ID

14924

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: Vaccine administration

Stichworte

Versionen (4)
  1. 08.05.16 08.05.16 -
  2. 08.05.16 08.05.16 -
  3. 08.05.16 08.05.16 -
  4. 08.05.16 08.05.16 -
Hochgeladen am

8. Mai 2016

DOI

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

Englisch

Vaccine Administration "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulare  
Identification
Beschreibung

Identification

Alias
UMLS CUI-1
C1300638
Center number
Beschreibung

Center number

Datentyp

text

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

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Beschreibung

Treatment Number

Datentyp

text

Alias
UMLS CUI [1]
C1522541
Visit Number
Beschreibung

Visit Number

Datentyp

integer

Alias
UMLS CUI [1]
C0545082
Vaccine Administration Meta
Beschreibung

Vaccine Administration Meta

Alias
UMLS CUI-1
C1533734
UMLS CUI-2
C0042196
Vaccine Administratrion Date
Beschreibung

Fill in only if different from visit date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0042196
Pre-Vaccination temperature
Beschreibung

Pre-Vaccination temperature

Datentyp

text

Alias
UMLS CUI [1]
C0039476
Pre-Vaccination Temperature Route of Measurement
Beschreibung

Pre-Vaccination Temperature Route of Measurement

Datentyp

text

Alias
UMLS CUI [1]
C0449444
Vaccine Administration Details: 10Pn-PD-DiT Vaccine OR Prevenar Vaccine
Beschreibung

Vaccine Administration Details: 10Pn-PD-DiT Vaccine OR Prevenar Vaccine

Alias
UMLS CUI-1
C1533734
UMLS CUI-2
C0042196
Vaccine Administration
Beschreibung

please complete not administered below

Datentyp

text

Alias
UMLS CUI [1]
C0042196
Replacement vial Number
Beschreibung

only if vial is replaced

Datentyp

text

Alias
UMLS CUI [1]
C0184301
Wrong vial number
Beschreibung

only fill in if vial number is wrong

Datentyp

text

Alias
UMLS CUI [1]
C0184301
Side / Route Site
Beschreibung

Injection according to Protocol ist right side I.M.

Datentyp

integer

Alias
UMLS CUI [1]
C1515974
Has the study vaccine been administered according to protocol?
Beschreibung

Administration according to Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C1507394
Injection side
Beschreibung

If the study vaccine has not been administered according to protocol

Datentyp

text

Alias
UMLS CUI [1]
C0441987
Injection site
Beschreibung

If the study vaccine has not been administered according to protocol

Datentyp

integer

Alias
UMLS CUI [1]
C1515974
Injection Route
Beschreibung

If the study vaccine has not been administered according to protocol

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Vaccine Administration Details: DTPa-HBV-IPV/Hib Vaccine
Beschreibung

Vaccine Administration Details: DTPa-HBV-IPV/Hib Vaccine

Alias
UMLS CUI-1
C1533734
UMLS CUI-2
C0042196
Vaccine Administration
Beschreibung

please complete not administered below

Datentyp

text

Alias
UMLS CUI [1]
C0042196
Replacement vial Number
Beschreibung

only if vial is replaced

Datentyp

text

Alias
UMLS CUI [1]
C0184301
Wrong vial number
Beschreibung

only fill in if vial number is wrong

Datentyp

text

Alias
UMLS CUI [1]
C0184301
Side / Route Site
Beschreibung

Injection according to Protocol ist right side I.M.

Datentyp

integer

Alias
UMLS CUI [1]
C1515974
Has the study vaccine been administered according to protocol?
Beschreibung

Administration according to Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C1507394
Injection side
Beschreibung

If the study vaccine has not been administered according to protocol

Datentyp

text

Alias
UMLS CUI [1]
C0441987
Injection site
Beschreibung

If the study vaccine has not been administered according to protocol

Datentyp

integer

Alias
UMLS CUI [1]
C1515974
Injection Route
Beschreibung

If the study vaccine has not been administered according to protocol

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Non Administration
Beschreibung

