ID
14928
Beschrijving
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: Check for Study Continuation
Trefwoorden
Versies (1)
- 08-05-16 08-05-16 -
Geüploaded op
8 mei 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Check for Study Continuation Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396
Check for Study Continuation "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Beschrijving
Check for Study Continuation
Beschrijving
Yes, Please complete the next pages No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
Datatype
boolean
Alias
- UMLS CUI [1]
- C2827364
Beschrijving
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 (e.g.: consent withdrawal, Protocol violation, ... )
Datatype
text
Alias
- UMLS CUI [1,1]
- C0679823
- UMLS CUI [1,2]
- C0392360
Beschrijving
Code of SAE,AE,solicited AE or specification
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Who made the decision
Datatype
text
Alias
- UMLS CUI [1]
- C1389424
Beschrijving
Laboratory Tests:Blood Sample
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Check for Study Continuation "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
C0805701 (UMLS CUI [1,2])
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