ID

15001

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: Medication

Stichworte

Versionen (2)
  1. 09.05.16 09.05.16 -
  2. 11.05.16 11.05.16 -
Hochgeladen am

11. Mai 2016

DOI

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Creative Commons BY-NC 3.0
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Medication Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

Englisch

Medication "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulare  
Identification
Beschreibung

Identification

Alias
UMLS CUI-1
C1300638
Center number
Beschreibung

Center number

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0805701
Subject ID
Beschreibung

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Beschreibung

Treatment Number

Datentyp

text

Alias
UMLS CUI [1]
C1522541
Visit Number
Beschreibung

Visit Number

Datentyp

integer

Alias
UMLS CUI [1]
C0545082
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
Have any medications/treatments been administered during study period?
Beschreibung

If yes, please complete the following table.

Datentyp

boolean

Alias
UMLS CUI [1]
C0011008
UMLS CUI [2]
C0087111
Medication List
Beschreibung

Medication List

Trade / Generic Name
Beschreibung

Trade / Generic Name

Datentyp

text

Alias
UMLS CUI [1]
C0027365
Medical Indication
Beschreibung

Medical Indication

Datentyp

text

Alias
UMLS CUI [1]
C2315323
Prophylactic treatment
Beschreibung

Prophylactic treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0199176
Total daily dose
Beschreibung

Total daily dose

Datentyp

text

Alias
UMLS CUI [1]
C3174092
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Start Date of Medication
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
End Date of Medication
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
End Date is End Date of Study
Beschreibung

End Date is End Date of Study

Datentyp

boolean

Alias
UMLS CUI [1]
C0806020
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Ähnliche Modelle

Medication "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Identification
C1300638 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Item
Visit Number
integer
C0545082 (UMLS CUI [1])
Visit Number
Code List
Visit Number
CL Item
1 (1)
CL Item
2 (2)
Item Group
Medication
C0013227 (UMLS CUI-1)
medications/treatments during study period?
Item
Have any medications/treatments been administered during study period?
boolean
C0011008 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Item Group
Medication List
Trade / Generic Name
Item
Trade / Generic Name
text
C0027365 (UMLS CUI [1])
Medical Indication
Item
Medical Indication
text
C2315323 (UMLS CUI [1])
Prophylactic treatment
Item
Prophylactic treatment
boolean
C0199176 (UMLS CUI [1])
Total daily dose
Item
Total daily dose
text
C3174092 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
External (EXT)
CL Item
lntradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
lntraarticular (IR)
CL Item
lntrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublinqual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaqinal (VA)
Start Date
Item
Start Date of Medication
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date of Medication
date
C0806020 (UMLS CUI [1])
End Date is End Date of Study
Item
End Date is End Date of Study
boolean
C0806020 (UMLS CUI [1])
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