ID

24166

Description

Study ID: 100576 (Y11) Clinical Study ID: 100576 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 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: Tracking Document, Long Term Follow-up

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Versions (1)
  1. 27/07/2017 27/07/2017 -
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27 juillet 2017

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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Serious Long Term Follow-up 100576

Anglais

Long Term Follow-up Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100576

1 Formulaires  
Long Term Follow-up
Description

Long Term Follow-up

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

Subject number of previous study

Type de données

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C2242969
Subject initials
Description

Subject initials

Type de données

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0681850
Date of birth
Description

Date of birth

Type de données

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.
Description

long-term follow-up study participation

Type de données

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:
Description

long-term follow-up study participation

Type de données

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
Description

Subject eligible but not willing to participate due to

Type de données

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
Description

Subject eligible but not willing to participate due to

Type de données

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1517942
UMLS CUI [1,3]
C0170300
Investigator signature
Description

Investigator signature

Type de données

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Description

Investigator signature date

Type de données

date

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

Long Term Follow-up Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100576

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Subject initials
Item
Subject initials
text
C2986440 (UMLS CUI [1,1])
C0681850 (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])
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])
Retour au début de la page 

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