ID
14940
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: Medication
Keywords
Versions (2)
- 5/9/16 5/9/16 -
- 5/11/16 5/11/16 -
Uploaded on
May 9, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Medication "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Medication "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
Medication List
Description
Trade / Generic Name
Data type
text
Alias
- UMLS CUI [1]
- C0027365
Description
Medical Indication
Data type
text
Alias
- UMLS CUI [1]
- C2315323
Description
Prophylactic treatment
Data type
boolean
Alias
- UMLS CUI [1]
- C0199176
Description
Total daily dose
Data type
text
Alias
- UMLS CUI [1]
- C3174092
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Start Date
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
End Date
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
End Date is End Date of Study
Data type
boolean
Alias
- UMLS CUI [1]
- C0806020
Similar models
Medication "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
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C0087111 (UMLS CUI [2])