ID

24480

Descrição

Study ID: 100580 Clinical Study ID: 100580 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: Additional Vaccination - Concomitant Vaccinations, Medication, Non Serious Adverse Events

Link

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

Palavras-chave

Versões (1)
  1. 02/08/2017 02/08/2017 -
Transferido a

2 de agosto de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Additional Vaccination 100580

Inglês

Additional Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 1005780

1 Formulários  
Concomitant Vaccination
Descrição

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Subject Number
Descrição

Subject Number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol?
Descrição

vaccine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0042210
Trade/Generic Name
Descrição

Name

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0042210
Administration date
Descrição

Administration date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
Medication
Descrição

Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0087111
Have any of the above mentioned medications/treatments been administered from 30 days pre-vaccination to 30 days after additional vaccination?
Descrição

Medication

Tipo de dados

integer

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0087111
Trade or generic name
Descrição

Medication name

Tipo de dados

text

Alias
UMLS CUI [1]
C2360065
Medical Indication
Descrição

Indication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Medical Indication: Prophylactic?
Descrição

Prophylactic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0199176
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013227
Total daily dose
Descrição

Total daily dose

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Route
Descrição

Administration Route

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Start Date
Descrição

Medication Start Date

Tipo de dados

date

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

Medication End Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication Ongoing: tick box if continuing at end of Visit 22
Descrição

Medication Ongoing

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2826666
Non-serious Adverse Events
Descrição

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C0042210
Subject Number
Descrição

Subject Number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Descrição

(Please report all serious adverse events only on the Serious Adverse Event (SAE) form).

Tipo de dados

integer

Alias
UMLS CUI [1]
C1518404
Adverse Event Number
Descrição

Adverse Event Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Non-serious adverse events: Description
Descrição

Description

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Non-serious adverse events: Description
Descrição

Description

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Start Date
Descrição

Start Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)
Descrição

Start

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0439659
UMLS CUI [1,2]
C1518404
End Date
Descrição

End Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum Intensity
Descrição

Maximum Intensity

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
In your opinion, did the vaccine possibly contribute to this AE?
Descrição

Causality

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0304229C0042210
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Outcome
Descrição

Outcome

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
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Similar models

Additional Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 1005780

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
vaccine
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol?
boolean
C0042210 (UMLS CUI [1])
Name
Item
Trade/Generic Name
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item Group
Medication
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Item
Have any of the above mentioned medications/treatments been administered from 30 days pre-vaccination to 30 days after additional vaccination?
integer
C0013227 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Medication
Code List
Have any of the above mentioned medications/treatments been administered from 30 days pre-vaccination to 30 days after additional vaccination?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Medication name
Item
Trade or generic name
text
C2360065 (UMLS CUI [1])
Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Prophylactic
Item
Medical Indication: Prophylactic?
boolean
C0199176 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Administration Route
Code List
Route
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Medication Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing: tick box if continuing at end of Visit 22
boolean
C2826666 (UMLS CUI [1])
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
integer
C1518404 (UMLS CUI [1])
Withdrawal
Code List
Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
No (1)
CL Item
Yes, please complete the following table (2)
Adverse Event Number
Item
Adverse Event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Non-serious adverse events: Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Non-serious adverse events: Description
integer
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Description
Code List
Non-serious adverse events: Description
CL Item
Administration sites (1)
CL Item
Non-administration site (2)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start
Item
Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)
boolean
C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Modearte (2)
CL Item
Severe (3)
Causality
Item
In your opinion, did the vaccine possibly contribute to this AE?
boolean
C0304229C0042210 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
CL Item
Died (4)
CL Item
Unknown (5)
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