ID

24975

Description

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

Link

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

Keywords

Versions (1)
  1. 8/23/17 8/23/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 23, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION STUDY CONCLUSION NCT00291876

English

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION STUDY CONCLUSION NCT00291876

1 forms  
Study administration
Description

Study administration

Subject Number
Description

Subject Identifier

Data type

integer

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

FOLLOW-UP STUDIES

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

participation status study subject

Data type

integer

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

participation status study subject adverse event

Data type

boolean

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

participation status study subject adverse event specify

Data type

text

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

participation status study subject other reason

Data type

boolean

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

participation status study subject specify other reason

Data type

text

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

PREGNANCY INFORMATION

Has the subject become pregnant during the study?
Description

pregnancy

Data type

integer

Alias
UMLS CUI [1]
C0032961
STUDY CONCLUSION
Description

STUDY CONCLUSION

Did any elimination criteria become applicable during the study?
Description

elimination criteria

Data type

integer

Alias
UMLS CUI [1]
C0680251
please specify
Description

specify elimination criteria

Data type

text

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

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

Data type

integer

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

drop out NAE

Data type

text

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

drop out protocol violation

Data type

text

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

drop out other reason

Data type

text

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

Date of last contact

Data type

date

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

subject condition

Data type

integer

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

INVESTIGATOR SIGNATURE

Date
Description

Signature date

Data type

date

Alias
UMLS CUI [1]
C0807937
Investigators signature
Description

signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Back to the top of the page

Similar models

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION STUDY CONCLUSION NCT00291876

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial