ID
14947
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
Palavras-chave
Versões (3)
- 09/05/2016 09/05/2016 -
- 10/05/2016 10/05/2016 -
- 10/05/2016 10/05/2016 - Julian Varghese
Transferido a
9 de maio de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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TEST StudyReason 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
Descrição
Tracking Document Reason for non participation
Alias
- UMLS CUI-1
- C0679823
- UMLS CUI-2
- C3166257
Descrição
Subject number
Tipo de dados
text
Alias
- UMLS CUI [1]
- C1709561
Descrição
Date of birth
Tipo de dados
date
Alias
- UMLS CUI [1]
- C0421451
Descrição
Please specify below
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C3166257
Descrição
Specification of non-eligibility
Tipo de dados
text
Alias
- UMLS CUI [1]
- C3166257
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)