ID

15004

Beschrijving

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: EXTENDED SAFETY FOLLOW-UP CONTACT

Trefwoorden

Versies (2)
  1. 09-05-16 09-05-16 -
  2. 11-05-16 11-05-16 -
Geüploaded op

11 mei 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Extended safety follow-up contact Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

Engels

Extended safety follow-up contact "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulieren  
Identification
Beschrijving

Identification

Alias
UMLS CUI-1
C1300638
Center number
Beschrijving

Center number

Datatype

text

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

Subject ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Beschrijving

Treatment Number

Datatype

text

Alias
UMLS CUI [1]
C1522541
Date of birth
Beschrijving

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschrijving

Gender

Datatype

text

Alias
UMLS CUI [1]
C0079399
Study Conclusion Extended Safety Follow-Up Contact
Beschrijving

Study Conclusion Extended Safety Follow-Up Contact

Could the subject I subject's parents/guardians be contacted after the end of the active phase?
Beschrijving

Contract after active Phase

Datatype

boolean

Alias
UMLS CUI [1]
C0332522
Date of last contact
Beschrijving

Date of last contact

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Has the subject received any other investigational and/or non-registered vaccine and/or drug since the end of the active phase?
Beschrijving

If yes: GlaxoSmithKline might contact you for further investigation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0949266
Reason for no successive Contract
Beschrijving

Reason for no successive Contract

Datatype

text

Alias
UMLS CUI [1]
C0332522
Did the subject experience any serious adverse event(s) (SAE(s) since the end of the active phase?
Beschrijving

If yes,please complete the complete Serious Adverse Event (SAE) report.

Datatype

text

Alias
UMLS CUI [1]
C1519255
Has the subject experienced any meningitis ?
Beschrijving

Meningitis

Datatype

boolean

Alias
UMLS CUI [1]
C0025289
Investigator's Signature
Beschrijving

Investigator's Signature

Alias
UMLS CUI-1
C1519316
UMLS CUI-2
C2826892
Date of Signature
Beschrijving

Date of Signature

Datatype

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0011008
Name of Investigator
Beschrijving

Name of Investigator

Datatype

text

Alias
UMLS CUI [1]
C0008961
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Similar models

Extended safety follow-up contact "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (m)
CL Item
Female (f)
Item Group
Study Conclusion Extended Safety Follow-Up Contact
Contract after active Phase
Item
Could the subject I subject's parents/guardians be contacted after the end of the active phase?
boolean
C0332522 (UMLS CUI [1])
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Other investigational Vaccines after end of Study
Item
Has the subject received any other investigational and/or non-registered vaccine and/or drug since the end of the active phase?
boolean
C0042210 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
Item
Reason for no successive Contract
text
C0332522 (UMLS CUI [1])
Reason for no successive Contract
Code List
Reason for no successive Contract
CL Item
Consent withdrawal (CWS)
CL Item
Lost to follow-up (LFU)
Item
Did the subject experience any serious adverse event(s) (SAE(s) since the end of the active phase?
text
C1519255 (UMLS CUI [1])
SAE after active phase
Code List
Did the subject experience any serious adverse event(s) (SAE(s) since the end of the active phase?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Subject could not be contacted (NA)
Meningitis
Item
Has the subject experienced any meningitis ?
boolean
C0025289 (UMLS CUI [1])
Item Group
Investigator's Signature
C1519316 (UMLS CUI-1)
C2826892 (UMLS CUI-2)
Date of Signature
Item
Date of Signature
date
C1519316 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])
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