ID

14940

Descripción

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

Palabras clave

Versiones (2)
  1. 9/5/16 9/5/16 -
  2. 11/5/16 11/5/16 -
Subido en

9 de mayo de 2016

DOI

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Licencia

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

Inglés

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

1 formularios  
Identification
Descripción

Identification

Alias
UMLS CUI-1
C1300638
Center number
Descripción

Center number

Tipo de datos

text

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

Subject ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Descripción

Treatment Number

Tipo de datos

text

Alias
UMLS CUI [1]
C1522541
Visit Number
Descripción

Visit Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C0545082
Medication
Descripción

Medication

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

If yes, please complete the following table.

Tipo de datos

boolean

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

Medication List

Trade / Generic Name
Descripción

Trade / Generic Name

Tipo de datos

text

Alias
UMLS CUI [1]
C0027365
Medical Indication
Descripción

Medical Indication

Tipo de datos

text

Alias
UMLS CUI [1]
C2315323
Prophylactic treatment
Descripción

Prophylactic treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0199176
Total daily dose
Descripción

Total daily dose

Tipo de datos

text

Alias
UMLS CUI [1]
C3174092
Route
Descripción

Route

Tipo de datos

text

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

Start Date

Tipo de datos

date

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

End Date

Tipo de datos

date

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

End Date is End Date of Study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0806020
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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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