Subject met all entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Parents Protocol Compliance
Item
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
Gender, Age
Item
A male or female child between, and including, 5 and 10 weeks of age at the time of the first study vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C0021270 (UMLS CUI [2,2])
Informed Consent Guardian or parents
Item
Written informed consent obtained from the parent or guardian of the subject
boolean
C0021430 (UMLS CUI [1,1])
C1274041 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
Subject Healthy
Item
Healthy subjects as established by medical history and clinical examination before entering into the study.
boolean
C3898900 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Birth weight
Item
Birth weight > 2000 g.
boolean
C0005612 (UMLS CUI [1])
Use of investigational drug or vaccine
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])
C0013230 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C1521826 (UMLS CUI [3,2])
C0042210 (UMLS CUI [3,3])
Concurrently participating in another clinical study with exposure to investigational drug
Item
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Planned administration of other vaccine
Item
Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after.
boolean
C2368628 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Chronic administration of immunosuppressants except topical steroids
Item
Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0038317 (UMLS CUI [2,2])
C1522168 (UMLS CUI [2,3])
History of use of experimental rotavirus vaccine
Item
History of use of experimental rotavirus vaccine.
boolean
C0262926 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
Previous routine vaccination except BCG, HBV and OPV
Item
Previous routine vaccination except BCG, HBV and OPV vaccination at birth (should be documented in the eCRF).
boolean
C0042210 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0004886 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0474232 (UMLS CUI [3,2])
C0332300 (UMLS CUI [4,1])
C0032375 (UMLS CUI [4,2])
History of gastrointestinal disease
Item
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator
boolean
C0017178 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0017189 (UMLS CUI [2,1])
C0000768 (UMLS CUI [2,2])
C0021933 (UMLS CUI [3])
C0009488 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Immunodeficient condition based on medical history or physical examination
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
boolean
C4048329 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C4048329 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
History of allergic disease
Item
History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
boolean
C2106654 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Acute disease moderate or severe
Item
Acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0001314 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Recent Gastroenteritis
Item
Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination).
boolean
C0017160 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent Rotavirus Gastroenteritis
Item
Previous confirmed occurrence of RV GE.
boolean
C0262926 (UMLS CUI [1,1])
C0035870 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0017160 (UMLS CUI [2,2])
Family history of congenital or hereditary immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0241889 (UMLS CUI [1,1])
C0853602 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0021051 (UMLS CUI [2,2])
C0439660 (UMLS CUI [2,3])
History of or planned administration of immunoglobulins or blood products
Item
Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
boolean
C0262926 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C1301732 (UMLS CUI [2,1])
C0021027 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0456388 (UMLS CUI [3,2])
C1301732 (UMLS CUI [4,1])
C0456388 (UMLS CUI [4,2])
History of neurologic disorders or seizures
Item
History of any neurologic disorders or seizures.
boolean
C0262926 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0036572 (UMLS CUI [2,2])
pulmonary, cardiovascular, hepatic or renal dysfunction
Item
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0587081 (UMLS CUI [6])