ID

14945

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: Study Conclusion

Stichworte

Versionen (2)
  1. 09.05.16 09.05.16 -
  2. 11.05.16 11.05.16 -
Hochgeladen am

9. Mai 2016

DOI

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

Englisch

Study Conclusion "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
Study Conclusion
Beschreibung

Study Conclusion

Was the subject withdrawn from the study?
Beschreibung

If yes, select major reason for withdrawal.

Datentyp

boolean

Alias
UMLS CUI [1]
C2349954
Major reason for withdrawal
Beschreibung

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:

Datentyp

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
SAE No
Beschreibung

SAE No

Datentyp

text

Alias
UMLS CUI [1]
C1519255
AE No or solicited AE No
Beschreibung

AE No or solicited AE No

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Violation of Protocol
Beschreibung

in case of Protocol violation specify here

Datentyp

text

Alias
UMLS CUI [1]
C1709750
Other, specification
Beschreibung

Other, specification

Datentyp

text

Alias
UMLS CUI [1]
C2348235
Who made the decision
Beschreibung

Who made the decision

Datentyp

text

Alias
UMLS CUI [1]
C1389424
Date of last contact
Beschreibung

Date of last contact

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Was the subject in good condition at date of last contact
Beschreibung

If no, please give details in Adverse Events section.

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
Investigators Signature
Beschreibung

Investigators Signature

Alias
UMLS CUI-1
C1519316
Date of Signature
Beschreibung

Date of Signature

Datentyp

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0011008
Printed Investigator's name
Beschreibung

Printed Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Study Conclusion "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
Study Conclusion
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C2349954 (UMLS CUI [1])
Item
Major reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Major reason for withdrawal
Code List
Major reason for withdrawal
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Protocol violation, please specify: (PTV)
CL Item
Consent withdrawal, not due to an adverse event. (CWS)
CL Item
Migrated I moved from the study area (MIG)
CL Item
Lost to follow-up. (LFU)
CL Item
Other (OTH)
SAE No
Item
SAE No
text
C1519255 (UMLS CUI [1])
AE No or solicited AE No
Item
AE No or solicited AE No
text
C0877248 (UMLS CUI [1])
Violation of Protocol
Item
Violation of Protocol
text
C1709750 (UMLS CUI [1])
Other, specification
Item
Other, specification
text
C2348235 (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)
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Condition at date of last contact
Item
Was the subject in good condition at date of last contact
boolean
C0012634 (UMLS CUI [1])
Item Group
Investigators Signature
C1519316 (UMLS CUI-1)
Date of Signature
Item
Date of Signature
date
C1519316 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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