ID

17488

Description

Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc; ODM derived from: https://clinicaltrials.gov/show/NCT00289731

Link

https://clinicaltrials.gov/show/NCT00289731

Keywords

Versions (1)
  1. 9/18/16 9/18/16 -
Uploaded on

September 18, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00289731

English

Eligibility Hepatitis B NCT00289731

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
healthy and non-healthy male or female aged 41 years or older at the time of the first vaccination.
Description

Age | Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1708335
written informed consent obtained from the subject.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
no serological signs of hepatitis a or b infection at screening.
Description

Hepatitis A Signs Serologic | Hepatitis B Signs Serologic

Data type

boolean

Alias
UMLS CUI [1,1]
C0019159
UMLS CUI [1,2]
C0311392
UMLS CUI [1,3]
C0205473
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0311392
UMLS CUI [2,3]
C0205473
if the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions 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

Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0036899
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
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

Investigational New Drugs | Drugs, Non-Prescription | Vaccines Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C1517586
history of any hepatitis a or hepatitis b vaccination or infection, since the primary vaccination study 100382.
Description

Hepatitis A immunization | Hepatitis B vaccination | Hepatitis A | Hepatitis B

Data type

boolean

Alias
UMLS CUI [1]
C0419735
UMLS CUI [2]
C0474232
UMLS CUI [3]
C0019159
UMLS CUI [4]
C0019163
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Description

Hypersensitivity Exacerbated Due to Vaccine Component | Allergic Reaction Exacerbated Due to Vaccine Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1444749
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0042210
UMLS CUI [1,5]
C1705248
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1444749
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0042210
UMLS CUI [2,5]
C1705248
acute disease at the time of enrolment. .
Description

Acute Disease

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period.
Description

Gender | Pregnancy, Planned | Contraceptive methods Discontinuation Planned

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0032992
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1301732
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Similar models

Eligibility Hepatitis B NCT00289731

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Protocol Compliance
Item
subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
boolean
C0525058 (UMLS CUI [1])
Age | Healthy Volunteers
Item
healthy and non-healthy male or female aged 41 years or older at the time of the first vaccination.
boolean
C0001779 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
Informed Consent
Item
written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Hepatitis A Signs Serologic | Hepatitis B Signs Serologic
Item
no serological signs of hepatitis a or b infection at screening.
boolean
C0019159 (UMLS CUI [1,1])
C0311392 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
C0019163 (UMLS CUI [2,1])
C0311392 (UMLS CUI [2,2])
C0205473 (UMLS CUI [2,3])
Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy test negative
Item
if the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions 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
C3831118 (UMLS CUI [1,1])
C0036899 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Drugs, Non-Prescription | Vaccines Investigational
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
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042210 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
Hepatitis A immunization | Hepatitis B vaccination | Hepatitis A | Hepatitis B
Item
history of any hepatitis a or hepatitis b vaccination or infection, since the primary vaccination study 100382.
boolean
C0419735 (UMLS CUI [1])
C0474232 (UMLS CUI [2])
C0019159 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
Hypersensitivity Exacerbated Due to Vaccine Component | Allergic Reaction Exacerbated Due to Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
C1705248 (UMLS CUI [1,5])
C1527304 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0042210 (UMLS CUI [2,4])
C1705248 (UMLS CUI [2,5])
Acute Disease
Item
acute disease at the time of enrolment. .
boolean
C0001314 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender | Pregnancy, Planned | Contraceptive methods Discontinuation Planned
Item
female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period.
boolean
C0079399 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
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