ID

42317

Beskrivning

Study ID: 108708 Clinical Study ID: 108708 Study Title: A phase IIb, controlled, randomized, multicentre, observer blinded study to evaluate the immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 compared to a second dose of FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years previously vaccinated in FLU-LD-002 clinical trial Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00385840 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Influenza Vaccine GSK1247446A Trade Name: FluarixTM Study Indication: Influenza

Nyckelord

  1. 2021-05-29 2021-05-29 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

29 maj 2021

DOI

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Licens

Creative Commons BY 4.0

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Immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 NCT00385840

Visit 1, Day 0 Vaccination: Informed Consent; Demographics; Randomisation

Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Centre Number
Beskrivning

Centre Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Beskrivning

Treatment Number

Datatyp

text

Alias
UMLS CUI [1]
C1522541
Date of vsit
Beskrivning

Date of vsit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Beskrivning

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Beskrivning

I certify that Informed Consent has been obtained prior to any study procedure.

Datatyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Demographics
Beskrivning

Demographics

Alias
UMLS CUI-1
C1704791
Centre Number
Beskrivning

Centre Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Date of Birth
Beskrivning

Date of Birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beskrivning

Gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Randomisation/ Treatment Allocation
Beskrivning

Randomisation/ Treatment Allocation

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C1522541
Record treatment number
Beskrivning

Record treatment number

Datatyp

text

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091

Similar models

Visit 1, Day 0 Vaccination: Informed Consent; Demographics; Randomisation

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Date of vsit
Item
Date of vsit
date
C1320303 (UMLS CUI [1])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item Group
Randomisation/ Treatment Allocation
C0034656 (UMLS CUI-1)
C1522541 (UMLS CUI-2)
Record treatment number
Item
Record treatment number
text
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])

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