ID

25677

Description

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

Keywords

Versions (2)
  1. 9/9/17 9/9/17 -
  2. 9/9/17 9/9/17 -
Uploaded on

September 9, 2017

DOI

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License

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

English

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

1 forms  
Informed consent
Description

Informed consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Description

Center number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Other Race, please specify
Description

If you chose 'Other Race', please specify

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C3845569
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Description

Blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date blood sample taken
Description

Please complete only if different from visit date

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Eligibility check
Description

Eligibility check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Description

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
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.
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1321605
A male or female aged 41 years or older at the time of the first vaccination.
Description

age at first vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0042196
Written informed consent obtained from the subject.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Healthy and non-healthy subjects, including those taking medications, as established by medical history and clinical examination before entering into the study.
Description

health status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
Seronegative at screening for anti-HBs, anti-HBc, HBs antigen and anti-HAV.
Description

Seronegative Hepatitis A and B

Data type

boolean

Alias
UMLS CUI [1,1]
C0019159
UMLS CUI [1,2]
C0521144
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0521144
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.
Description

child-bearing potential contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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.
Description

Use of any investigational or non-registered product

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0013230
History of any hepatitis A or hepatitis B vaccination or infection.
Description

History of any hepatitis A or hepatitis B vaccination or infection.

Data type

boolean

Alias
UMLS CUI [1]
C1997459
UMLS CUI [2]
C1997078
UMLS CUI [3]
C1960633
UMLS CUI [4]
C0795623
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Description

History of allergic diseases or reactions

Data type

boolean

Alias
UMLS CUI [1]
C2106654
Acute disease at the time of enrolment.
Description

Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral/ axillary temperature <37.5°C [< 37.0°C for Czech Republic only]

Data type

boolean

Alias
UMLS CUI [1]
C0001314
Pregnant or lactating female.
Description

Pregnant or lactating female

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period (up to Month 7).
Description

planning pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032992
Smoking history
Description

Smoking history

Alias
UMLS CUI-1
C1519384
Do you smoke?
Description

smoking

Data type

integer

Alias
UMLS CUI [1]
C3241966
How many cigarettes do you usually smoke on average each day?
Description

cigarettes per day

Data type

integer

Alias
UMLS CUI [1]
C3694146
How many cigars do you usually smoke on average per day?
Description

cigars per day

Data type

integer

Alias
UMLS CUI [1,1]
C0678446
UMLS CUI [1,2]
C0439505
Number of average cigars per day.
Description

Only answer, if you smoke cigars.

Data type

integer

Alias
UMLS CUI [1,1]
C0678446
UMLS CUI [1,2]
C0439505
How much pipe tobacco do you smoke on average per week ?
Description

pipe tobacco per week

Data type

integer

Alias
UMLS CUI [1,1]
C0459842
UMLS CUI [1,2]
C0332174
Amount of average weekly pipe tobacco.
Description

amount of weekly pipe tobacco

Data type

integer

Measurement units
  • g
Alias
UMLS CUI [1,1]
C0459842
UMLS CUI [1,2]
C0332174
g
How old were you when you started smoking (= became a smoker) ?
Description

age start smoking

Data type

integer

Measurement units
  • years old
Alias
UMLS CUI [1]
C3260574
years old
Compared with two years ago would you say you now have reduced smoking ?
Description

reduced smoking

Data type

boolean

Alias
UMLS CUI [1,1]
C0453996
UMLS CUI [1,2]
C0392756
Compared with two years ago would you say you now have increased smoking?
Description

increased smoking

Data type

boolean

Alias
UMLS CUI [1,1]
C0453996
UMLS CUI [1,2]
C0205217
Have you ever tried to stop smoking?
Description

ever tried stop smoking

Data type

boolean

Alias
UMLS CUI [1]
C0422611
Have you ever smoked?
Description

Smoking behaviour

Data type

integer

Alias
UMLS CUI [1,1]
C0453996
UMLS CUI [1,2]
C0262926
How long ago did you stop smoking?
Description

stop smoking duration

Data type

integer

Alias
UMLS CUI [1,1]
C0841002
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C0449238
Alcohol consumption questionnaire
Description

