ID

35848

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 Concomitant Medication form. At each study visit, the investigator should question the subject about any medication(s) taken. During the period starting with administration of the first dose of study vaccine and ending 84 days after the first dose of study vaccine, concomitant medication administered for the treatment of an AE or SAE must be recorded in the CRF with generic name of the medication (trade names are allowed for combination drugs only), medical indication (including which AE/SAE), total daily dose, route of administration, start and end dates of treatment. Similarly, concomitant medication administered for the treatment of an SAE, at any time, must be recorded on the SAE Report Form.

Link

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

Trefwoorden

Versies (2)
  1. 25-03-19 25-03-19 -
  2. 27-03-19 27-03-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

27 maart 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

Concomitant Medication

1 Formulieren  
  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Phase type
Beschrijving

Phase type

Datatype

integer

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C0332307
Concomitant Medication
Beschrijving

Concomitant Medication

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0013227
Have any medications/treatments been administered during the timeframe specified in the protocol?
Beschrijving

All concomitant medication, with the exception of vitamins and/or dietary supplements, administered at ANY time during the period starting with administration of each dose of study vaccine and ending 21 days after each dose of study vaccine are to be recorded with generic name of the medication (trade names are allowed for combination drugs, i.e., multi-component drugs), medical indication, total daily dose, route of administration, start and end dates of treatment. Any treatments and/or medications specifically contraindicated, e.g., any immunoglobulins, other blood products and any immune modifying drugs administered within three months preceding the vaccination or at any time during the study period are to be recorded with generic name of the medication (trade names are allowed for combination drugs only), medical indication, total daily dose, route of administration, start and end dates of treatment. Any investigational medication administered throughout the study (i.e., from Visit "Day 0" through Visit "Day 42") must be recorded in the eCRF. (PROTOCOL VIOLATION)

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2347852
Trade / Generic Name of medication
Beschrijving

Trade / Generic Name of medication

Datatype

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0013227
Medical indication of concomitant medication
Beschrijving

A prophylactic medication is a medication administered in the absence of ANY symptom and in anticipation of a reaction to the vaccination (e.g., an anti-pyretic is considered to be prophylactic when it is given in the absence of fever and any other symptom, to prevent fever from occurring). Given that an important goal of this protocol is to study the relative tolerability of various regimens, the use of prophylactic medications to prevent or pre-empt symptoms due to vaccination is specifically prohibited.

Datatype

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
If other medical indication of concomitant medication, please specify
Beschrijving

Other medical indication

Datatype

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0013227
Total daily dose
Beschrijving

Total daily dose

Datatype

text

Alias
UMLS CUI [1]
C2826638
Route of medication administration
Beschrijving

Route of medication administration

Datatype

text

Alias
UMLS CUI [1]
C0013153
Start date of concomitant medication
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C2826734
End date of concomitant medication
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C2826744
Tick if concomitant medication continuing after "Day 42"
Beschrijving

Concomitant medication, continious

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Comment for GSK
Beschrijving

Comment for GSK

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
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Similar models

Concomitant Medication

1 Formulieren
  1. StudyEvent: ODM
    1. Concomitant Medication
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
Phase type
integer
C0205390 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Phase type
CL Item
active phase (1)
CL Item
after telephone contact (2)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Item
Have any medications/treatments been administered during the timeframe specified in the protocol?
text
C0013227 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Concomitant vaccination
Code List
Have any medications/treatments been administered during the timeframe specified in the protocol?
CL Item
No (N)
CL Item
Yes (Y)
Trade / Generic Name of medication
Item
Trade / Generic Name of medication
text
C2360065 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Medical indication of concomitant medication
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical indication
Code List
Medical indication of concomitant medication
CL Item
Prophylactic (1)
Other medical indication
Item
If other medical indication of concomitant medication, please specify
text
C0205394 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Total daily dose
Item
Total daily dose
text
C2826638 (UMLS CUI [1])
Item
Route of medication administration
text
C0013153 (UMLS CUI [1])
Route of vaccine administration
Code List
Route of medication administration
CL Item
Intradermal (ID)
CL Item
Parenteral (PE)
CL Item
Inhalation (IH)
CL Item
Oral (PO)
CL Item
Intramuscular (IM)
CL Item
Subcutaneous (SC)
CL Item
Intravenous (IV)
CL Item
Sublingual (SL)
CL Item
Intranasal (NA)
CL Item
Transdermal (TD)
CL Item
Other (OTH)
CL Item
Unknown (UNK)
CL Item
External (EXT)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Rectal (PR)
CL Item
Topical (TO)
CL Item
Vaginal (VA)
Start date of concomitant medication
Item
Start date of concomitant medication
date
C2826734 (UMLS CUI [1])
End date of concomitant medication
Item
End date of concomitant medication
date
C2826744 (UMLS CUI [1])
Concomitant medication, continious
Item
Tick if concomitant medication continuing after "Day 42"
boolean
C2826666 (UMLS CUI [1])
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
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