ID

24973

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. 8/23/17 8/23/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 23, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Hepatitis A Vaccine ADDITIONAL VACCINATION SAE continued NCT00291876

English

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION SAE continued NCT00291876

1 forms  
Study administration
Description

Study administration

Subject Number
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Study vaccine Information
Description

Study vaccine Information

Vaccine
Description

(specify mixed or separate)

Data type

text

Alias
UMLS CUI [1]
C0042210
Dose No
Description

Dose Number

Data type

integer

Alias
UMLS CUI [1,1]
C1115464
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1519255
Lot No
Description

Lot Number

Data type

integer

Alias
UMLS CUI [1,1]
C2826710
UMLS CUI [1,2]
C0042210
Route / Site
Description

Administration Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Date
Description

administration date

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
Concomitant medication / vaccination that could have contributed to this SAE
Description

Concomitant medication / vaccination that could have contributed to this SAE

Drug / vaccine
Description

concomitant medication

Data type

text

Alias
UMLS CUI [1]
C2347852
Dosage
Description

Dosage

Data type

text

Alias
UMLS CUI [1]
C0178602
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date
Description

concomitant medication start date

Data type

date

Alias
UMLS CUI [1]
C2826734
End Date
Description

concomitant medication end date

Data type

date

Alias
UMLS CUI [1]
C2826744
Relevant intercurrent illness & medical history that could have contributed to this SAE
Description

Relevant intercurrent illness & medical history that could have contributed to this SAE

Condition
Description

Condition

Data type

text

Alias
UMLS CUI [1]
C0012634
Still present?
Description

Condition still present

Data type

boolean

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1519255
Drug(s) used to treat this SAE
Description

Drug(s) used to treat this SAE

Drug
Description

Drug

Data type

text

Alias
UMLS CUI [1]
C0013227
Dosage
Description

Dosage

Data type

text

Alias
UMLS CUI [1]
C0178602
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Start date
Description

drug start date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Description

drug end date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Surgical treatment for this SAE
Description

Surgical treatment for this SAE

Surgical treatment for this SAE, please specify
Description

Surgical treatment

Data type

text

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1519255
Description
Description

Description

Description (provide a brief narrative description of the SAE including relevant diagnostic findings, lab data & evolution of the events etc…)
Description

Description

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
AEGIS number
Description

AEGIS number

Data type

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0600091
Comments
Description

Comments

Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

GSK Hepatitis A Vaccine ADDITIONAL VACCINATION SAE continued 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
Study vaccine Information
Vaccine
Item
Vaccine
text
C0042210 (UMLS CUI [1])
Dose Number
Item
Dose No
integer
C1115464 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Lot Number
Item
Lot No
integer
C2826710 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration Route
Item
Route / Site
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
administration date
Item
Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item Group
Concomitant medication / vaccination that could have contributed to this SAE
concomitant medication
Item
Drug / vaccine
text
C2347852 (UMLS CUI [1])
Dosage
Item
Dosage
text
C0178602 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
concomitant medication start date
Item
Start Date
date
C2826734 (UMLS CUI [1])
concomitant medication end date
Item
End Date
date
C2826744 (UMLS CUI [1])
Item Group
Relevant intercurrent illness & medical history that could have contributed to this SAE
Condition
Item
Condition
text
C0012634 (UMLS CUI [1])
Condition still present
Item
Still present?
boolean
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
Drug(s) used to treat this SAE
Drug
Item
Drug
text
C0013227 (UMLS CUI [1])
Dosage
Item
Dosage
text
C0178602 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
drug start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
drug end date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Surgical treatment for this SAE
Surgical treatment
Item
Surgical treatment for this SAE, please specify
text
C0543467 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Description
Description
Item
Description (provide a brief narrative description of the SAE including relevant diagnostic findings, lab data & evolution of the events etc…)
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AEGIS number
Item
AEGIS number
text
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Comments
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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