ID

24479

Descrizione

Study ID: 100579 Clinical Study ID: 100579 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

collegamento

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

Keywords

versioni (1)
  1. 02/08/17 02/08/17 -
Caricato su

2 agosto 2017

DOI

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Licenza

Creative Commons BY-NC 3.0
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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Study Conclusion 100579

Inglese

Study Conclusion Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100579

1 moduli  
Follow-up Studies
Descrizione

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?
Descrizione

follow-up study

Tipo di dati

boolean

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

If No, please specify the reason

Tipo di dati

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
Descrizione

reason for non participation

Tipo di dati

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
Descrizione

reason for non participation

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Investigator Signature
Descrizione

I certify that I have reviewed the data in this case report form, and the Serious Adverse Event section (if applicable) and that all information is complete and accurate.

Tipo di dati

text

Alias
UMLS CUI [1]
C2346576
Long Term Follow-up
Descrizione

Long Term Follow-up

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

Subject number of previous study

Tipo di dati

text

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

Date of birth

Tipo di dati

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.
Descrizione

long-term follow-up study participation

Tipo di dati

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:
Descrizione

long-term follow-up study participation

Tipo di dati

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
Descrizione

Subject eligible but not willing to participate due to

Tipo di dati

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
Descrizione

Subject eligible but not willing to participate due to

Tipo di dati

text

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

Date of contact

Tipo di dati

date

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

Investigator signature

Tipo di dati

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Descrizione

Investigator signature date

Tipo di dati

date

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

Study Conclusion Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100579

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
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])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
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])
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