ID
15002
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: Non-Serious Adverse Events
Mots-clés
Versions (3)
- 09/05/2016 09/05/2016 -
- 09/05/2016 09/05/2016 -
- 11/05/2016 11/05/2016 -
Téléchargé le
11 mai 2016
DOI
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Licence
Creative Commons BY-NC 3.0
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Non-Serious Adverse Events Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396
Non-Serious Adverse Events "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Description
Non Serious Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
Non Serious Adverse Events: List
Alias
- UMLS CUI-1
- C0877248
Description
AE No.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0877248
Description
Description of Adverse Event
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
Site of Adverse Event
Type de données
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1515974
Description
Start date
Type de données
date
Unités de mesure
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0808070
Description
Stop Date
Type de données
date
Alias
- UMLS CUI [1]
- C0806020
Description
Start during immediate Post Vaccination Period
Type de données
boolean
Alias
- UMLS CUI [1]
- C0205253
Description
Maximum Intensity:
Type de données
integer
Alias
- UMLS CUI [1]
- C0518690
Description
Relationship to investigational products
Type de données
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C0877248
Description
Outcome
Type de données
integer
Alias
- UMLS CUI [1]
- C1705586
Description
(Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: Medical Personnel
Type de données
boolean
Alias
- UMLS CUI [1]
- C0545082
Description
Medically Attended visit Specification
Type de données
text
Alias
- UMLS CUI [1]
- C0018704
Similar models
Non-Serious Adverse Events "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
C0805701 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])