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ID

35790

Beschreibung

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 Vaccine administration and Randomization/ Treatment allocation form. The Vaccine administration has to be filled in for Visit 1 and Visit 3. The Randomization/ Treatment allocation has to be filled in for Visit 1.

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Stichworte

Versionen (2)
  1. 22.03.19 22.03.19 -
  2. 23.03.19 23.03.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

23. März 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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    Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

    Englisch

    Vaccine administration, Randomization/ Treatment allocation

    1 Formulare  
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beschreibung

    Subject Number

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit type
    Beschreibung

    Visit type

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Visit date
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Randomisation/ Treatment Allocation
    Beschreibung

    Randomisation/ Treatment Allocation

    Alias
    UMLS CUI-1
    C0034656
    Record treatment number
    Beschreibung

    Treatment number

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1522541
    UMLS CUI [1,2]
    C0600091
    Vaccine administration
    Beschreibung

    Vaccine administration

    Alias
    UMLS CUI-1
    C2368628
    Date if different from visit date
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2368628
    Pre-Vaccination temperature (°C)
    Beschreibung

    Choose either this unit of measurement OR °F in the following item.

    Datentyp

    float

    Maßeinheiten
    • °C
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0042196
    °C
    Pre-Vaccination temperature (°F)
    Beschreibung

    Choose either this unit of measurement OR °C in the item above.

    Datentyp

    float

    Maßeinheiten
    • °F
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0042196
    °F
    Route of measurement
    Beschreibung

    Route of measurement

    Datentyp

    text

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

    If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event report. Wrong vial number: Option for visit 3 only.

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2368628
    Replacement vial identifier
    Beschreibung

    Replacement vial identifier

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0184301
    UMLS CUI [1,2]
    C0559956
    UMLS CUI [1,3]
    C0600091
    Wrong vial number
    Beschreibung

    Only to fill in for Visit 3.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0184301
    UMLS CUI [1,2]
    C0600091
    UMLS CUI [1,3]
    C3827420
    Side/ Site of vaccine administration
    Beschreibung

    According to the protocol: Take the non dominant side. Take deltoid I.M. as route for vaccine administration

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0441987
    UMLS CUI [2]
    C0013153
    Has the study vaccine been administered according to the Protocol?
    Beschreibung

    According to the protocol: The vaccine was administered in deltoid I.M of the non dominant side.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C2348563
    If study vaccine has been NOT administered according to the Protocol, please tick the side that apply
    Beschreibung

    No protocol vaccine administration: Side

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1518384
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [1,3]
    C0441987
    If study vaccine has been NOT administered according to the Protocol, please tick the site (anatomic structure) that apply
    Beschreibung

    No protocol vaccine administration: Anatomic structure

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1518384
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [1,3]
    C0700276
    If study vaccine has been NOT administered according to the Protocol, please tick the route of administration that apply
    Beschreibung

    No protocol vaccine administration: Route of administration

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1518384
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [1,3]
    C0013153
    Comment
    Beschreibung

    If study vaccine has been NOT administered according to the Protocol, please comment if necessary.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    No vaccine administration
    Beschreibung

    No vaccine administration

    Alias
    UMLS CUI-1
    C2368628
    UMLS CUI-2
    C1272696
    If vaccine administration was not done, please tick the major reason for non administration of vaccine
    Beschreibung

    If you tick SAE: Please complete and submit SAE report. If you tick AEX: Please complete Non-serious Adverse Event section.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1272696
    UMLS CUI [1,3]
    C1549995
    If you ticked SAE as primary reason for non administration of vaccine, please specify SAE Number.
    Beschreibung

    SAE Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    If you ticked AE as primary reason for non administration of vaccine, please specify AE Number.
    Beschreibung

    AE Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    If you ticked other reason as primary reason for non administration of vaccine, please specify.
    Beschreibung

    (e.g.: consent withdrawal, Protocol violation, …) If any prophylactic antipyretics are administred it is considered as a Protocol violation

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C3840932
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [1,3]
    C1272696
    Please tick who made the decision
    Beschreibung

    Decision taken

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0679006
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [1,3]
    C1272696
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Vaccine administration, Randomization/ Treatment allocation

