ID

29589

Descrição

Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule; ODM derived from: https://clinicaltrials.gov/show/NCT00480116

Link

https://clinicaltrials.gov/show/NCT00480116

Palavras-chave

Versões (1)
  1. 08/04/2018 08/04/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 de abril de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00480116

Inglês

Eligibility Hepatitis B NCT00480116

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
a healthy male or female adult aged between 18 and 40 years.
Descrição

Healthy adult | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0686750
UMLS CUI [2]
C0001779
written informed consent obtained from the subject
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Descrição

Investigational New Drugs | Drugs, Non-Prescription | Vaccines Investigational | Vaccines Non-Prescription Drugs | Exception Study Protocol Vaccines

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C1517586
UMLS CUI [4,1]
C0042210
UMLS CUI [4,2]
C0013231
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2348563
UMLS CUI [5,3]
C0042210
chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Descrição

Immunosuppressive Agents chronic | Biological Response Modifiers chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose.
Descrição

Vaccines | Exception Study Protocol Vaccines | Vaccines, Inactivated | Vaccines, Attenuated

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0042210
UMLS CUI [3]
C0042212
UMLS CUI [4]
C0042211
concurrently participating in another clinical study or exposure to an investigational or a non-investigational product (pharmaceutical product or device).
Descrição

Study Subject Participation Status | Exposure to Investigational New Drugs | Exposure to Investigational Medical Device | Exposure to Pharmaceutical Preparations | Exposure to Medical Device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C2346570
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C0013227
UMLS CUI [5,1]
C0332157
UMLS CUI [5,2]
C0025080
history of hepatitis b infection.
Descrição

Hepatitis B

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
known exposure to hepatitis b virus within 6 months.
Descrição

Exposure to Hepatitis B Virus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0019169
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Descrição

Immunosuppression Medical History | Immunosuppression Suspected Medical History | Immunodeficiency Medical History | Immunodeficiency Suspected Medical History | Immunosuppression Clinical examination | Immunosuppression Suspected Clinical examination | Immunodeficiency Clinical examination | Immunodeficiency Suspected Clinical examination

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0262926
UMLS CUI [3,1]
C0021051
UMLS CUI [3,2]
C0262926
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0262926
UMLS CUI [5,1]
C4048329
UMLS CUI [5,2]
C1456356
UMLS CUI [6,1]
C4048329
UMLS CUI [6,2]
C0750491
UMLS CUI [6,3]
C1456356
UMLS CUI [7,1]
C0021051
UMLS CUI [7,2]
C1456356
UMLS CUI [8,1]
C0021051
UMLS CUI [8,2]
C0750491
UMLS CUI [8,3]
C1456356
pregnant or lactating female.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
female planning to become pregnant or planning to discontinue contraceptive precautions.
Descrição

Pregnancy, Planned | Contraceptive methods Discontinue Planned

Tipo de dados

boolean

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

Eligibility Hepatitis B NCT00480116

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Healthy adult | Age
Item
a healthy male or female adult aged between 18 and 40 years.
boolean
C0686750 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
written informed consent obtained from the subject
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Drugs, Non-Prescription | Vaccines Investigational | Vaccines Non-Prescription Drugs | Exception Study Protocol Vaccines
Item
use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) 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])
C0042210 (UMLS CUI [4,1])
C0013231 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C2348563 (UMLS CUI [5,2])
C0042210 (UMLS CUI [5,3])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic
Item
chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Vaccines | Exception Study Protocol Vaccines | Vaccines, Inactivated | Vaccines, Attenuated
Item
administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose.
boolean
C0042210 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C0042212 (UMLS CUI [3])
C0042211 (UMLS CUI [4])
Study Subject Participation Status | Exposure to Investigational New Drugs | Exposure to Investigational Medical Device | Exposure to Pharmaceutical Preparations | Exposure to Medical Device
Item
concurrently participating in another clinical study or exposure to an investigational or a non-investigational product (pharmaceutical product or device).
boolean
C2348568 (UMLS CUI [1])
C0332157 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C2346570 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0332157 (UMLS CUI [5,1])
C0025080 (UMLS CUI [5,2])
Hepatitis B
Item
history of hepatitis b infection.
boolean
C0019163 (UMLS CUI [1])
Exposure to Hepatitis B Virus
Item
known exposure to hepatitis b virus within 6 months.
boolean
C0332157 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
Immunosuppression Medical History | Immunosuppression Suspected Medical History | Immunodeficiency Medical History | Immunodeficiency Suspected Medical History | Immunosuppression Clinical examination | Immunosuppression Suspected Clinical examination | Immunodeficiency Clinical examination | Immunodeficiency Suspected Clinical examination
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
boolean
C4048329 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C4048329 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C0021051 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0262926 (UMLS CUI [4,3])
C4048329 (UMLS CUI [5,1])
C1456356 (UMLS CUI [5,2])
C4048329 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
C1456356 (UMLS CUI [6,3])
C0021051 (UMLS CUI [7,1])
C1456356 (UMLS CUI [7,2])
C0021051 (UMLS CUI [8,1])
C0750491 (UMLS CUI [8,2])
C1456356 (UMLS CUI [8,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy, Planned | Contraceptive methods Discontinue Planned
Item
female planning to become pregnant or planning to discontinue contraceptive precautions.
boolean
C0032992 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
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