Information:
Fel:
ID
25677
Beskrivning
Screening and Visit 1 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731 Study ID: 100382 Clinical Study ID: 100382 Study Title: Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals’ Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289731 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Nyckelord
Versioner (2)
- 2017-09-09 2017-09-09 -
- 2017-09-09 2017-09-09 -
Uppladdad den
9 september 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Screening and Visit 1 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731
Screening and Visit 1 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731
Similar models
Screening and Visit 1 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity NCT00289731
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
Black (1)
CL Item
Arabic/North African (4)
CL Item
White/Caucasian (2)
CL Item
East & South East Asian (5)
CL Item
South Asian (6)
CL Item
Other (9)
Other Race
Item
Other Race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date blood sample taken
Item
Date blood sample taken
boolean
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
meet entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Compliance
Item
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
boolean
C2348568 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
age at first vaccination
Item
A male or female aged 41 years or older at the time of the first vaccination.
boolean
C0001779 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
Informed consent
Item
Written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
health status
Item
Healthy and non-healthy subjects, including those taking medications, as established by medical history and clinical examination before entering into the study.
boolean
C0018759 (UMLS CUI [1])
Seronegative Hepatitis A and B
Item
Seronegative at screening for anti-HBs, anti-HBc, HBs antigen and anti-HAV.
boolean
C0019159 (UMLS CUI [1,1])
C0521144 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
C0521144 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2,1])
C0521144 (UMLS CUI [2,2])
child-bearing potential contraception
Item
If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e., intrauterine contraceptive device; oral/long term hormonal contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
boolean
C1960468 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
Use of any investigational or non-registered product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
C1524063 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
History of any hepatitis A or hepatitis B vaccination or infection.
Item
History of any hepatitis A or hepatitis B vaccination or infection.
boolean
C1997459 (UMLS CUI [1])
C1997078 (UMLS CUI [2])
C1960633 (UMLS CUI [3])
C0795623 (UMLS CUI [4])
C1997078 (UMLS CUI [2])
C1960633 (UMLS CUI [3])
C0795623 (UMLS CUI [4])
History of allergic diseases or reactions
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C2106654 (UMLS CUI [1])
Acute disease
Item
Acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
Pregnant or lactating female
Item
Pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
planning pregnancy
Item
Female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period (up to Month 7).
boolean
C0032992 (UMLS CUI [1])
CL Item
Yes, daily (1)
CL Item
Yes, occasionally (2)
CL Item
No (3)
Item
How many cigarettes do you usually smoke on average each day?
integer
C3694146 (UMLS CUI [1])
CL Item
Does not smoke cigarettes (1)
CL Item
Fewer than 20 (2)
CL Item
20 or more (3)
Item
How many cigars do you usually smoke on average per day?
integer
C0678446 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,2])
CL Item
Does not smoke cigars (1)
CL Item
Smoke on average...cigars per day (2)
number of cigars per day
Item
Number of average cigars per day.
integer
C0678446 (UMLS CUI [1,1])
C0439505 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,2])
Item
How much pipe tobacco do you smoke on average per week ?
integer
C0459842 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
C0332174 (UMLS CUI [1,2])
CL Item
Does not smoke pipes (1)
CL Item
Smoke on average...grams per week (2)
amount of weekly pipe tobacco
Item
Amount of average weekly pipe tobacco.
integer
C0459842 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
C0332174 (UMLS CUI [1,2])
age start smoking
Item
How old were you when you started smoking (= became a smoker) ?
integer
C3260574 (UMLS CUI [1])
reduced smoking
Item
Compared with two years ago would you say you now have reduced smoking ?
boolean
C0453996 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0392756 (UMLS CUI [1,2])
increased smoking
Item
Compared with two years ago would you say you now have increased smoking?
boolean
C0453996 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,2])
ever tried stop smoking
Item
Have you ever tried to stop smoking?
boolean
C0422611 (UMLS CUI [1])
Item
Have you ever smoked?
integer
C0453996 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
CL Item
Yes, daily (1)
CL Item
Yes, occasionally (2)
CL Item
No (3)
Item
How long ago did you stop smoking?