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Visit 1 (1)
    CL Item
    Visit 3 (2)
    Visit date
    Item
    Visit date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Randomisation/ Treatment Allocation
    C0034656 (UMLS CUI-1)
    Treatment number
    Item
    Record treatment number
    text
    C1522541 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item Group
    Vaccine administration
    C2368628 (UMLS CUI-1)
    Date of vaccine administration
    Item
    Date if different from visit date
    date
    C0011008 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    Pre-Vaccination temperature (°C)
    Item
    Pre-Vaccination temperature (°C)
    float
    C0005903 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    Pre-Vaccination temperature (°F)
    Item
    Pre-Vaccination temperature (°F)
    float
    C0005903 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    Item
    Route of measurement
    text
    C0886414 (UMLS CUI [1,1])
    C0449444 (UMLS CUI [1,2])
    Route of measurement
    Code List
    Route of measurement
    CL Item
    Axillary (A)
    CL Item
    Oral (mandatory) (O)
    CL Item
    Rectal (R)
    Item
    Vaccine administration
    integer
    C2368628 (UMLS CUI [1])
    Vaccine administration
    Code List
    Vaccine administration
    CL Item
    Pandemic Influenza Test Vaccine (1)
    CL Item
    replacement vial (2)
    CL Item
    Wrong viel number (3)
    CL Item
    Not administered (4)
    Replacement vial identifier
    Item
    Replacement vial identifier
    text
    C0184301 (UMLS CUI [1,1])
    C0559956 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Wrong vial number
    Item
    Wrong vial number
    integer
    C0184301 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    C3827420 (UMLS CUI [1,3])
    Item
    Side/ Site of vaccine administration
    text
    C2368628 (UMLS CUI [1,1])
    C0441987 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [2])
    Side/ Site of vaccine administration
    Code List
    Side/ Site of vaccine administration
    CL Item
    Left (L)
    CL Item
    Right (R)
    Item
    Has the study vaccine been administered according to the Protocol?
    text
    C2368628 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    Protocol vaccine administration
    Code List
    Has the study vaccine been administered according to the Protocol?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    If study vaccine has been NOT administered according to the Protocol, please tick the side that apply
    text
    C1518384 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C0441987 (UMLS CUI [1,3])
    Protocol vaccine administration
    Code List
    If study vaccine has been NOT administered according to the Protocol, please tick the side that apply
    CL Item
    Non dominant (N)
    CL Item
    Dominant (D)
    Item
    If study vaccine has been NOT administered according to the Protocol, please tick the site (anatomic structure) that apply
    integer
    C1518384 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C0700276 (UMLS CUI [1,3])
    Protocol vaccine administration
    Code List
    If study vaccine has been NOT administered according to the Protocol, please tick the site (anatomic structure) that apply
    CL Item
    Deltoid (1)
    CL Item
    Thigh (2)
    CL Item
    Buttock (3)
    Item
    If study vaccine has been NOT administered according to the Protocol, please tick the route of administration that apply
    text
    C1518384 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    Protocol vaccine administration
    Code List
    If study vaccine has been NOT administered according to the Protocol, please tick the route of administration that apply
    CL Item
    I.M (M)
    CL Item
    S.C. (SC)
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    No vaccine administration
    C2368628 (UMLS CUI-1)
    C1272696 (UMLS CUI-2)
    Item
    If vaccine administration was not done, please tick the major reason for non administration of vaccine
    text
    C2368628 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    C1549995 (UMLS CUI [1,3])
    Primary reason for non administration of vaccine
    Code List
    If vaccine administration was not done, please tick the major reason for non administration of vaccine
    CL Item
    Serious adverse event (SAE)
    CL Item
    Non-Serious adverse event (AEX)
    CL Item
    Other (OTH)
    SAE Number
    Item
    If you ticked SAE as primary reason for non administration of vaccine, please specify SAE Number.
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    AE Number
    Item
    If you ticked AE as primary reason for non administration of vaccine, please specify AE Number.
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Other reason
    Item
    If you ticked other reason as primary reason for non administration of vaccine, please specify.
    text
    C3840932 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Item
    Please tick who made the decision
    text
    C0679006 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Decision taken
    Code List
    Please tick who made the decision
    CL Item
    Investigator (I)
    CL Item
    Subject (S)
    Zum Seitenanfang zurückkehren 

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