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])
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])