CUI [1]
- C1457887
Beskrivning
Temperature / Intensity Day 0
Datatyp
text
Alias
- UMLS CUI [1]
- C0518690
- UMLS CUI [2]
- C0039476
Beskrivning
Temperature Measurement site
Datatyp
integer
Alias
- UMLS CUI [1]
- C1515974
Beskrivning
Temperature / Intensity Day 1
Datatyp
text
Alias
- UMLS CUI [1]
- C0518690
- UMLS CUI [2]
- C0039476
Beskrivning
Temperature / Intensity Day 2
Datatyp
text
Alias
- UMLS CUI [1]
- C0518690
- UMLS CUI [2]
- C0039476
Beskrivning
Temperature / Intensity Day 3
Datatyp
text
Alias
- UMLS CUI [1]
- C0518690
- UMLS CUI [2]
- C0039476
Beskrivning
Ongoing after Day 3
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0449238
Beskrivning
Date of last Symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0011008
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0545082
Beskrivning
Other General Symptoms
Alias
- UMLS CUI-1
- C1457887
Beskrivning
Description
Datatyp
text
Alias
- UMLS CUI [1]
- C0678257
Beskrivning
Intensity
Datatyp
integer
Alias
- UMLS CUI [1]
- C0522510
Beskrivning
Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
End date
Datatyp
date
Måttenheter
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
Medically attended visit
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0545082
Beskrivning
Medication
Alias
- UMLS CUI-1
- C0013227
Beskrivning
Name
Datatyp
text
Alias
- UMLS CUI [1]
- C0027365
Beskrivning
Reason
Datatyp
text
Alias
- UMLS CUI [1]
- C0392360
Beskrivning
total daily dose
Datatyp
text
Måttenheter
- mg
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
Start date
Datatyp
date
Måttenheter
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
End date
Datatyp
date
Måttenheter
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
Continuing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0750536
Beskrivning
Administration
Similar models
Diary Card: General Symptoms "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
C0805701 (UMLS CUI [1,2])
C0039476 (UMLS CUI [2])
C0039476 (UMLS CUI [2])
C0039476 (UMLS CUI [2])
C0039476 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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