ID
35775
Description
Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Check for study continuation. It has to be filled in for each Visit.
Lien
https://clinicaltrials.gov/ct2/show/NCT00510874
Mots-clés
Versions (1)
- 22/03/2019 22/03/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
22 mars 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874
Check for study continuation
- StudyEvent: ODM
Description
Check for study continuation
Alias
- UMLS CUI-1
- C0805733
- UMLS CUI-2
- C0008976
Description
Continuation status
Type de données
text
Alias
- UMLS CUI [1,1]
- C0805733
- UMLS CUI [1,2]
- C0008976
Description
If you tick SAE: Please complete and submit SAE report. If you tick AEX: Please complete Non-serious Adverse Event section.
Type de données
text
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C0805733
- UMLS CUI [1,3]
- C0566251
Description
SAE Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
AE Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
(e.g.: consent withdrawal, Protocol violation, …)
Type de données
text
Alias
- UMLS CUI [1]
- C3840932
Description
Decision taken
Type de données
text
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0679006
Similar models
Check for study continuation
- StudyEvent: ODM
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI [1,2])
C0805733 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])