Information:
Fel:
ID
35594
Beskrivning
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza
Nyckelord
Versioner (1)
- 2019-03-11 2019-03-11 -
Rättsinnehavare
GSK group of companies
Uppladdad den
11 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631
Similar models
Visit "Day 21"
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Visit
Item
Visit
text
Date of visit
Item
Date of visit
date
Subject Number
Item
Subject Number
integer
Check Elimination Criteria
Item
The following criteria should be checked at each visit subsequent to the first visit.
text
Concomitant Medication
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
boolean
immunosuppressants or immunemodifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period.
boolean
mmunoglobulins
Item
Administration of immunoglobulins and/or any blood products during the study.
boolean
Concomitant Vaccination
Item
Administration of any vaccine other than the study vaccine during the study.
boolean
check for study continuation
Item
Did the subject return for Visit "Day 21"?
boolean
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit
text
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
SAE No.
Item
Please specify SAE No.
integer
AE No.
Item
Please specify AE No.
integer
Specify Other
Item
Specify Other
text
CL Item
Investigator (1)
CL Item
Subject (2)
ANTIBODY DETERMINATION (HI)
Item
Has a blood sample been taken for antibody determination (7.5 mL)?
boolean
Date
Item
Date
date
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Redness
Item
Redness
boolean
Redness Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Swelling
Item
Swelling
boolean
If Yes, record the size
Item
If Yes, record the size
integer
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Induration
Item
Induration
boolean
Induration Size
Item
Size
integer
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Ecchymosis
Item
Ecchymosis
boolean
Ecchymosis Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Pain
Item
Pain
boolean
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (4)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Temperature
Item
Temperature
boolean
t°
Item
t°
float
CL Item
Axillary (preferable) (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Temperature not taken
Item
Not taken (temperature)
boolean
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Fatigue
Item
Fatigue
boolean
CL Item
normal (1)
CL Item
that is easily tolerated (2)
CL Item
that interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
boolean
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Headache
Item
Headache
boolean
CL Item
normal (1)
CL Item
that is easily tolerated (2)
CL Item
that interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Myalgia
Item
Myalgia
boolean
CL Item
normal (1)
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Shivering
Item
Shivering
boolean
CL Item
normal (1)
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Arthralgia
Item
Arthralgia
boolean
CL Item
normal (1)
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Sweating increase
Item
Sweating increase
boolean
CL Item
normal (1)
CL Item
easily tolerated (2)
CL Item
interferes with normal activity (3)
CL Item
that prevents normal activity (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date
Item
Date of last Day of Symptoms
date
Causality
Item
Causality?
boolean
Medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit "Day 0" and Visit "Day 21"?
text
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events between Visit "Day 0" and Visit "Day 21"?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes -> Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as (4)
CL Item
necessary. (necessary.)