ID
36658
Description
Study ID: 107191 Clinical Study ID: 107191 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 FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years. Patient Level Data: NA Clinicaltrials.gov Identifier: NA EudraCT Number: 2006-000939-97 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A 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"
Mots-clés
Versions (2)
- 13/02/2019 13/02/2019 -
- 29/05/2019 29/05/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
29 mai 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix EudraCT Number 2006-000939-97
Study Conclusion
- StudyEvent: ODM
Description
Follow-Up Studies
Alias
- UMLS CUI-1
- C0016441
Description
Follow-Up Studies
Type de données
boolean
Alias
- UMLS CUI [1]
- C0016441
Description
if subject not willing to be contacted
Type de données
text
Alias
- UMLS CUI [1]
- C0566251
Description
If reason for not willing to be contacted was a (serious) adverse event.
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C1519255
Description
If there was another reason for not willing to be contacted.
Type de données
text
Alias
- UMLS CUI [1]
- C0205394
Description
Occurence of SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2745955
Description
Occurence of Serious Adverse Event
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2745955
Description
If any SAE occurred
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Description
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Elimination Criteria
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
If any elimination criteria become applicable
Type de données
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C1521902
Description
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Description
Status of Treatment Blind
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0749659
- UMLS CUI [1,2]
- C2347038
Description
If treatment blind was broken
Type de données
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Description
If treatment blind was broken
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Description
If there was another reason for breaking the treatment blind.
Type de données
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Investigators Signature
Alias
- UMLS CUI-1
- C2346576
Description
Investigator's Signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
Investigators Name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Study Conclusion
- StudyEvent: ODM
C1519255 (UMLS CUI [2])
C2745955 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C2347038 (UMLS CUI-2)
C2347038 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])