ID
14924
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: Vaccine administration
Keywords
Versions (4)
- 5/8/16 5/8/16 -
- 5/8/16 5/8/16 -
- 5/8/16 5/8/16 -
- 5/8/16 5/8/16 -
Uploaded on
May 8, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Vaccine Administration Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396
Vaccine Administration "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Description
Vaccine Administration Meta
Alias
- UMLS CUI-1
- C1533734
- UMLS CUI-2
- C0042196
Description
Fill in only if different from visit date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1533734
- UMLS CUI [1,3]
- C0042196
Description
Pre-Vaccination temperature
Data type
text
Alias
- UMLS CUI [1]
- C0039476
Description
Pre-Vaccination Temperature Route of Measurement
Data type
text
Alias
- UMLS CUI [1]
- C0449444
Description
Vaccine Administration Details: 10Pn-PD-DiT Vaccine OR Prevenar Vaccine
Alias
- UMLS CUI-1
- C1533734
- UMLS CUI-2
- C0042196
Description
please complete not administered below
Data type
text
Alias
- UMLS CUI [1]
- C0042196
Description
only if vial is replaced
Data type
text
Alias
- UMLS CUI [1]
- C0184301
Description
only fill in if vial number is wrong
Data type
text
Alias
- UMLS CUI [1]
- C0184301
Description
Injection according to Protocol ist right side I.M.
Data type
integer
Alias
- UMLS CUI [1]
- C1515974
Description
Administration according to Protocol
Data type
boolean
Alias
- UMLS CUI [1]
- C1507394
Description
If the study vaccine has not been administered according to protocol
Data type
text
Alias
- UMLS CUI [1]
- C0441987
Description
If the study vaccine has not been administered according to protocol
Data type
integer
Alias
- UMLS CUI [1]
- C1515974
Description
If the study vaccine has not been administered according to protocol
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Vaccine Administration Details: DTPa-HBV-IPV/Hib Vaccine
Alias
- UMLS CUI-1
- C1533734
- UMLS CUI-2
- C0042196
Description
please complete not administered below
Data type
text
Alias
- UMLS CUI [1]
- C0042196
Description
only if vial is replaced
Data type
text
Alias
- UMLS CUI [1]
- C0184301
Description
only fill in if vial number is wrong
Data type
text
Alias
- UMLS CUI [1]
- C0184301
Description
Injection according to Protocol ist right side I.M.
Data type
integer
Alias
- UMLS CUI [1]
- C1515974
Description
Administration according to Protocol
Data type
boolean
Alias
- UMLS CUI [1]
- C1507394
Description
If the study vaccine has not been administered according to protocol
Data type
text
Alias
- UMLS CUI [1]
- C0441987
Description
If the study vaccine has not been administered according to protocol
Data type
integer
Alias
- UMLS CUI [1]
- C1515974
Description
If the study vaccine has not been administered according to protocol
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Non Administration
Alias
- UMLS CUI-1
- C1533734
Description
Please specify below If SAE: Please complete and submit SAE report If AE: Please complete Non-serious Adverse Event section
Data type
text
Alias
- UMLS CUI [1]
- C1533734
Description
SAE No
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
AE No
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Description of other adverse event
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Who made the decision
Data type
text
Alias
- UMLS CUI [1]
- C1389424
Similar models
Vaccine Administration "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
C0805701 (UMLS CUI [1,2])
C0042196 (UMLS CUI-2)
C1533734 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI-2)