ID

35177

Descrição

Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of his form is to to collect the subject's demographic data. Subject number will be the same as in the previous study. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1 Visit 1 and 2 are part of the study: "Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373" LONG-TERM FOLLOW-UP PREVIOUS STUDY 107022 (FLU-LD-001) Subject number will be the same as in the previous study.

Link

https://clinicaltrials.gov/ct2/show/NCT00321373

Palavras-chave

  1. 13/02/2019 13/02/2019 -
  2. 22/02/2019 22/02/2019 -
  3. 25/02/2019 25/02/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

22 de fevereiro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0

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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix EudraCT Number 2006-000939-97

Demographics

  1. StudyEvent: ODM
    1. Demographics
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit
Descrição

Date of Visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Treatment Number
Descrição

Treatment Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Demographics
Descrição

Demographics

Alias
UMLS CUI-1
C1704791
Center Number
Descrição

Center Number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Descrição

Date of Birth

Tipo de dados

date

Alias
UMLS CUI [1]
C0421451
Gender
Descrição

Gender

Tipo de dados

text

Alias
UMLS CUI [1]
C0079399

Similar models

Demographics

  1. StudyEvent: ODM
    1. Demographics
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
integer
C2348585 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (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)

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