ID

15002

Descrizione

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

Keywords

versioni (3)
  1. 09/05/16 09/05/16 -
  2. 09/05/16 09/05/16 -
  3. 11/05/16 11/05/16 -
Caricato su

11 maggio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Non-Serious Adverse Events Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

Inglese

Non-Serious Adverse Events "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 moduli  
Identification
Descrizione

Identification

Alias
UMLS CUI-1
C1300638
Center number
Descrizione

Center number

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0805701
Subject ID
Descrizione

Subject ID

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Descrizione

Treatment Number

Tipo di dati

text

Alias
UMLS CUI [1]
C1522541
Visit Number
Descrizione

Visit Number

Tipo di dati

integer

Alias
UMLS CUI [1]
C0545082
Non Serious Adverse Events
Descrizione

Non Serious Adverse Events

Alias
UMLS CUI-1
C0877248
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Descrizione

If yes, please complete the following table.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0877248
Non Serious Adverse Events: List
Descrizione

Non Serious Adverse Events: List

Alias
UMLS CUI-1
C0877248
Number of Adverse Event
Descrizione

AE No.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0877248
Description of Adverse Event
Descrizione

Description of Adverse Event

Tipo di dati

text

Alias
UMLS CUI [1]
C0877248
Site of Adverse Event
Descrizione

Site of Adverse Event

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1515974
Start date
Descrizione

Start date

Tipo di dati

date

Unità di misura
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
Stop Date
Descrizione

Stop Date

Tipo di dati

date

Alias
UMLS CUI [1]
C0806020
Start during immediate Post Vaccination Period
Descrizione

Start during immediate Post Vaccination Period

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0205253
Maximum Intensity:
Descrizione

Maximum Intensity:

Tipo di dati

integer

Alias
UMLS CUI [1]
C0518690
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrizione

Relationship to investigational products

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
Outcome:
Descrizione

Outcome

Tipo di dati

integer

Alias
UMLS CUI [1]
C1705586
Medically attended visit
Descrizione

(Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: Medical Personnel

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0545082
Medically Attended visit Specification
Descrizione

Medically Attended visit Specification

Tipo di dati

text

Alias
UMLS CUI [1]
C0018704
Ritorna all'inizio della pagina

Similar models

Non-Serious Adverse Events "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Identification
C1300638 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Item
Visit Number
integer
C0545082 (UMLS CUI [1])
Visit Number
Code List
Visit Number
CL Item
1 (1)
CL Item
2 (2)
Item Group
Non Serious Adverse Events
C0877248 (UMLS CUI-1)
Non-Serious Adverse Events occurred
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C0877248 (UMLS CUI [1])
Item Group
Non Serious Adverse Events: List
C0877248 (UMLS CUI-1)
AE No.
Item
Number of Adverse Event
boolean
C0877248 (UMLS CUI [1])
Description of Adverse Event
Item
Description of Adverse Event
text
C0877248 (UMLS CUI [1])
Item
Site of Adverse Event
text
C0877248 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Site of Adverse Event
Code List
Site of Adverse Event
CL Item
Administration sites: 10Pn-PD-DiT vaccineor Prevenar vaccine (L901)
CL Item
Administration sites: DTPa-HBV-IPV/Hib vaccine (L93)
CL Item
Non-administration site (G)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Start during immediate Post Vaccination Period
Item
Start during immediate Post Vaccination Period
boolean
C0205253 (UMLS CUI [1])
Item
Maximum Intensity:
integer
C0518690 (UMLS CUI [1])
Maximum Intensity:
Code List
Maximum Intensity:
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Relationship to investigational products
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
Yes (Y)
CL Item
No (N)
Item
Outcome:
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome:
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1])
Item
Medically Attended visit Specification
text
C0018704 (UMLS CUI [1])
Medically Attended visit Specification
Code List
Medically Attended visit Specification
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial