Enrollment Clinical Trial Preceding
Item
subjects must have been enrolled in the rota-028 study.
boolean
C1516879 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Protocol Compliance parent | Protocol Compliance Guardian
Item
subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Age
Item
a male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
boolean
C0001779 (UMLS CUI [1])
Informed Consent parent | Informed Consent Guardian
Item
written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Disease Free of | examination; clinical
Item
free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0012634 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C1456356 (UMLS CUI [2])
Hepatitis B vaccination Dosage Quantity
Item
subjects should have received two doses of hepatitis b vaccine: at birth and at approximately one month of age.
boolean
C0474232 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Immunosuppressive Agents Administration chronic | Biological Response Modifiers
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
boolean
C0021081 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0005525 (UMLS CUI [2])
Vaccine Illicit Study Protocol
Item
planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
boolean
C0042210 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Immunosuppression | Immunologic Deficiency Syndromes | HIV Infections
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Immunodeficiency congenital Family history | Immunodeficiency Hereditary Family history
Item
a family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0241889 (UMLS CUI [2,3])
History of allergies | history of allergic reaction | Exacerbation Probably Due to Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0489531 (UMLS CUI [1])
C2106654 (UMLS CUI [2])
C0235874 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0042210 (UMLS CUI [3,4])
C1705248 (UMLS CUI [3,5])
Congenital Abnormality Major | Chronic disease Serious
Item
major congenital defects or serious chronic illness.
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
nervous system disorder | Seizures
Item
history of any neurologic disorders or seizures.
boolean
C0027765 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Acute Disease
Item
acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
Immunoglobulins | Blood product | Immunoglobulins Administration Planned | Blood product Administration Planned
Item
administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0021027 (UMLS CUI [3,1])
C1533734 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
C0456388 (UMLS CUI [4,1])
C1533734 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])