Alcohol consumption questionnaire

Alias
UMLS CUI-1
C0001948
During the last twelve months, have you ever drunk alcoholic beverages (even if you drank it only once)?
Description

- Beer (low alcohol level beer excluded), - Wine, sherry, porto, vermouth, - Liquor, advocaat, kir, - Gin, brandy, cognac, whisky, vodka, - Long-drinks, cocktails, - Drinks with a low percentage of alcohol (for example low alcohol level beer or ‘alco-pop’) - (Other alcoholic beverages)

Data type

boolean

Alias
UMLS CUI [1]
C0001948
During the last six months, have you ever had 6 or more glasses (possible different) alcoholic beverages in one day?
Description

alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
During the last six months, how often have you had 6 or more (possible different) alcoholic beverages in one day?
Description

daily alcoholic beverages

Data type

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0332173
Do you usually drink alcoholic beverages during the days of the week (Monday till Thursday)?
Description

If your answer is no, please go to question "During how many days of the weekend (Friday till Sunday) do you usually drink alcoholic beverages?"

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0585023
During how many days of the week (Monday till Thursday) do you usually drink alcoholic beverages?
Description

alcohol consumption days of the week

Data type

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0585023
How many glasses on average do you drink during weekdays (Monday till Thursday) ?
Description

drinks per day

Data type

integer

Alias
UMLS CUI [1,1]
C0551555
UMLS CUI [1,2]
C0680189
Do you usually drink alcoholic beverages during weekend (Friday till Sunday)?
Description

alcohol consumption weekend

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0680190
During how many days of the weekend (Friday till Sunday) do you usually drink alcoholic beverages?
Description

alcohol consumption weekend

Data type

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0680190
How many glasses on average do you drink during the days of the weekend (Friday till Sunday) ?
Description

drinks per day weekend

Data type

integer

Alias
UMLS CUI [1,1]
C0551555
UMLS CUI [1,2]
C0556334
Have you ever felt the need to cut down on your drinking ?
Description

need to cut down drinking

Data type

boolean

Alias
UMLS CUI [1,1]
C3161943
UMLS CUI [1,2]
C0686904
Have you ever felt annoyed by criticism of your drinking ?
Description

annoyed by criticism of your drinking

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0870379
UMLS CUI [1,3]
C3843165
Have you ever felt guilty about drinking ?
Description

guilty about drinking

Data type

boolean

Alias
UMLS CUI [1]
C2199077
Did you ever take a morning eye opener?
Description

morning drinking

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0683352
Medical history and medical condition at study start (including medical history and chronic diseases)
Description

Medical history and medical condition at study start (including medical history and chronic diseases)

Alias
UMLS CUI-1
C0262926
Are you aware of any past disease prior to the study start or any ongoing chronic disease at the time of study start?
Description

If yes, please record it below.

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0332152
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0549178
Disease
Description

Disease

Alias
UMLS CUI-1
C0012634
name of disease
Description

Disease

Data type

text

Alias
UMLS CUI [1]
C0012634
Past
Description

disease in the past

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332119
Current
Description

Ongoing disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0549178
UMLS CUI [1,2]
C0012634
Start date
Description

Start date of disease

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0808070
Requiring medication?
Description

If 'yes', please complete the medication section.

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332121
Urine sample (Pregnancy test – HCG)
Description

Urine sample (Pregnancy test – HCG)

Alias
UMLS CUI-1
C0200354
Has a urine sample been taken?
Description

Urine sample pregnancy dipstick

Data type

integer

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C1880076
Date of urine sample
Description

Please complete only if different from visit date.

