ID
34951
Beschreibung
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 this form is to document any concimtant vaccination, the subject has received during the study. It should be filled out at each visit/contact. At each study visit/contact, the investigator should question the subject about any vaccination(s) taken. - Any vaccine not foreseen in the study protocol administered in the period beginning 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) preceding the dose of study vaccines and ending 30 days after administration of the study vaccines, and in the period beginning 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) preceding the last study visit at Day 180 is to be recorded with trade name, route of administration and date(s) of administration. - Any Flu vaccine administered during the study period is to be recorded with trade name, route of administration and date(s) of administration. 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
Link
https://clinicaltrials.gov/ct2/show/NCT00321373
Stichworte
Versionen (3)
- 05.02.19 05.02.19 -
- 05.02.19 05.02.19 -
- 07.02.19 07.02.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
5. Februar 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373
Concomitant Vaccination
- StudyEvent: ODM
Beschreibung
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Beschreibung
If yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Beschreibung
Concomitant Vaccination Record
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Beschreibung
Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0042210
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beschreibung
Administration date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0042210
Ähnliche Modelle
Concomitant Vaccination
- StudyEvent: ODM
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0042210 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])