Non Administration

Alias
UMLS CUI-1
C1533734
Why not administered
Beschreibung

Please specify below If SAE: Please complete and submit SAE report If AE: Please complete Non-serious Adverse Event section

Datentyp

text

Alias
UMLS CUI [1]
C1533734
Number of serious adverse event
Beschreibung

SAE No

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Number of non-serious adverse event
Beschreibung

AE No

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Description of other adverse event
Beschreibung

Description of other adverse event

Datentyp

text

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

Who made the decision

Datentyp

text

Alias
UMLS CUI [1]
C1389424
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Ähnliche Modelle

Vaccine Administration "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Vaccine Administration Meta
C1533734 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Vaccine Administratrion Date
Item
Vaccine Administratrion Date
date
C0011008 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
text
C0039476 (UMLS CUI [1])
Item
Pre-Vaccination Temperature Route of Measurement
text
C0449444 (UMLS CUI [1])
Pre-Vaccination Temperature Route of Measurement
Code List
Pre-Vaccination Temperature Route of Measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
CL Item
Tympanic (oral conversion) (X)
CL Item
Tympanic (rectal conversion) (Y)
Item Group
Vaccine Administration Details: 10Pn-PD-DiT Vaccine OR Prevenar Vaccine
C1533734 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Vaccine Administration
text
C0042196 (UMLS CUI [1])
vaccination
Code List
Vaccine Administration
CL Item
10Pn-PD-DiT Vaccine OR Prevenar Vaccine (S)
CL Item
Replacement vial  (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial Number
Item
Replacement vial Number
text
C0184301 (UMLS CUI [1])
Wrong vial number
Item
Wrong vial number
text
C0184301 (UMLS CUI [1])
Item
Side / Route Site
integer
C1515974 (UMLS CUI [1])
Side / Route Site
Code List
Side / Route Site
CL Item
deltoid (1)
CL Item
thigh (3)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C1507394 (UMLS CUI [1])
Item
Injection side
text
C0441987 (UMLS CUI [1])
Injection site
Code List
Injection side
CL Item
Left  (L)
CL Item
Right (R)
Item
Injection site
integer
C1515974 (UMLS CUI [1])
Injection site
Code List
Injection site
CL Item
deltoid (1)
CL Item
thigh (3)
CL Item
buttock (6)
Item
Injection Route
text
C0013153 (UMLS CUI [1])
Injection Route
Code List
Injection Route
CL Item
I.M. (im)
CL Item
S.C. (sc)
Item Group
Vaccine Administration Details: DTPa-HBV-IPV/Hib Vaccine
C1533734 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Vaccine Administration
text
C0042196 (UMLS CUI [1])
vaccination
Code List
Vaccine Administration
CL Item
DTPa-HBV-IPV/Hib Vaccine (S)
CL Item
Replacement vial  (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial Number
Item
Replacement vial Number
text
C0184301 (UMLS CUI [1])
Wrong vial number
Item
Wrong vial number
text
C0184301 (UMLS CUI [1])
Item
Side / Route Site
integer
C1515974 (UMLS CUI [1])
Side / Route Site
Code List
Side / Route Site
CL Item
deltoid (1)
CL Item
thigh (3)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C1507394 (UMLS CUI [1])
Item
Injection side
text
C0441987 (UMLS CUI [1])
Injection site
Code List
Injection side
CL Item
Left  (L)
CL Item
Right (R)
Item
Injection site
integer
C1515974 (UMLS CUI [1])
Injection site
Code List
Injection site
CL Item
deltoid (1)
CL Item
thigh (3)
CL Item
buttock (6)
Item
Injection Route
text
C0013153 (UMLS CUI [1])
Injection Route
Code List
Injection Route
CL Item
I.M. (im)
CL Item
S.C. (sc)
Item Group
Non Administration
C1533734 (UMLS CUI-1)
Item
Why not administered
text
C1533734 (UMLS CUI [1])
Why not administered
Code List
Why not administered
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
SAE No
Item
Number of serious adverse event
text
C1519255 (UMLS CUI [1])
AE No
Item
Number of non-serious adverse event
text
C0877248 (UMLS CUI [1])
Description of other adverse event
Item
Description of other adverse event
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)
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