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])
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])