ID

14928

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: Check for Study Continuation

Keywords

Versions (1)
  1. 5/8/16 5/8/16 -
Uploaded on

May 8, 2016

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Creative Commons BY-NC 3.0
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Check for Study Continuation Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

English

Check for Study Continuation "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
Check for Study Continuation
Description

Check for Study Continuation

Did the subject return for visit 2
Description

Yes, Please complete the next pages No, Please tick the ONE most appropriate reason and skip the following pages of this visit.

Data type

boolean

Alias
UMLS CUI [1]
C2827364
most appropriate reason
Description

If Serious adverse event - Please complete and submit SAE report - Please specify SAE No. If Non-Serious adverse event - Please complete Non-serious Adverse Event section - Please specify AE No. or solicited AE code If Other, please specify (e.g.: consent withdrawal, Protocol violation, ... )

Data type

text

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0392360
Code of SAE,AE or solicited AE
Description

Code of SAE,AE,solicited AE or specification

Data type

text

Alias
UMLS CUI [1]
C0877248
Who made the decision
Description

Who made the decision

Data type

text

Alias
UMLS CUI [1]
C1389424
Laboratory Tests:Blood Sample
Description

Laboratory Tests:Blood Sample

Has a Blood Sample been taken
Description

Blood Sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date of sample
Description

Only fill in if different from visit date

Data type

date

Alias
UMLS CUI [1]
C0460065
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Similar models

Check for Study Continuation "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
Check for Study Continuation
Did the subject return for visit 2
Item
Did the subject return for visit 2
boolean
C2827364 (UMLS CUI [1])
Item
most appropriate reason
text
C0679823 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
most appropriate reason for Absence
Code List
most appropriate reason
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
Code of SAE,AE,solicited AE or specification
Item
Code of SAE,AE or solicited AE
text
C0877248 (UMLS CUI [1])
Item
Who made the decision
text
C1389424 (UMLS CUI [1])
Who made the decision:
Code List
Who made the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Blood Sample
Item
Has a Blood Sample been taken
boolean
C0005834 (UMLS CUI [1])
Date of sample
Item
Date of sample
date
C0460065 (UMLS CUI [1])
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