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

Keywords

Versions (3)
  1. 5/9/16 5/9/16 -
  2. 5/9/16 5/9/16 -
  3. 5/11/16 5/11/16 -
Uploaded on

May 11, 2016

DOI

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License

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

English

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

1 forms  
Identification
Description

Identification

Alias
UMLS CUI-1
C1300638
Center number
Description

Center number

Data type

text

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

Subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Description

Treatment Number

Data type

text

Alias
UMLS CUI [1]
C1522541
Visit Number
Description

Visit Number

Data type

integer

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

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?
Description

If yes, please complete the following table.

Data type

boolean

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

Non Serious Adverse Events: List

Alias
UMLS CUI-1
C0877248
Number of Adverse Event
Description

AE No.

Data type

boolean

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

Description of Adverse Event

Data type

text

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

Site of Adverse Event

Data type

text

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

Start date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
Stop Date
Description

Stop Date

Data type

date

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

Start during immediate Post Vaccination Period

Data type

boolean

Alias
UMLS CUI [1]
C0205253
Maximum Intensity:
Description

Maximum Intensity:

Data type

integer

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

Relationship to investigational products

Data type

text

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

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Medically attended visit
Description

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

Data type

boolean

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

Medically Attended visit Specification

Data type

text

Alias
UMLS CUI [1]
C0018704
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
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