ID
34804
Beskrivning
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 document if informed consent has been obtained and to collect the subjects demographic data. 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
Länk
https://clinicaltrials.gov/ct2/show/NCT00321373
Nyckelord
Versioner (2)
- 2019-01-29 2019-01-29 -
- 2019-02-01 2019-02-01 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
29 januari 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373
Informed Consent and Demographics
- StudyEvent: ODM
Beskrivning
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Beskrivning
I certify that Informed Consent has been obtained prior to any study procedure.
Datatyp
date
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Blood Sample Usage for Further Research
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0008972
- UMLS CUI [2,1]
- C0021403
- UMLS CUI [2,2]
- C0008972
- UMLS CUI [3,1]
- C0021400
- UMLS CUI [3,2]
- C0008972
Beskrivning
Demographics
Alias
- UMLS CUI-1
- C1704791
Beskrivning
Center Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beskrivning
Date of Birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Gender
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Ethnicity
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beskrivning
Race
Datatyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Other Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2]
- C0034510
Similar models
Informed Consent and Demographics
- StudyEvent: ODM
C0008972 (UMLS CUI [1,2])
C0021403 (UMLS CUI [2,1])
C0008972 (UMLS CUI [2,2])
C0021400 (UMLS CUI [3,1])
C0008972 (UMLS CUI [3,2])
C0600091 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0034510 (UMLS CUI [2])