ID

35744

Description

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 Elimination criteria and Contraindications form. It has to be filled in for each visit.

Link

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

Keywords

Versions (1)
  1. 3/20/19 3/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 20, 2019

DOI

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License

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

English

Elimination criteria during the study, Contraindications

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit date
Description

Day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Elimination criteria
Description

Elimination criteria

Alias
UMLS CUI-1
C0680251
Administration of any vaccine (other than the candidate vaccines) between Day 0 and Day 42
Description

Between Day 0 and Day 42 = Between Visit 1 and Visit 5

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
Chronic administration of immunosuppressants or other immune-modifying drugs during the study period. (For glucocorticoids, this will mean prednisone, or equivalent, >= 10 mg/day. Inhaled and topical steroids are allowed.)
Description

Chronic administration is defined as more than 14 consecutive days

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C2065041
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C2064827
UMLS CUI [3,2]
C0683607
Administration of immunoglobulins and/or any blood products during the study period.
Description

Administration of immunoglobulins and/or any blood products

Data type

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C2347804
Use of any investigational or non-registered product (drug or vaccine) other than the candidate vaccine during the study period.
Description

Use of investigational or non-registered product

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
Contraindications to subsequent vaccination
Description

Contraindications to subsequent vaccination

Alias
UMLS CUI-1
C0522473
UMLS CUI-2
C0042196
Pregnancy.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Anaphylaxis in response to an earlier vaccine dose
Description

Anaphylaxis to vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0042196
Discovery of any health condition which, in the investigator’s opinion, places the subject at increased risk from receipt of further investigational product; or discovery of a change in the subject’s status which renders him/her unable to comply with protocol-mandated safety follow-up.
Description

Medical condition, risk for investigational product/ change of compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0304229
UMLS CUI [2,1]
C0443172
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0525058
UMLS CUI [2,4]
C1299582
If the following AE occurs prior to or at the time of the Day 21 scheduled visit, the subject may be withdrawn at the discretion of the investigator or the subject may be vaccinated at a later date, however, within the time window specified in the protocol. The subject must be followed until resolution of the event as with any AE
Description

Occurrence of AE

Data type

boolean

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0877248
Acute disease at the time of vaccination. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection with or without low-grade fever.
Description

(Acute disease is defined as the presence of a moderate or severe illness with or without fever)

Data type

boolean

Alias
UMLS CUI [1]
C0001314
UMLS CUI [2,1]
C0683607
UMLS CUI [2,2]
C0011991
UMLS CUI [3,1]
C0683607
UMLS CUI [3,2]
C0041912
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Similar models

Elimination criteria during the study, Contraindications

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit date
Item
Visit date
date
C1320303 (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
Screening (1)
CL Item
Visit 1 (2)
CL Item
Visit 2 (3)
CL Item
Visit 3 (4)
CL Item
Visit 4 (5)
CL Item
Visit 5 (6)
CL Item
Telephone Contact (7)
CL Item
Visit 6  (8)
Item Group
Elimination criteria
C0680251 (UMLS CUI-1)
Administration of any vaccine not applicable with study protocol
Item
Administration of any vaccine (other than the candidate vaccines) between Day 0 and Day 42
boolean
C2368628 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Chronic administration of immunosuppressants or other immune-modifying drugs
Item
Chronic administration of immunosuppressants or other immune-modifying drugs during the study period. (For glucocorticoids, this will mean prednisone, or equivalent, >= 10 mg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C2065041 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C2064827 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Administration of immunoglobulins and/or any blood products
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0456388 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
Use of investigational or non-registered product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the candidate vaccine during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Item Group
Contraindications to subsequent vaccination
C0522473 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Pregnancy
Item
Pregnancy.
boolean
C0032961 (UMLS CUI [1])
Anaphylaxis to vaccination
Item
Anaphylaxis in response to an earlier vaccine dose
boolean
C0002792 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Medical condition, risk for investigational product/ change of compliance
Item
Discovery of any health condition which, in the investigator’s opinion, places the subject at increased risk from receipt of further investigational product; or discovery of a change in the subject’s status which renders him/her unable to comply with protocol-mandated safety follow-up.
boolean
C0012634 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0443172 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
Occurrence of AE
Item
If the following AE occurs prior to or at the time of the Day 21 scheduled visit, the subject may be withdrawn at the discretion of the investigator or the subject may be vaccinated at a later date, however, within the time window specified in the protocol. The subject must be followed until resolution of the event as with any AE
boolean
C2745955 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Acute disease
Item
Acute disease at the time of vaccination. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection with or without low-grade fever.
boolean
C0001314 (UMLS CUI [1])
C0683607 (UMLS CUI [2,1])
C0011991 (UMLS CUI [2,2])
C0683607 (UMLS CUI [3,1])
C0041912 (UMLS CUI [3,2])
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