ID

33223

Beskrivning

Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination; ODM derived from: https://clinicaltrials.gov/show/NCT00684671

Länk

https://clinicaltrials.gov/show/NCT00684671

Nyckelord

Versioner (1)
  1. 2018-12-02 2018-12-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 december 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Viral Hepatitis Vaccines NCT00684671

Engelsk

Eligibility Viral Hepatitis Vaccines NCT00684671

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who the investigator believes that they can and will comply with the requirements of the protocol.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
a male or female who completed the primary vaccination phase of the hab-160 study (nct 00603252).
Beskrivning

Gender | Vaccination Phase Completed | Clinical Trial Specified

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C1710475
UMLS CUI [2,3]
C0205197
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0205369
written informed consent obtained from the subject.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
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 the vaccination.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0021361
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0427780
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
the following criteria should be checked at the time of study entry. if any apply, the subject must not be included in the study:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, or planned use during the study period.
Beskrivning

Investigational New Drugs | Drugs, Non-Prescription | INVESTIGATIONAL VACCINES | Exception Study Vaccine

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3]
C1875384
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2603343
UMLS CUI [4,3]
C0042210
history of any hepatitis a or hepatitis b vaccination or infection since the primary vaccination study.
Beskrivning

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

Datatyp

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.
Beskrivning

Hypersensitivity | Allergic Reaction Exacerbated Probably | Etiology Vaccine Component

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1444749
UMLS CUI [2,3]
C0750492
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0042210
UMLS CUI [3,3]
C1705248
acute disease at the time of enrolment.
Beskrivning

Acute Disease

Datatyp

boolean

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

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Viral Hepatitis Vaccines NCT00684671

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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.
boolean
C0525058 (UMLS CUI [1])
Gender | Vaccination Phase Completed | Clinical Trial Specified
Item
a male or female who completed the primary vaccination phase of the hab-160 study (nct 00603252).
boolean
C0079399 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C1710475 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0008976 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
Informed Consent
Item
written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Female infertility | 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 the vaccination.
boolean
C0021361 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0427780 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
the following criteria should be checked at the time of study entry. if any apply, the subject must not be included in the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Investigational New Drugs | Drugs, Non-Prescription | INVESTIGATIONAL VACCINES | Exception Study Vaccine
Item
use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, or planned use during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C1875384 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C2603343 (UMLS CUI [4,2])
C0042210 (UMLS CUI [4,3])
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.
boolean
C0419735 (UMLS CUI [1])
C0474232 (UMLS CUI [2])
C0019159 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
Hypersensitivity | Allergic Reaction Exacerbated Probably | Etiology Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C0750492 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
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])
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