ID

42317

Descripción

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

Palabras clave

  1. 29/5/21 29/5/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

29 de mayo de 2021

DOI

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Licencia

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
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Centre Number
Descripción

Centre Number

Tipo de datos

text

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

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Descripción

Treatment Number

Tipo de datos

text

Alias
UMLS CUI [1]
C1522541
Date of vsit
Descripción

Date of vsit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Descripción

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Descripción

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

Tipo de datos

date

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

Demographics

Alias
UMLS CUI-1
C1704791
Centre Number
Descripción

Centre Number

Tipo de datos

text

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

Date of Birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

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

Randomisation/ Treatment Allocation

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

Record treatment number

Tipo de datos

text

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

Similar models

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

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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