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)
  1. 2017-09-09 2017-09-09 -
  2. 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

Engelsk

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 Formulär  
Informed consent
Beskrivning

Informed consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Beskrivning

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

Datatyp

date

Alias
UMLS CUI [1]
C2985782
Demographics
Beskrivning

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Beskrivning

Center number

Datatyp

text

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

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beskrivning

Gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beskrivning

Race

Datatyp

text

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

If you chose 'Other Race', please specify

Datatyp

text

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

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Laboratory tests
Beskrivning

Laboratory tests

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

Blood sample

Datatyp

boolean

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

Please complete only if different from visit date

Datatyp

boolean

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

Eligibility check

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

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.

Datatyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Beskrivning

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.
Beskrivning

Compliance

Datatyp

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.
Beskrivning

age at first vaccination

Datatyp

boolean

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

Informed consent

Datatyp

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.
Beskrivning

health status

Datatyp

boolean

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

Seronegative Hepatitis A and B

Datatyp

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.
Beskrivning

child-bearing potential contraception

Datatyp

boolean

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

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.
Beskrivning

Use of any investigational or non-registered product

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

History of allergic diseases or reactions

Datatyp

boolean

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

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]

Datatyp

boolean

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

Pregnant or lactating female

Datatyp

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).
Beskrivning

planning pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032992
Smoking history
Beskrivning

Smoking history

Alias
UMLS CUI-1
C1519384
Do you smoke?
Beskrivning

smoking

Datatyp

integer

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

cigarettes per day

Datatyp

integer

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

cigars per day

Datatyp

integer

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

Only answer, if you smoke cigars.

Datatyp

integer

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

pipe tobacco per week

Datatyp

integer

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

amount of weekly pipe tobacco

Datatyp

integer

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

age start smoking

Datatyp

integer

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

reduced smoking

Datatyp

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?
Beskrivning

increased smoking

Datatyp

boolean

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

ever tried stop smoking

Datatyp

boolean

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

Smoking behaviour

Datatyp

integer

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

stop smoking duration

Datatyp

integer

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

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)?
Beskrivning

- 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)

Datatyp

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?
Beskrivning

alcohol consumption

Datatyp

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?
Beskrivning

daily alcoholic beverages

Datatyp

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)?
Beskrivning

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?"

Datatyp

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?
Beskrivning

alcohol consumption days of the week

Datatyp

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) ?
Beskrivning

drinks per day

Datatyp

integer

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

alcohol consumption weekend

Datatyp

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?
Beskrivning

alcohol consumption weekend

Datatyp

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) ?
Beskrivning

drinks per day weekend

Datatyp

integer

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

need to cut down drinking

Datatyp

boolean

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

annoyed by criticism of your drinking

Datatyp

boolean

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

guilty about drinking

Datatyp

boolean

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

morning drinking

Datatyp

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)
Beskrivning

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?
Beskrivning

If yes, please record it below.

Datatyp

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
Beskrivning

Disease

Alias
UMLS CUI-1
C0012634
name of disease
Beskrivning

Disease

Datatyp

text

Alias
UMLS CUI [1]
C0012634
Past
Beskrivning

disease in the past

Datatyp

boolean

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

Ongoing disease

Datatyp

boolean

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

Start date of disease

Datatyp

date

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

If 'yes', please complete the medication section.

Datatyp

boolean

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

Urine sample (Pregnancy test – HCG)

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

Urine sample pregnancy dipstick

Datatyp

integer

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

Please complete only if different from visit date.

Datatyp

date

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

Result of pregnancy dipstick

Datatyp

integer

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

Pre-vaccination assessment

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

Temperature

Datatyp

float

Måttenheter
  • degree Celsius
Alias
UMLS CUI [1]
C0005903
degree Celsius
Route
Beskrivning

Route of temperature measurement

Datatyp

text

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

Vaccine administration - Twinrix group

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

Please complete only if different from visit date.

Datatyp

date

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

Vaccine administration

Datatyp

integer

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

Administration according to Protocol

Datatyp

boolean

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

Side of vaccine administration

Datatyp

integer

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

Anatomic site of vaccine administration

Datatyp

integer

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

Route of vaccine administration

Datatyp

integer

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

Comments vaccine administration

Datatyp

text

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

Vaccine administration - Engerix-B and Havrix group

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

Please complete only if different from visit date.

Datatyp

date

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

Vaccine administration

Datatyp

integer

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

Left Deltoid I.M.

Datatyp

boolean

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

Side of vaccine administration

Datatyp

integer

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

Anatomic site of vaccine administration

Datatyp

integer

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

Route of vaccine administration

Datatyp

integer

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

Vaccine administration

Datatyp

integer

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

Right Deltoid I.M.

Datatyp

boolean

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

Side of vaccine administration

Datatyp

integer

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

Anatomic site of vaccine administration

Datatyp

integer

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

Route of vaccine administration

Datatyp

integer

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

Comments vaccine administration

Datatyp

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
Beskrivning

Vaccine administration - Hbvaxpro and Vaqta group

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

Please complete only if different from visit date.

Datatyp

date

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

Vaccine administration

Datatyp

integer

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

Left Deltoid I.M.

Datatyp

boolean

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

Side of vaccine administration

Datatyp

integer

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

Anatomic site of vaccine administration

Datatyp

integer

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

Route of vaccine administration

Datatyp

integer

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

Vaccine administration

Datatyp

integer

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

Right Deltoid I.M.

Datatyp

boolean

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

Side of vaccine administration

Datatyp

integer

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

Anatomic site of vaccine administration

Datatyp

integer

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

Route of vaccine administration

Datatyp

integer

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

Comments vaccine administration

Datatyp

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
Beskrivning

Vaccine administration - Vaccination 1

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

Please tick the ONE most appropriate category for non administration.

Datatyp

text

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

Number of SAE

Datatyp

integer

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

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

Datatyp

text

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

decision taker

Datatyp

integer

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

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?
Beskrivning

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.

Datatyp

text

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

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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