ID
43869
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: Diary Card: General Symptoms
Stichworte
Versionen (3)
- 10.05.16 10.05.16 -
- 11.05.16 11.05.16 -
- 20.09.21 20.09.21 -
Hochgeladen am
20. September 2021
DOI
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Lizenz
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
Beschreibung
General Symptoms
Alias
- UMLS CUI-1
- C1457887
Beschreibung
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).
Datentyp
integer
Alias
- UMLS CUI [1]
- C1457887
Beschreibung
Temperature / Intensity Day 0
Datentyp
text
Alias
- UMLS CUI [1]
- C0518690
- UMLS CUI [2]
- C0039476
Beschreibung
Temperature Measurement site
Datentyp
integer
Alias
- UMLS CUI [1]
- C1515974
Beschreibung
Temperature / Intensity Day 1
Datentyp
text
Alias
- UMLS CUI [1]
- C0518690
- UMLS CUI [2]
- C0039476
Beschreibung
Temperature / Intensity Day 2
Datentyp
text
Alias
- UMLS CUI [1]
- C0518690
- UMLS CUI [2]
- C0039476
Beschreibung
Temperature / Intensity Day 3
Datentyp
text
Alias
- UMLS CUI [1]
- C0518690
- UMLS CUI [2]
- C0039476
Beschreibung
Ongoing after Day 3
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0449238
Beschreibung
Date of last Symptoms
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0011008
Beschreibung
Medically attended visit
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Other General Symptoms
Alias
- UMLS CUI-1
- C1457887
Beschreibung
Description
Datentyp
text
Alias
- UMLS CUI [1]
- C0678257
Beschreibung
Intensity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0522510
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End date
Datentyp
date
Maßeinheiten
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Medically attended visit
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Medication
Alias
- UMLS CUI-1
- C0013227
Beschreibung
Name
Datentyp
text
Alias
- UMLS CUI [1]
- C0027365
Beschreibung
Reason
Datentyp
text
Alias
- UMLS CUI [1]
- C0392360
Beschreibung
total daily dose
Datentyp
text
Maßeinheiten
- mg
Alias
- UMLS CUI [1]
- C2348070
Beschreibung
Start date
Datentyp
date
Maßeinheiten
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
End date
Datentyp
date
Maßeinheiten
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Continuing
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0549178
Beschreibung
Administration
Ähnliche Modelle
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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