ID

35158

Descrição

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 the Vaccine administration form. It has to be filled in for screening for all workbooks (WB1-4). It also has to be filled in for: WB 1: Visit Month 6 WB 2: Visit Month 12 WB 3: Visit Day 21 and Visit Month 6 WB 4: Visit Day 21 and Visit Month 12

Link

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

Palavras-chave

Versões (2)
  1. 18/02/2019 18/02/2019 -
  2. 20/02/2019 20/02/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

20 de fevereiro de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Evaluation of reactogenicity and immunogenicity of pandemic monovalent (H5N1) influenza vaccine in adults, NCT00430521

Inglês

Vaccine administration

1 Formulários  
  1. StudyEvent: ODM
    1. Vaccine administration
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Workbook number
Descrição

Workbook number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Descrição

Visit type

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Vaccine administration
Descrição

Vaccine administration

Alias
UMLS CUI-1
C2368628
Date of vaccine administration
Descrição

day month year (fill in only if different from visit date)

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Pre-Vaccination temperature
Descrição

Pre-Vaccination temperature

Tipo de dados

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0042196
°C
Route of temperature measurement
Descrição

Route of temperature measurement

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Vaccine administration
Descrição

(only one box must be ticked by vaccine). If you tick Not administered, please complete "Reason for non administration" in the following itemgroup.

Tipo de dados

text

Alias
UMLS CUI [1]
C2368628
If replacement vial, note the number
Descrição

Replacement vial number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
If wrong vial, note number
Descrição

Wrong vial number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0600091
Has the study vaccine been administered according to the Protocol?
Descrição

Admnistration according to protocol: Deltoid, non dominant (arm), I.M. If you tick "No", please fill in all Items that apply in the following.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Side of vaccination
Descrição

Fill in only if study vaccine has been not administered according to the protocol.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0441987
Site of vaccination
Descrição

Fill in only if study vaccine has been not administered according to the protocol.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042196
Route of vaccination
Descrição

Fill in only if study vaccine has been not administered according to the protocol.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042196
Reason for non administration
Descrição

Reason for non administration

Alias
UMLS CUI-1
C1533734
UMLS CUI-2
C0392360
UMLS CUI-3
C1272696
Reason for non administration
Descrição

If you tick SAE please complete and submit SAE report. If you tick Non-serious AE please complete Non-Serious Adverse Event section.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
SAE Number
Descrição

Fill in this item if you ticked SAE as reason for non administration

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE Number
Descrição

Fill in this item if you ticked Non-serious AE as reason for non administration

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Solicited AE Number
Descrição

Solicited AE Number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1517001
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0237753
If there is an other reason for non administration, please specify
Descrição

(e.g.: consent withdrawal, Protocol violation, …)

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C1272696
Please tick who made the decision
Descrição

Decision maker

Tipo de dados

text

Alias
UMLS CUI [1]
C0679006
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Similar models

Vaccine administration

1 Formulários
  1. StudyEvent: ODM
    1. Vaccine administration
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Workbook number
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])
Visit type
Code List
Visit type
CL Item
Screening (all WB's) (1)
CL Item
Visit Month 6 (WB1+3) (2)
CL Item
Visit Month 12 (WB2+4) (3)
CL Item
Visit Day 21(WB3+4) (4)
Item Group
Vaccine administration
C2368628 (UMLS CUI-1)
Date of vaccine administration
Item
Date of vaccine administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Item
Route of temperature measurement
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Route of temperature measurement
Code List
Route of temperature measurement
CL Item
Axillary (preferable)  (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
H5N1 Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial number
Item
If replacement vial, note the number
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
If wrong vial, note number
text
C0184301 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item
Has the study vaccine been administered according to the Protocol?
text
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Administration of study vaccine according to the protocol
Code List
Has the study vaccine been administered according to the Protocol?
CL Item
Yes (Y)
CL Item
No (N)
Item
Side of vaccination
integer
C0042196 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Side of vaccination
Code List
Side of vaccination
CL Item
Dominant (1)
CL Item
Non-Dominant (2)
Item
Site of vaccination
integer
C1515974 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Site of vaccination
Code List
Site of vaccination
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route of vaccination
integer
C0013153 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Route of vaccination
Code List
Route of vaccination
CL Item
I.M. (1)
CL Item
S.C. (2)
Item Group
Reason for non administration
C1533734 (UMLS CUI-1)
C0392360 (UMLS CUI-2)
C1272696 (UMLS CUI-3)
Item
Reason for non administration
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Reason for non administration
Code List
Reason for non administration
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE Number
Item
Solicited AE Number
text
C1517001 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Other reason for non administration
Item
If there is an other reason for non administration, please specify
text
C3840932 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Please tick who made the decision
text
C0679006 (UMLS CUI [1])
Decision maker
Code List
Please tick who made the decision
CL Item
Investigator (I)
CL Item
Subject (S)
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