ID

35160

Beschreibung

Study ID: 107495 Clinical Study ID: 107495 Study Title: A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H5N1) influenza vaccine (split virus formulation) adjuvanted with AS03, administered according to different vaccination schedules. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00430521 https://clinicaltrials.gov/ct2/show/NCT00430521 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Pandemic influenza vaccine (GSK1119711A)-formulation 1, Pandemic influenza vaccine (GSK1119711A)-formulation 2 Trade Name: N/A Study Indication: Influenza There are 4 workbooks (WB): WB 1: Protocol 107495, (H5N1-012), Groups: VT/VT/6Mo, VT/IN/6Mo WB 2: Protocol 107495, (H5N1-012), Groups: VT/VT/12Mo, VT/IN/12Mo WB 3: Protocol 107495 (H5N1-012) GROUPS: 2VT/VT/6MO, 2VT/IN/6MO WB 4: Protocol 107495 (H5N1-012) Groups: 2VT/VT/12Mo, 2VT/IN/12Mo Every Workbook has the following visits: Visit Day 0 (Screening, Dose 1), Visit Day 21, Visit Month 6, Visit Month 12 and Visit Month 18. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section, followed by a final study conclusion after Month 18. Workbook 1 schedules a vaccination at screening and Month 6 each, Workbook 2 at Screening and Month 12. 30 days after the first vaccination there is an additional telephone contact. After the second vaccination additional visits/contacts are necessary in both workbooks: a visit at Month 6/12 + 7 and 21 days and a telephone contact on Month 6/12 + 30 days. Workbook 3 schedules a vaccination at screening, Day 21 and Month 6 and Workbook 4 at screening, Day 21 and Month 12. After the second vaccination there is an additional visit on Day 42 and a telephone contact on day 51. After the third vaccination there are additional visits/contacts: visits at Month 6/12 + 7 and 21 days and a telephone contact at Month 6/12 + 30 days. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section. This document contains Telephone contact form. It has to be filled in for: WB 1: Day 30 and Month 6 + 30 D WB 2: Day 30 and Month 12 + 30 D WB 3: Day 51 and Month 6 + 30 D WB 4: Day 51 and Month 12 + 30 D

Link

https://clinicaltrials.gov/ct2/show/NCT00430521

Stichworte

  1. 18.02.19 18.02.19 -
  2. 20.02.19 20.02.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. Februar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0

Modell Kommentare :

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Evaluation of reactogenicity and immunogenicity of pandemic monovalent (H5N1) influenza vaccine in adults, NCT00430521

Telephone contact

  1. StudyEvent: ODM
    1. Telephone contact
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Workbook number
Beschreibung

Workbook number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Beschreibung

Visit type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Telephone contact
Beschreibung

Telephone contact

Alias
UMLS CUI-1
C0302186
Has information been obtained?
Beschreibung

Check elimination criteria. Recording of non-serious AEs that may have occurred since last visit. Recording of unresolved AEs that may have occurred since last visit. Recording of any serious adverse events. Additionally for Month 6 + 30 days (WB1+3) or Month 12 + 30 days (WB2+4): Study conclusion Month 6/12 + 30 days.

Datentyp

text

Alias
UMLS CUI [1]
C1955348
Date of contact
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0302186

Ähnliche Modelle

Telephone contact

  1. StudyEvent: ODM
    1. Telephone contact
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Code List
Workbook number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
CL Item
WB 3 (3)
CL Item
WB 4 (4)
Item
Visit type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Day 30 (WB1+2) (1)
CL Item
Day 51 (WB3+4) (2)
CL Item
Month 6 + 30 D (WB1+3) (3)
CL Item
Month 12 + 30 D (WB2+4) (4)
Item Group
Telephone contact
C0302186 (UMLS CUI-1)
Item
Has information been obtained?
text
C1955348 (UMLS CUI [1])
Code List
Has information been obtained?
CL Item
No (N)
CL Item
Yes (Y)
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C0302186 (UMLS CUI [1,2])

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