integer
C0841002 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
CL Item
Less than two years ago (1)
CL Item
Two years ago or longer (2)
alcohol consumption
Item
During the last twelve months, have you ever drunk alcoholic beverages (even if you drank it only once)?
boolean
C0001948 (UMLS CUI [1])
alcohol consumption
Item
During the last six months, have you ever had 6 or more glasses (possible different) alcoholic beverages in one day?
boolean
C0001948 (UMLS CUI [1])
Item
During the last six months, how often have you had 6 or more (possible different) alcoholic beverages in one day?
integer
C0001948 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,2])
Code List
During the last six months, how often have you had 6 or more (possible different) alcoholic beverages in one day?
CL Item
Everyday (1)
CL Item
5 to 6 times a week (2)
CL Item
3 to 4 times a week (3)
CL Item
1 to 2 times a week (4)
CL Item
1 to 3 times a month (5)
CL Item
3 to 5 times in six months (6)
CL Item
1 to 2 times in six months (7)
alcohol consumption days of the week
Item
Do you usually drink alcoholic beverages during the days of the week (Monday till Thursday)?
boolean
C0001948 (UMLS CUI [1,1])
C0585023 (UMLS CUI [1,2])
C0585023 (UMLS CUI [1,2])
Item
During how many days of the week (Monday till Thursday) do you usually drink alcoholic beverages?
integer
C0001948 (UMLS CUI [1,1])
C0585023 (UMLS CUI [1,2])
C0585023 (UMLS CUI [1,2])
Code List
During how many days of the week (Monday till Thursday) do you usually drink alcoholic beverages?
CL Item
1 day (1)
CL Item
2 days (2)
CL Item
3 days (3)
CL Item
4 days (4)
Item
How many glasses on average do you drink during weekdays (Monday till Thursday) ?
integer
C0551555 (UMLS CUI [1,1])
C0680189 (UMLS CUI [1,2])
C0680189 (UMLS CUI [1,2])
Code List
How many glasses on average do you drink during weekdays (Monday till Thursday) ?
CL Item
11 or more glasses (1)
CL Item
7 to 10 glasses (2)
CL Item
6 glasses (3)
CL Item
4 of 5 glasses (4)
CL Item
3 glasses (5)
CL Item
2 glasses (6)
CL Item
1 glass (7)
alcohol consumption weekend
Item
Do you usually drink alcoholic beverages during weekend (Friday till Sunday)?
boolean
C0001948 (UMLS CUI [1,1])
C0680190 (UMLS CUI [1,2])
C0680190 (UMLS CUI [1,2])
Item
During how many days of the weekend (Friday till Sunday) do you usually drink alcoholic beverages?
integer
C0001948 (UMLS CUI [1,1])
C0680190 (UMLS CUI [1,2])
C0680190 (UMLS CUI [1,2])
Code List
During how many days of the weekend (Friday till Sunday) do you usually drink alcoholic beverages?
CL Item
1 day (1)
CL Item
2 days (2)
CL Item
3 days (3)
Item
How many glasses on average do you drink during the days of the weekend (Friday till Sunday) ?
integer
C0551555 (UMLS CUI [1,1])
C0556334 (UMLS CUI [1,2])
C0556334 (UMLS CUI [1,2])
Code List
How many glasses on average do you drink during the days of the weekend (Friday till Sunday) ?
CL Item
11 or more glasses (1)
CL Item
7 to 10 glasses (2)
CL Item
6 glasses (3)
CL Item
4 of 5 glasses (4)
CL Item
3 glasses (5)
CL Item
2 glasses (6)
CL Item
1 glass (7)
need to cut down drinking
Item
Have you ever felt the need to cut down on your drinking ?
boolean
C3161943 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,2])
annoyed by criticism of your drinking
Item
Have you ever felt annoyed by criticism of your drinking ?
boolean
C0001948 (UMLS CUI [1,1])
C0870379 (UMLS CUI [1,2])
C3843165 (UMLS CUI [1,3])
C0870379 (UMLS CUI [1,2])
C3843165 (UMLS CUI [1,3])
guilty about drinking
Item
Have you ever felt guilty about drinking ?
