ID

24975

Beskrivning

Study ID: 100571 (M138) Clinical Study ID: 100571 Study Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 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 https://clinicaltrials.gov/ct2/show/NCT00291876

Länk

https://clinicaltrials.gov/ct2/show/NCT00291876

Nyckelord

Versioner (1)
  1. 2017-08-23 2017-08-23 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 augusti 2017

DOI

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Creative Commons BY-NC 3.0
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GSK Hepatitis A Vaccine ADDITIONAL VACCINATION STUDY CONCLUSION NCT00291876

Engelsk

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION STUDY CONCLUSION NCT00291876

1 Formulär  
Study administration
Beskrivning

Study administration

Subject Number
Beskrivning

Subject Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
FOLLOW-UP STUDIES
Beskrivning

FOLLOW-UP STUDIES

Would the subject be willing to participate in a follow-up study?
Beskrivning

participation status study subject

Datatyp

integer

Alias
UMLS CUI [1]
C2348568
Adverse Events, or Serious Adverse Events:
Beskrivning

participation status study subject adverse event

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0877248
please specify
Beskrivning

participation status study subject adverse event specify

Datatyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0877248
Other
Beskrivning

participation status study subject other reason

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0566251
please specify:
Beskrivning

participation status study subject specify other reason

Datatyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0566251
PREGNANCY INFORMATION
Beskrivning

PREGNANCY INFORMATION

Has the subject become pregnant during the study?
Beskrivning

pregnancy

Datatyp

integer

Alias
UMLS CUI [1]
C0032961
STUDY CONCLUSION
Beskrivning

STUDY CONCLUSION

Did any elimination criteria become applicable during the study?
Beskrivning

elimination criteria

Datatyp

integer

Alias
UMLS CUI [1]
C0680251
please specify
Beskrivning

specify elimination 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

integer

Alias
UMLS CUI [1]
C2348568
If Non-Serious adverse Event, please specify AE N°:
Beskrivning

drop out NAE

Datatyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0237753
If Protocol violation, please specify:
Beskrivning

drop out protocol violation

Datatyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1709750
If Other, please specify:
Beskrivning

drop out other reason

Datatyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3840932
Date of last contact:
Beskrivning

Date of last contact

Datatyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Beskrivning

subject condition

Datatyp

integer

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
INVESTIGATOR SIGNATURE
Beskrivning

INVESTIGATOR SIGNATURE

Date
Beskrivning

Signature date

Datatyp

date

Alias
UMLS CUI [1]
C0807937
Investigators signature
Beskrivning

signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
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Similar models

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION STUDY CONCLUSION NCT00291876

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Study administration
Subject Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
FOLLOW-UP STUDIES
Item
Would the subject be willing to participate in a follow-up study?
integer
C2348568 (UMLS CUI [1])
participation status study subject
Code List
Would the subject be willing to participate in a follow-up study?
CL Item
Yes (1)
CL Item
No, please specify the reason (2)
participation status study subject adverse event
Item
Adverse Events, or Serious Adverse Events:
boolean
C2348568 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
participation status study subject adverse event specify
Item
please specify
text
C2348568 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
participation status study subject other reason
Item
Other
boolean
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
participation status study subject specify other reason
Item
please specify:
text
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item Group
PREGNANCY INFORMATION
Item
Has the subject become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
pregnancy
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
STUDY CONCLUSION
Item
Did any elimination criteria become applicable during the study?
integer
C0680251 (UMLS CUI [1])
elimination criteria
Code List
Did any elimination criteria become applicable during the study?
CL Item
No (1)
CL Item
Yes, please specify (2)
specify elimination criteria
Item
please specify
text
C0680251 (UMLS CUI [1])
Item
Has the subject dropped out of the study?
integer
C2348568 (UMLS CUI [1])
drop out
Code List
Has the subject dropped out of the study?
CL Item
No (1)
CL Item
Yes, (SAE) Serious adverse event (complete the Serious Adverse Event form). (2)
CL Item
Yes, (AEX) Non-Serious adverse event (complete the Non-serious Adverse Event form). (3)
CL Item
Yes, (PTV) Protocol violation, please specify: (4)
CL Item
Yes, (CWS) Consent withdrawal, not due to an adverse event. (5)
CL Item
Yes, (MIG) Migrated / moved from the study area (6)
CL Item
Yes, (LFU) Lost to follow-up. (7)
CL Item
Yes, (OTH) Other, please specify: (8)
drop out NAE
Item
If Non-Serious adverse Event, please specify AE N°:
text
C2348568 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
drop out protocol violation
Item
If Protocol violation, please specify:
text
C2348568 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
drop out other reason
Item
If Other, please specify:
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Date of last contact
Item
Date of last contact:
date
C0805839 (UMLS CUI [1])
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)
Item Group
INVESTIGATOR SIGNATURE
Signature date
Item
Date
date
C0807937 (UMLS CUI [1])
signature
Item
Investigators signature
text
C1519316 (UMLS CUI [1])
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