Data type

date

Alias
UMLS CUI [1,1]
C2371162
UMLS CUI [1,2]
C0011008
Result
Description

Result of pregnancy dipstick

Data type

integer

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0427777
Pre-vaccination assessment
Description

Pre-vaccination assessment

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0005903
UMLS CUI-3
C0042196
Temperature
Description

Temperature

Data type

float

Measurement units
  • degree Celsius
Alias
UMLS CUI [1]
C0005903
degree Celsius
Route
Description

Route of temperature measurement

Data type

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Vaccine administration - Twinrix group
Description

Vaccine administration - Twinrix group

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0593953
Date of vaccination
Description

Please complete only if different from visit date.

Data type

date

Alias
UMLS CUI [1,1]
C1115436
UMLS CUI [1,2]
C0593953
Vaccine administration
Description

Vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0593953
Has the study vaccine been administered according to protocol?
Description

Administration according to Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0593953
Side
Description

Side of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C0593953
Site
Description

Anatomic site of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0593953
Route
Description

Route of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0449444
UMLS CUI [1,3]
C0593953
Comments
Description

Comments vaccine administration

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0593953
Vaccine administration - Engerix-B and Havrix group
Description

Vaccine administration - Engerix-B and Havrix group

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0116078
UMLS CUI-3
C0700881
Date of vaccination
Description

Please complete only if different from visit date.

Data type

date

Alias
UMLS CUI [1,1]
C1115436
UMLS CUI [1,2]
C0700881
UMLS CUI [1,3]
C0116078
Vaccine administration
Description

Vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0116078
Has the study vaccine been administered according to protocol?
Description

Left Deltoid I.M.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0116078
Side
Description

Side of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C0116078
Site
Description

Anatomic site of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0116078
Route
Description

Route of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0449444
UMLS CUI [1,3]
C0116078
Vaccine administration
Description

Vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0700881
Has the study vaccine been administered according to protocol?
Description

Right Deltoid I.M.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0700881
Side
Description

Side of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C0700881
Site
Description

Anatomic site of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0700881
Route
Description

Route of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0449444
UMLS CUI [1,3]
C0700881
Comments
Description

Comments vaccine administration

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0116078
UMLS CUI [1,4]
C0700881
Vaccine administration - Hbvaxpro and Vaqta group
Description

Vaccine administration - Hbvaxpro and Vaqta group

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0379473
UMLS CUI-3
C1445761
Date of vaccination
Description

Please complete only if different from visit date.

Data type

date

Alias
UMLS CUI [1,1]
C1115436
UMLS CUI [1,2]
C0379473
UMLS CUI [1,3]
C1445761
Vaccine administration
Description

Vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1445761
Has the study vaccine been administered according to protocol?
Description

Left Deltoid I.M.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C1445761
Side
Description

Side of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C1445761
Site
Description

Anatomic site of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1445761
Route
Description

Route of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0449444
UMLS CUI [1,3]
C1445761
Vaccine administration
Description

Vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0379473
Has the study vaccine been administered according to protocol?
Description

Right Deltoid I.M.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0379473
Side
Description

Side of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C0379473
Site
Description

Anatomic site of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0379473
Route
Description

Route of vaccine administration

Data type

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0449444
UMLS CUI [1,3]
C0379473
Comments
Description

Comments vaccine administration

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0379473
UMLS CUI [1,4]
C1445761
Vaccine administration - Vaccination 1
Description

Vaccine administration - Vaccination 1

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0474232
Why not administered?
Description

Please tick the ONE most appropriate category for non administration.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0566251
Please specify SAE N°
Description

Number of SAE

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Other, please specify
Description

e.g.: consent withdrawal, Protocol violation, ...

