ID
14974
Description
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
Keywords
Versions (3)
- 5/9/16 5/9/16 -
- 5/10/16 5/10/16 -
- 5/10/16 5/10/16 - Julian Varghese
Uploaded on
May 10, 2016
DOI
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License
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
Reason for non participation Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396
Description
Tracking Document Reason for non participation
Alias
- UMLS CUI-1
- C0679823
- UMLS CUI-2
- C3166257
Description
Subject number
Data type
text
Alias
- UMLS CUI [1]
- C1709561
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Please specify below
Data type
integer
Alias
- UMLS CUI [1]
- C3166257
Description
Specification of non-eligibility
Data type
text
Alias
- UMLS CUI [1]
- C3166257
Description
Subject not willing due to: adverse events, or serious adverse event: please specify:
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Subject not willing due to other: please specify:
Data type
text
Description
Death date
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
Number of SAEs
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Similar models
Reason for non participation Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396
C0805701 (UMLS CUI [1,2])
C3166257 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])