ID

33874

Beschrijving

Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Trefwoorden

Versies (1)
  1. 05-01-19 05-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

5 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B

Engels

Study Conclusion

1 Formulieren  
  1. StudyEvent: ODM
    1. Study Conclusion
Study Conclusion
Beschrijving

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Has the subject become pregnant during the study?
Beschrijving

Pregnant During the Study

Datatype

text

Alias
UMLS CUI [1]
C3828490
Has the code been broken?
Beschrijving

Clinical Research, Code

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0805701
Did any elimination criteria become applicable during the study?
Beschrijving

Exclusion Criteria, Applicable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1706839
Has the subject dropped out of the study? (a drop out is a subject who did not come back for the concluding visit foreseen in the protocol.)
Beschrijving

Study Subject Participation Status, Withdrawal by Subject

Datatype

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1710677
Date of last contact
Beschrijving

Withdraw, Date last contact

Datatype

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0805839
Was the subject in good condition at date of last contact?
Beschrijving

Withdraw, Date last contact, Condition

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0805839
UMLS CUI [1,3]
C1142435
Investigator Signature
Beschrijving

Investigator Signature

Alias
UMLS CUI-1
C2346576
Date
Beschrijving

I certify that I have reviewed the data in this case report form, the Adverse Events and Serious Adverse Event sections including any laboratory data (if appropriate) and that all information is complete and accurate.

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator Signature
Beschrijving

Investigator Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Study Conclusion

1 Formulieren
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Has the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Pregnant During the Study
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)
Clinical Research, Code
Item
Has the code been broken?
boolean
C0008972 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Exclusion Criteria, Applicable
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
Item
Has the subject dropped out of the study? (a drop out is a subject who did not come back for the concluding visit foreseen in the protocol.)
text
C2348568 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])
Study Subject Participation Status, Withdrawal by Subject
Code List
Has the subject dropped out of the study? (a drop out is a subject who did not come back for the concluding visit foreseen in the protocol.)
CL Item
No (1)
CL Item
Yes, Serious adverse event (complete the Serious Adverse Event form) (SAE) (2)
CL Item
Yes, Non-serious adverse event, (complete the Non-Serious Adverse Events section), (3)
CL Item
please specify AE No. (AEX) (please specify AE No. (AEX))
CL Item
Yes, Protocol violation, please specify (PTV) (4)
CL Item
Yes, Consent withdrawal, not due to an adverse event (CWS) (5)
CL Item
Yes, ™Migrated / moved from the study area (MIG) (6)
CL Item
Yes, ™Lost to follow-up (LFU) (7)
CL Item
Yes, Others, please specify (OTH) (8)
Withdraw, Date last contact
Item
Date of last contact
date
C2349954 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Item
Was the subject in good condition at date of last contact?
text
C2349954 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
Withdraw, Date last contact, Condition
Code List
Was the subject in good condition at date of last contact?
CL Item
Yes (2)
CL Item
No, please give details within the Adverse Events section ™  (™1)
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
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