ID

24845

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 Month 162 VISIT 20 LONG TERM FOLLOW UP NCT00291876

English

GSK Hepatitis A Vaccine Month 162 VISIT 20 LONG TERM FOLLOW UP 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
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
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Similar models

GSK Hepatitis A Vaccine Month 162 VISIT 20 LONG TERM FOLLOW UP 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
INVESTIGATOR SIGNATURE
Signature date
Item
Date
date
C0807937 (UMLS CUI [1])
signature
Item
Investigators signature
text
C1519316 (UMLS CUI [1])
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