ID
14997
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: Local Symptoms
Stichworte
Versionen (2)
- 10.05.16 10.05.16 -
- 11.05.16 11.05.16 -
Hochgeladen am
11. Mai 2016
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Diary Card: Local Symptoms Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396
Diary Card: Local Symptoms "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Beschreibung
Local Symptoms (At Injection Sites)
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Beschreibung
for investigator only
Datentyp
integer
Alias
- UMLS CUI [1]
- C0087111
Beschreibung
for investigator only
Datentyp
text
Alias
- UMLS CUI [1]
- C0441987
Beschreibung
for investigator only
Datentyp
integer
Alias
- UMLS CUI [1]
- C1515974
Beschreibung
Local Symptoms
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beschreibung
SIZE: Please measure the areatest diameter (in mm). Please contact the study personnel if your child experiences any symptom that raises concern, including injection site puffiness (swelling) diameter >50mm; widespread puffiness (diffuse swelling) or if the size of the injected limb increases (increased limb circumference). Pain 0: Absent 1: Minor reaction to touch interfering with everyday activities. 2: Cries/protests on touch 3: Cries when limb is moved Other local Symptoms 1 :Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not 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 spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center andwould cause the parents/guardians to seek. medical advice).
Datentyp
text
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2]
- C0518690
Beschreibung
SIZE: Please measure the areatest diameter (in mm). Please contact the study personnel if your child experiences any symptom that raises concern, including injection site puffiness (swelling) diameter >50mm; widespread puffiness (diffuse swelling) or if the size of the injected limb increases (increased limb circumference). Pain 0: Absent 1: Minor reaction to touch interfering with everyday activities. 2: Cries/protests on touch 3: Cries when limb is moved Other local Symptoms 1 :Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not 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 spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center andwould cause the parents/guardians to seek. medical advice).
Datentyp
text
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2]
- C0518690
Beschreibung
SIZE: Please measure the areatest diameter (in mm). Please contact the study personnel if your child experiences any symptom that raises concern, including injection site puffiness (swelling) diameter >50mm; widespread puffiness (diffuse swelling) or if the size of the injected limb increases (increased limb circumference). Pain 0: Absent 1: Minor reaction to touch interfering with everyday activities. 2: Cries/protests on touch 3: Cries when limb is moved Other local Symptoms 1 :Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not 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 spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center andwould cause the parents/guardians to seek. medical advice).
Datentyp
text
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2]
- C0518690
Beschreibung
SIZE: Please measure the areatest diameter (in mm). Please contact the study personnel if your child experiences any symptom that raises concern, including injection site puffiness (swelling) diameter >50mm; widespread puffiness (diffuse swelling) or if the size of the injected limb increases (increased limb circumference). Pain 0: Absent 1: Minor reaction to touch interfering with everyday activities. 2: Cries/protests on touch 3: Cries when limb is moved Other local Symptoms 1 :Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not 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 spontaneously painful event would, for example, prevent attendance at school/kindergarten/a day-care center andwould cause the parents/guardians to seek. medical advice).
Datentyp
text
Alias
- UMLS CUI [1]
- C0456389
- UMLS CUI [2]
- C0518690
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 Local Symptoms
Beschreibung
Description - please specify side(s) and site(s)
Datentyp
text
Alias
- UMLS CUI [1]
- C0441987
- UMLS CUI [2]
- C1515974
Beschreibung
Intensity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0522510
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
Ongoing
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0549178
Beschreibung
Medically Attended visit
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0545082
Ähnliche Modelle
Diary Card: Local Symptoms "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
C0805701 (UMLS CUI [1,2])
C0205276 (UMLS CUI-2)
C0518690 (UMLS CUI [2])
C0518690 (UMLS CUI [2])
C0518690 (UMLS CUI [2])
C0518690 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2])