ID
35077
Beschrijving
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 conclude the study. It should be filled out at the phone contact and rechecked at visit 3. 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"
Link
https://clinicaltrials.gov/ct2/show/NCT00321373
Trefwoorden
Versies (2)
- 13-02-19 13-02-19 -
- 29-05-19 29-05-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
13 februari 2019
DOI
Voor een aanvraag inloggen.
Licentie
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
Study Conclusion
- StudyEvent: ODM
Beschrijving
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Beschrijving
Follow-Up Studies
Datatype
boolean
Alias
- UMLS CUI [1]
- C0016441
Beschrijving
if subject not willing to be contacted
Datatype
text
Alias
- UMLS CUI [1]
- C0566251
Beschrijving
Adverse Events or Serious Adverse Events
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C1519255
Beschrijving
Other
Datatype
text
Alias
- UMLS CUI [1]
- C0205394
Beschrijving
Occurence of SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2745955
Beschrijving
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beschrijving
Status of Treatment Blind
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0749659
- UMLS CUI [1,2]
- C2347038
Beschrijving
If treatment blind was broken
Datatype
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beschrijving
If treatment blind was broken
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Beschrijving
If there was another reason for breaking the treatment blind.
Datatype
text
Beschrijving
Investigators Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator's Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Investigators Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
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Study Conclusion
- StudyEvent: ODM
C1519255 (UMLS CUI [2])
C2745955 (UMLS CUI [1,2])
C2347038 (UMLS CUI-2)
C2347038 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])