ID

14974

Descrição

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: Reason for non participation

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Versões (3)
  1. 09/05/2016 09/05/2016 -
  2. 10/05/2016 10/05/2016 -
  3. 10/05/2016 10/05/2016 - Julian Varghese
Transferido a

10 de maio de 2016

DOI

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Licença

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

Inglês

Reason for non participation Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

1 Formulários  
Identification
Descrição

Identification

Alias
UMLS CUI-1
C1300638
Center number
Descrição

Center number

Tipo de dados

text

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

Subject ID

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Descrição

Treatment Number

Tipo de dados

text

Alias
UMLS CUI [1]
C1522541
Date of birth
Descrição

Date of birth

Tipo de dados

date

Alias
UMLS CUI [1]
C0421451
Gender
Descrição

Gender

Tipo de dados

text

Alias
UMLS CUI [1]
C0079399
Tracking Document Reason for non participation
Descrição

Tracking Document Reason for non participation

Alias
UMLS CUI-1
C0679823
UMLS CUI-2
C3166257
Previous subject number:
Descrição

Subject number

Tipo de dados

text

Alias
UMLS CUI [1]
C1709561
Date of birth
Descrição

Date of birth

Tipo de dados

date

Alias
UMLS CUI [1]
C0421451
Please document reason for non participation
Descrição

Please specify below

Tipo de dados

integer

Alias
UMLS CUI [1]
C3166257
please specify criteria that are not fullfilled
Descrição

Specification of non-eligibility

Tipo de dados

text

Alias
UMLS CUI [1]
C3166257
Subject not willing due to: adverse events, or serious adverse event: please specify:
Descrição

Subject not willing due to: adverse events, or serious adverse event: please specify:

Tipo de dados

text

Alias
UMLS CUI [1]
C0877248
Subject not willing due to other: please specify:
Descrição

Subject not willing due to other: please specify:

Tipo de dados

text

Subject died on:
Descrição

Death date

Tipo de dados

date

Alias
UMLS CUI [1]
C1148348
Number of SAEs
Descrição

Number of SAEs

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
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Similar models

Reason for non participation Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (m)
CL Item
Female (f)
Item Group
Tracking Document Reason for non participation
C0679823 (UMLS CUI-1)
C3166257 (UMLS CUI-2)
Subject number
Item
Previous subject number:
text
C1709561 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Please document reason for non participation
integer
C3166257 (UMLS CUI [1])
Reason for non participation
Code List
Please document reason for non participation
CL Item
Subject not eligible (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate (3)
CL Item
Adverse events, or serious adverse event (4)
CL Item
Other (5)
CL Item
Subject died (6)
Specification of non-eligibility
Item
please specify criteria that are not fullfilled
text
C3166257 (UMLS CUI [1])
Subject not willing due to: adverse events, or serious adverse event: please specify:
Item
Subject not willing due to: adverse events, or serious adverse event: please specify:
text
C0877248 (UMLS CUI [1])
Subject not willing due to other: please specify:
Item
Subject not willing due to other: please specify:
text
Death date
Item
Subject died on:
date
C1148348 (UMLS CUI [1])
Number of SAEs
Item
Number of SAEs
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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