ID

24482

Beskrivning

Study ID: 100580 Clinical Study ID: 100580 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 https://clinicaltrials.gov/ct2/show/NCT00289757 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A Documentation part: Study Conclusion

Länk

https://clinicaltrials.gov/ct2/show/NCT00289757

Nyckelord

Versioner (1)
  1. 2017-08-02 2017-08-02 -
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2 augusti 2017

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Creative Commons BY-NC 3.0
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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Study Conclusion 100580

Engelsk

Study Conclusion Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100580

1 Formulär  
Long Term Follow-up
Beskrivning

Long Term Follow-up

Alias
UMLS CUI-1
C1517942
UMLS CUI-2
C0170300
Subject number of previous study
Beskrivning

Subject number of previous study

Datatyp

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C2242969
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
Beskrivning

long-term follow-up study participation

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C0170300
Subject eligible but not willing to participate due to:
Beskrivning

long-term follow-up study participation

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C0170300
If adverse events, or serious adverse event, please specify
Beskrivning

Subject eligible but not willing to participate due to

Datatyp

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1517942
UMLS CUI [2,3]
C0170300
If Other, please specify
Beskrivning

Subject eligible but not willing to participate due to

Datatyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C0170300
Date of contact
Beskrivning

Date of contact

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Investigator signature
Beskrivning

Investigator signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Beskrivning

Investigator signature date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Pregnancy Information
Beskrivning

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Has the subject become pregnant during the study?
Beskrivning

pregnant

Datatyp

integer

Alias
UMLS CUI [1]
C0032961
Follow-up Studies
Beskrivning

Follow-up Studies

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0016441
UMLS CUI-4
C0170300
Would the subject be willing to participate in a follow-up study?
Beskrivning

follow-up study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
reason for non participation
Beskrivning

If No, please specify the reason

Datatyp

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Reason for non participation: Adverse Events, or Serious Adverse Events, please specify
Beskrivning

reason for non participation

Datatyp

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2,1]
C0558080
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C0392360
Reason for non participation: Other, please specify
Beskrivning

reason for non participation

Datatyp

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Did any elimination criteria become applicable during the study?
Beskrivning

exclusion criteria

Datatyp

boolean

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

exclusion criteria

Datatyp

text

Alias
UMLS CUI [1]
C0680251
Has the subject dropped out of the study?
Beskrivning

(a drop out is a subject who did not come back for the concluding visit foreseen in the protocol.)

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Has the subject dropped out of the study? If Yes, please mark the ONE most appropriate category for drop out.
Beskrivning

reason for study drop out

Datatyp

integer

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C2348568
If Non-Serious adverse event, Please specify AE Number
Beskrivning

Has the subject dropped out of the study?

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C1444662
UMLS CUI [2,2]
C0392360
If Protocol violation, please specify
Beskrivning

Has the subject dropped out of the study?

Datatyp

text

Alias
UMLS CUI [1]
C1709750
UMLS CUI [2,1]
C1444662
UMLS CUI [2,2]
C0392360
If Other, please specify
Beskrivning

Has the subject dropped out of the study?

Datatyp

text

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C2348568
Date of last contact
Beskrivning

Date of last contact

Datatyp

date

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

subject condition

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
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Similar models

Study Conclusion Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100580

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Long Term Follow-up
C1517942 (UMLS CUI-1)
C0170300 (UMLS CUI-2)
Subject number of previous study
Item
Subject number of previous study
text
C2348585 (UMLS CUI [1,1])
C2242969 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
integer
C2348568 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C0170300 (UMLS CUI [1,3])
long-term follow-up study participation
Code List
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
CL Item
Subject not eligible (1)
CL Item
Subject lost to follow-up or not reached  (2)
CL Item
Subject eligible but not willing to participate due to: (3)
CL Item
Subject eligible and agreed to participate in the long-term follow-up study (4)
Item
Subject eligible but not willing to participate due to:
integer
C2348568 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C0170300 (UMLS CUI [1,3])
undefined item
Code List
Subject eligible but not willing to participate due to:
CL Item
adverse events, or serious adverse event (1)
CL Item
Other (2)
long-term follow-up study participation
Item
If adverse events, or serious adverse event, please specify
text
C0877248 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C1517942 (UMLS CUI [2,2])
C0170300 (UMLS CUI [2,3])
long-term follow-up study participation
Item
If Other, please specify
text
C2348568 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C0170300 (UMLS CUI [1,3])
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Investigator signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Has the subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
pregnant
Code List
Has the subject become pregnant during the study?
CL Item
No (1)
CL Item
Yes, please complete the Pregnancy Report Form.  (2)
CL Item
NA (3)
Item Group
Follow-up Studies
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0016441 (UMLS CUI-3)
C0170300 (UMLS CUI-4)
follow-up study
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for non participation
Code List
reason for non participation
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
reason for non participation
Item
Reason for non participation: Adverse Events, or Serious Adverse Events, please specify
text
C0877248 (UMLS CUI [1])
C0558080 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
reason for non participation
Item
Reason for non participation: Other, please specify
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
exclusion criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
exclusion criteria
Item
Did any elimination criteria become applicable during the study? If Yes, please specify
text
C0680251 (UMLS CUI [1])
study drop out
Item
Has the subject dropped out of the study?
boolean
C2348568 (UMLS CUI [1])
Item
Has the subject dropped out of the study? If Yes, please mark the ONE most appropriate category for drop out.
integer
C1444662 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
reason for study drop out
Code List
Has the subject dropped out of the study? If Yes, please mark the ONE most appropriate category for drop out.
CL Item
Serious adverse event (complete the Serious Adverse Event form).  (1)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event form).  (2)
CL Item
Protocol violation, please specify (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, please specify (7)
AE Number
Item
If Non-Serious adverse event, Please specify AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1444662 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
Protocol violation,
Item
If Protocol violation, please specify
text
C1709750 (UMLS CUI [1])
C1444662 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
reason for study drop out
Item
If Other, please specify
text
C1444662 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Date of last contact
Item
Date of last contact
date
C1705415 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
subject condition
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
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