ID

24846

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. 8/19/17 8/19/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 19, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Hepatitis A Vaccine Tracking Document Long Term Follow-up NCT00291876

English

GSK Hepatitis A Vaccine Tracking Document Long Term Follow-up NCT00291876

1 forms  
Study administration
Description

Study administration

Center
Description

Center

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Long Term Follow-up
Description

Long Term Follow-up

Subject number of previous study
Description

Subject number of previous study

Data type

text

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

Subject initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Description

Date of birth

Data type

date

Measurement units
  • day month year
Alias
UMLS CUI [1]
C0421451
day month year
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

study subject participation subject

Data type

integer

Alias
UMLS CUI [1]
C2348568
If answer is 3., choose
Description

study subject participation status adverse event

Data type

integer

Alias
UMLS CUI [1]
C2348568
please specify
Description

study subject participation status specify

Data type

text

Alias
UMLS CUI [1]
C2348568
Date of contact
Description

Date of contact

Data type

date

Alias
UMLS CUI [1]
C0805839
Investigator
Description

Investigator

Investigator name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Date
Description

Signature date

Data type

date

Alias
UMLS CUI [1]
C0807937
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Similar models

GSK Hepatitis A Vaccine Tracking Document Long Term Follow-up NCT00291876

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study administration
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Long Term Follow-up
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 first name family name
text
C2986440 (UMLS CUI [1])
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])
study subject participation subject
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
1. Subject not eligible (1)
CL Item
2. Subject lost to follow-up or not reached (2)
CL Item
3. Subject eligible but not willing to participate due to: (3)
CL Item
4. Subject eligible and agreed to participate in the (4)
CL Item
long-term follow-up study (5)
Item
If answer is 3., choose
integer
C2348568 (UMLS CUI [1])
study subject participation subject
Code List
If answer is 3., choose
CL Item
adverse events, or serious adverse event: (1)
CL Item
other: (2)
study subject participation status specify
Item
please specify
text
C2348568 (UMLS CUI [1])
Date of contact
Item
Date of contact
date
C0805839 (UMLS CUI [1])
Item Group
Investigator
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Signature date
Item
Date
date
C0807937 (UMLS CUI [1])
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