ID

26119

Beschreibung

Study ID: 111028 Clinical Study ID: 111028 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: Concomitant Vaccination

Link

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

Stichworte

Versionen (1)
  1. 09.10.17 09.10.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. Oktober 2017

DOI

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Creative Commons BY-NC 3.0
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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Concomitant Vaccination 111028

Englisch

Concomitant Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111028

1 Formulare  
Concomitant Vaccination
Beschreibung

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
UMLS CUI-3
C0700881
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol? [minimum 30 days] after it?
Beschreibung

Concomitant Vaccination

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Trade / (Generic) Name
Beschreibung

Trade Name

Datentyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0042196
Administration date
Beschreibung

Administration date

Datentyp

date

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

Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0087111
UMLS CUI-3
C0042196
Have any of the above mentioned medications/treatments been administered from 30 days pre-vaccination to 30 days after additional vaccination?
Beschreibung

treatments

Datentyp

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0087111
Trade / Generic name
Beschreibung

Trade name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Medical Indication
Beschreibung

Medical Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Prophylactic
Beschreibung

Prophylactic

Datentyp

boolean

Alias
UMLS CUI [1]
C0199176
Total daily dose
Beschreibung

Total daily dose

Datentyp

float

Alias
UMLS CUI [1]
C2348070
Route
Beschreibung

Administration Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Start date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Beschreibung

End date

Datentyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuing at the end of study?
Beschreibung

Continuing Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C0013227
Non-serious Adverse Events
Beschreibung

Non-serious Adverse Events

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

Subject Number

Datentyp

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?
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Adverse Event Number
Beschreibung

Adverse Event Number

Datentyp

integer

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

Description

Datentyp

text

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

Description

Datentyp

integer

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

Start Date

Datentyp

date

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

Start

Datentyp

boolean

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

End Date

Datentyp

date

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

Maximum Intensity

Datentyp

integer

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

Causality

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0085978
UMLS CUI [1,4]
C1518404
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
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Ähnliche Modelle

Concomitant Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111028

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol? [minimum 30 days] after it?
integer
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
pharmaceutical preparations
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol? [minimum 30 days] after it?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and / or generic (2)
CL Item
name, and vaccine administration date. (3)
Trade Name
Item
Trade / (Generic) Name
text
C2360065 (UMLS CUI [1,1])
C0042196 (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)
C0042196 (UMLS CUI-3)
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 [1,1])
C0087111 (UMLS CUI [1,2])
treatments
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)
Trade name
Item
Trade / Generic name
text
C2360065 (UMLS CUI [1])
Medical Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Prophylactic
Item
Prophylactic
boolean
C0199176 (UMLS CUI [1])
Total daily dose
Item
Total daily dose
float
C2348070 (UMLS CUI [1])
Administration Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Continuing Therapy
Item
Continuing at the end of study?
boolean
C1553904 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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
C1518404 (UMLS CUI [1,1])
C0808070 (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
C1518404 (UMLS CUI [1,1])
C0806020 (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
C0304229 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
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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