ID
15002
Beschreibung
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
Stichworte
Versionen (3)
- 09.05.16 09.05.16 -
- 09.05.16 09.05.16 -
- 11.05.16 11.05.16 -
Hochgeladen am
11. Mai 2016
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
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
Beschreibung
Non Serious Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beschreibung
Non Serious Adverse Events: List
Alias
- UMLS CUI-1
- C0877248
Beschreibung
AE No.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Description of Adverse Event
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Site of Adverse Event
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1515974
Beschreibung
Start date
Datentyp
date
Maßeinheiten
- dd/mm/yy
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
Stop Date
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Start during immediate Post Vaccination Period
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0205253
Beschreibung
Maximum Intensity:
Datentyp
integer
Alias
- UMLS CUI [1]
- C0518690
Beschreibung
Relationship to investigational products
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C0877248
Beschreibung
Outcome
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
(Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: Medical Personnel
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0545082
Beschreibung
Medically Attended visit Specification
Datentyp
text
Alias
- UMLS CUI [1]
- C0018704
Ähnliche Modelle
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])