ID
14945
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: Study Conclusion
Palabras clave
Versiones (2)
- 9/5/16 9/5/16 -
- 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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Study Conclusion "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Study Conclusion "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Descripción
Study Conclusion
Descripción
If yes, select major reason for withdrawal.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2349954
Descripción
If Serious adverse event: --> Please complete and submit SAE report --> Please specify SAE No. If Non-Serious adverse event: --> Please complete Non-serious Adverse Event section --> Please specify AE No. or solicited AE code If Other, please specify:
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Descripción
SAE No
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
AE No or solicited AE No
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0877248
Descripción
in case of Protocol violation specify here
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1709750
Descripción
Other, specification
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2348235
Descripción
Who made the decision
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1389424
Descripción
Date of last contact
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1705415
Descripción
If no, please give details in Adverse Events section.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0012634
Descripción
Investigators Signature
Alias
- UMLS CUI-1
- C1519316
Similar models
Study Conclusion "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
C0805701 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C1705415 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])