boolean
C2199077 (UMLS CUI [1])
morning drinking
Item
Did you ever take a morning eye opener?
boolean
C0001948 (UMLS CUI [1,1])
C0683352 (UMLS CUI [1,2])
C0683352 (UMLS CUI [1,2])
Item Group
Medical history and medical condition at study start (including medical history and chronic diseases)
C0262926 (UMLS CUI-1)
disease prior to the study start or any ongoing chronic disease
Item
Are you aware of any past disease prior to the study start or any ongoing chronic disease at the time of study start?
boolean
C0012634 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0008976 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Disease
Item
name of disease
text
C0012634 (UMLS CUI [1])
disease in the past
Item
Past
boolean
C0012634 (UMLS CUI [1,1])
C0332119 (UMLS CUI [1,2])
C0332119 (UMLS CUI [1,2])
Ongoing disease
Item
Current
boolean
C0549178 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
Start date of disease
Item
Start date
date
C0012634 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Disease requires medication
Item
Requiring medication?
boolean
C0012634 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,2])
Item
Has a urine sample been taken?
integer
C0200354 (UMLS CUI [1,1])
C1880076 (UMLS CUI [1,2])
C1880076 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (not of childbearing potential or male) (3)
Date of urine sample
Item
Date of urine sample
date
C2371162 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Result
integer
C0430056 (UMLS CUI [1,1])
C0427777 (UMLS CUI [1,2])
C0427777 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Pre-vaccination assessment
C0220825 (UMLS CUI-1)
C0005903 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0005903 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0449444 (UMLS CUI [1,2])
CL Item
Axillary (A)
CL Item
Oral (O)
Item Group
Vaccine administration - Twinrix group
C2368628 (UMLS CUI-1)
C0593953 (UMLS CUI-2)
C0593953 (UMLS CUI-2)
Date of vaccination
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,2])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,2])
CL Item
Twinrix Vaccine (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments vaccine administration
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
Item Group
Vaccine administration - Engerix-B and Havrix group
C2368628 (UMLS CUI-1)
C0116078 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
C0116078 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
Date of vaccination
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C0700881 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0700881 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0116078 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,2])
CL Item
Engerix-B Vaccine (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0700881 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,2])
CL Item
Havrix Vaccine (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments vaccine administration
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0700881 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0700881 (UMLS CUI [1,4])
Item Group
Vaccine administration - Hbvaxpro and Vaqta group
C2368628 (UMLS CUI-1)
C0379473 (UMLS CUI-2)
C1445761 (UMLS CUI-3)
C0379473 (UMLS CUI-2)
C1445761 (UMLS CUI-3)
Date of vaccination
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C0379473 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C0379473 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C1445761 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,2])
CL Item
HB VAX PRO (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0379473 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,2])
CL Item
Vaqta Vaccine (1)
CL Item
Replacement vial (*) (2)
CL Item
Wrong vial number (*) (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments vaccine administration
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C1445761 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C1445761 (UMLS CUI [1,4])
Item Group
Vaccine administration - Vaccination 1
C2368628 (UMLS CUI-1)
C0474232 (UMLS CUI-2)
C0474232 (UMLS CUI-2)
Item
Why not administered?
text
C2368628 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Other, please specify (OTH)
Number of SAE
Item
Please specify SAE N°
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Other reason for non administration of vaccine
Item
Other, please specify
text
C2368628 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Please tick who took the decision
integer
C0679006 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
CL Item
Investigator (1)
CL Item
Subject (2)
Item Group
Serious adverse event - Post-vaccination observation
C1519255 (UMLS CUI-1)
C2368628 (UMLS CUI-2)
C0687676 (UMLS CUI-3)
C2368628 (UMLS CUI-2)
C0687676 (UMLS CUI-3)
Item
Has the subject experienced any serious adverse events within one month (minimum 30 days) post- vaccination?
text
C1519255 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Code List
Has the subject experienced any serious adverse events within one month (minimum 30 days) post- vaccination?
CL Item
Information not retrievable (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, fill in the Serious Adverse Event form. (Y)