ID

35790

Beschrijving

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

Trefwoorden

Versies (2)
  1. 3/22/19 3/22/19 -
  2. 3/23/19 3/23/19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

March 23, 2019

DOI

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Licentie

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

Engels

Vaccine administration, Randomization/ Treatment allocation

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit type
Beschrijving

Visit type

Datatype

integer

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

day month year

Datatype

date

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

Randomisation/ Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Beschrijving

Treatment number

Datatype

text

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

Vaccine administration

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

day month year

Datatype

date

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

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

Datatype

float

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

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

Datatype

float

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

Route of measurement

Datatype

text

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

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.

Datatype

integer

Alias
UMLS CUI [1]
C2368628
Replacement vial identifier
Beschrijving

Replacement vial identifier

Datatype

text

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

Only to fill in for Visit 3.

Datatype

integer

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

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

Datatype

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?
Beschrijving

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

Datatype

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
Beschrijving

No protocol vaccine administration: Side

Datatype

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
Beschrijving

No protocol vaccine administration: Anatomic structure

Datatype

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
Beschrijving

No protocol vaccine administration: Route of administration

Datatype

text

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

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

Datatype

text

Alias
UMLS CUI [1]
C0947611
No vaccine administration
Beschrijving

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
Beschrijving

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

Datatype

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.
Beschrijving

SAE Number

Datatype

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.
Beschrijving

AE Number

Datatype

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.
Beschrijving

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

Datatype

text

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

Decision taken

Datatype

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1272696
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Similar models

Vaccine administration, Randomization/ Treatment allocation

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
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