ID

22997

Descripción

Study ID: 100484 Clinical Study ID: 100484 (DTPa) Study Title: An open prospective study of immunogenicity and reactogenicity of DTPa vaccine (Infanrix) given as a booster to healthy school children 10 to 12 years of age Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed Trade Name: BIO DTPA (INFANRIX); Infanrix Study Indication: Acellular Pertussis; Diphtheria; Tetanus; acellular pertussis Documentation: Study Conclusion

Palabras clave

Versiones (1)
  1. 19/6/17 19/6/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

19 de junio de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Study Conclusion: GSK DTPa vaccine (Infanrix) 100484

Inglés

Study ID: 100484 Study Conclusion

1 formularios  
Study Conclusion
Descripción

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Did the subject experience any Serious Adverse Event during the study period ?
Descripción

Serious Adverse Event

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
Number of SAE's
Descripción

Serious Adverse Event? If Yes, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Did any elimination criteria become applicable during the study?
Descripción

elimination criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
Did any elimination criteria become applicable during the study? If Yes, please specify
Descripción

elimination criteria

Tipo de datos

text

Alias
UMLS CUI [1]
C0680251
Was the subject withdrawn from study?
Descripción

withdrawn

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Descripción

If No, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
SAE Number
Descripción

If Serious adverse event, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE Number or Code
Descripción

If Non-serious adverse event, please specify

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
If Protocol violation, please specify
Descripción

Protocol violation

Tipo de datos

text

Alias
UMLS CUI [1]
C1709750
Other reason for withdrawal
Descripción

If Other, please specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
reason for withdrawal
Descripción

reason for withdrawal

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Date of last contact
Descripción

Date of last contact

Tipo de datos

date

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

subject condition

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Investigators signature
Descripción

Investigators signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Investigators signature Date
Descripción

Investigators signature Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2346576
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Similar models

Study ID: 100484 Study Conclusion

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
Number of SAEs
Item
Number of SAE's
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
elimination criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
elimination criteria
Item
Did any elimination criteria become applicable during the study? If Yes, please specify
text
C0680251 (UMLS CUI [1])
Item
Was the subject withdrawn from study?
integer
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
subject come at visit 2
Code List
Was the subject withdrawn from study?
CL Item
No (1)
CL Item
Yes, Please tick the ONE most appropriate category for drop out. (2)
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for study discontinuation
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Protocol violation (3)
CL Item
Consent withdrawal, not due to an adverse event. (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number or Code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Protocol violation
Item
If Protocol violation, please specify
text
C1709750 (UMLS CUI [1])
Other reason for withdrawal
Item
Other reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for withdrawal
integer
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for study discontinuation
Code List
reason for withdrawal
CL Item
Investigator’s decision (1)
CL Item
Subject’s decision (2)
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item
Was the subject in good condition at date of last contact?
integer
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
subject condition
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section (1)
CL Item
Yes (2)
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Investigators signature Date
Item
Investigators signature Date
date
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
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