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Please tick who took the decision
Description

decision taker

Data type

integer

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C2368628
Serious adverse event - Post-vaccination observation
Description

Serious adverse event - Post-vaccination observation

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2368628
UMLS CUI-3
C0687676
Has the subject experienced any serious adverse events within one month (minimum 30 days) post- vaccination?
Description

IMMEDIATE POST-VACCINATION OBSERVATION If any serious adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Serious Adverse Event form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
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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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
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])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Laboratory tests
C0022885 (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])
Item Group
Eligibility check
C0013893 (UMLS CUI-1)
meet entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion criteria
C1512693 (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])
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])
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])
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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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])
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])
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])
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])
Item Group
Smoking history
C1519384 (UMLS CUI-1)
Item
Do you smoke?
integer
C3241966 (UMLS CUI [1])
smoking
Code List
Do you smoke?
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])
cigarettes per day
Code List
How many cigarettes do you usually smoke on average each day?
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])
cigars per day
Code List
How many cigars do you usually smoke on average per day?
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])
Item
How much pipe tobacco do you smoke on average per week ?
integer
C0459842 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
pipe tobacco per week
Code List
How much pipe tobacco do you smoke on average per week ?
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])
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])
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])
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])
Smoking behaviour
Code List
Have you ever smoked?
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])
stop smoking duration
Code List
How long ago did you stop smoking?
CL Item
Less than two years ago (1)
CL Item
Two years ago or longer (2)
Item Group
Alcohol consumption questionnaire
C0001948 (UMLS CUI-1)
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])
alcohol consumption
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])
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])
undefined item
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])
drinks per day
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])
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])
undefined item
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])
undefined item
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])
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])
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])
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])
Item Group
Disease
C0012634 (UMLS CUI-1)
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])
Ongoing disease
Item
Current
boolean
C0549178 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Start date of disease
Item
Start date
date
C0012634 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Disease requires medication
Item
Requiring medication?
boolean
C0012634 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Item Group
Urine sample (Pregnancy test – HCG)
C0200354 (UMLS CUI-1)
Item
Has a urine sample been taken?
integer
C0200354 (UMLS CUI [1,1])
C1880076 (UMLS CUI [1,2])
Urine sample
Code List
Has a urine sample been taken?
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])
Item
Result
integer
C0430056 (UMLS CUI [1,1])
C0427777 (UMLS CUI [1,2])
Result of pregnancy dipstick
Code List
Result
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)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Route of temperature measurement
Code List
Route
CL Item
Axillary (A)
CL Item
Oral (O)
Item Group
Vaccine administration - Twinrix group
C2368628 (UMLS CUI-1)
C0593953 (UMLS CUI-2)
Date of vaccination
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
Vaccine administration
Code List
Vaccine administration
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])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
Side of vaccine administration
Code List
Side
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])
Anatomic site of vaccine administration
Code List
Site
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])
Route of vaccine administration
Code List
Route
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])
Item Group
Vaccine administration - Engerix-B and Havrix group
C2368628 (UMLS CUI-1)
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])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0116078 (UMLS CUI [1,2])
Vaccine administration
Code List
Vaccine administration
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])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
Side of vaccine administration
Code List
Side
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])
Anatomic site of vaccine administration
Code List
Site
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])
Route of vaccine administration
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0700881 (UMLS CUI [1,2])
Vaccine administration
Code List
Vaccine administration
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])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
Side of vaccine administration
Code List
Side
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])
Anatomic site of vaccine administration
Code List
Site
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])
Route of vaccine administration
Code List
Route
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])
Item Group
Vaccine administration - Hbvaxpro and Vaqta group
C2368628 (UMLS CUI-1)
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])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C1445761 (UMLS CUI [1,2])
Vaccine administration
Code List
Vaccine administration
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])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
Side of vaccine administration
Code List
Side
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])
Anatomic site of vaccine administration
Code List
Site
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])
Route of vaccine administration
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0379473 (UMLS CUI [1,2])
Vaccine administration
Code List
Vaccine administration
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])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
Side of vaccine administration
Code List
Side
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])
Anatomic site of vaccine administration
Code List
Site
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])
Route of vaccine administration
Code List
Route
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])
Item Group
Vaccine administration - Vaccination 1
C2368628 (UMLS CUI-1)
C0474232 (UMLS CUI-2)
Item
Why not administered?
text
C2368628 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
vaccine administration
Code List
Why not administered?
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])
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])
Item
Please tick who took the decision
integer
C0679006 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
decision taker
Code List
Please tick who took the decision
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)
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])
undefined item
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)
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