ID

35160

Beschrijving

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

Trefwoorden

  1. 18-02-19 18-02-19 -
  2. 20-02-19 20-02-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 februari 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Telephone contact

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

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Workbook number
Beschrijving

Workbook number

Datatype

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Beschrijving

Visit type

Datatype

integer

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

Telephone contact

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

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.

Datatype

text

Alias
UMLS CUI [1]
C1955348
Date of contact
Beschrijving

day month year

Datatype

date

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

Similar models

Telephone contact

  1. StudyEvent: ODM
    1. Telephone contact
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial