ID

29592

Beschreibung

Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults; ODM derived from: https://clinicaltrials.gov/show/NCT00603252

Link

https://clinicaltrials.gov/show/NCT00603252

Stichworte

Versionen (1)
  1. 09.04.18 09.04.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. April 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT00603252

Englisch

Eligibility Hepatitis B NCT00603252

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
a male or female who completed the primary vaccination phase of the study.
Beschreibung

Vaccination Primary Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0205197
written informed consent obtained from the subject.
Beschreibung

Informed Consent

Datentyp

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 completion of the vaccination series.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0036899
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0427780
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2348563
UMLS CUI [3,3]
C0042210
history of any hepatitis a or hepatitis b vaccination or infection, since the primary vaccination study.
Beschreibung

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

Datentyp

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.
Beschreibung

Hypersensitivity Exacerbated | Allergic Reaction Exacerbated | Etiology Vaccine Component

Datentyp

boolean

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

Acute Disease

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Hepatitis B NCT00603252

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Vaccination Primary Completed
Item
a male or female who completed the primary vaccination phase of the study.
boolean
C0042196 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Gender | Childbearing Potential Absent | 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
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0427780 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Drugs, Non-Prescription | Exception Study Protocol Vaccines
Item
use of any investigational or non-registered product 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])
C1705847 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
C0042210 (UMLS CUI [3,3])
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 Exacerbated | Allergic Reaction Exacerbated | Etiology Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
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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