Informed Consent obtained
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
C0021430 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Previous studies
integer
C2242969 (UMLS CUI [1])
Code List
Previous studies
CL Item
759346/004 (DTPwHB/HibMenAC-TT-004) (1)
CL Item
100791 (DTPW-HBV=HIB-MENAC-TT-013) (2)
Subject number of previous study
Item
Enter subject number of previous study.
integer
C2242969 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Parents/ guardians can and will comply with the requirements of the protocol
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
C1321605 (UMLS CUI [1,1])
C1709747 (UMLS CUI [1,2])
C3176968 (UMLS CUI [2])
C1522577 (UMLS CUI [3])
C4041024 (UMLS CUI [4])
Age at the time of vaccination
Item
A male or female between, and including: 15 and 18 months of age (i.e. as of 14 months +1 day until 19 months -1 day of age or 427 to 577 days old) at the time of vaccination in the Phillipines; 15 to 24 months of age (until 23 months +30days of age or 427 to 730 days old) at the time of vaccination in Thailand.
boolean
C0001779 (UMLS CUI [1])
Written informed consent
Item
Written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1])
C0030551 (UMLS CUI [2])
C0023226 (UMLS CUI [3])
Health problems established by medical history and clinical examination
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C1446390 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C1456356 (UMLS CUI [3])
Primary vaccination safety study
Item
Having participated in the primary vaccination safety study DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or safety study DTPW-HBV=HIB-MENAC-TT-013 (e Track No. 100791).
boolean
C2348568 (UMLS CUI [1])
Investigational or non- registered product use other than the study vaccine
Item
Use of any investigational or non- registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
boolean
C0242510 (UMLS CUI [1])
C0042210 (UMLS CUI [2])
Chronic administration of immunosuppresants or other immune- modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppresants or other immune- modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone, or equivalent , >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021083 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0449238 (UMLS CUI [2])
C0042196 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C0032952 (UMLS CUI [5])
Planned administration/ administration of a vaccine
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
boolean
C1533734 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2])
Booster vaccination against diphteria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/ or meningococcal serogroups A and C disease
Item
Booster vaccination against diphteria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/ or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (e Track No. 100791).
boolean
C0419731 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C0012546 (UMLS CUI [2,2])
C0042196 (UMLS CUI [3,1])
C0039614 (UMLS CUI [3,2])
C0042196 (UMLS CUI [4,1])
C0043167 (UMLS CUI [4,2])
C0042196 (UMLS CUI [5,1])
C0121772 (UMLS CUI [5,2])
C0042196 (UMLS CUI [6,1])
C0025303 (UMLS CUI [6,2])
History of diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease.
Item
History of diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease.
boolean
C0012546 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0039614 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0043167 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
C0025303 (UMLS CUI [5,1])
C0262926 (UMLS CUI [5,2])
Known exposure to diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease
Item
Known exposure to diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease.
boolean
C0012546 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0039614 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0043167 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4,1])
C0332157 (UMLS CUI [4,2])
C0025303 (UMLS CUI [5,1])
C0332157 (UMLS CUI [5,2])
Any confirmed or suspected immunosuppresive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
Item
Any confirmed or suspected immunosuppresive or immunodeficient condition, including human immunodeficiency virus (HIV) infection (no laboratory testing required).
boolean
C3829792 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0019682 (UMLS CUI [2])
A 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])
C0439660 (UMLS CUI [1,3])
C0021051 (UMLS CUI [1,4])
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C2106654 (UMLS CUI [1])
C0235874 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
Major congenital defects or serious chronic illness
Item
Major congenital defects or serious chronic illness.
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [1,3])
C0205404 (UMLS CUI [1,4])
History of any neurologic disorders or seizures including febrile seizures in infancy
Item
History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.
boolean
C0027765 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0009952 (UMLS CUI [2])
C0231330 (UMLS CUI [3])
Acute disease at the time of enrolment
Item
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low- grade febrile illness, i. e. axillary temperature <37.5.°C).
boolean
C0001314 (UMLS CUI [1,1])
C4041024 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0221423 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
C0332281 (UMLS CUI [2,5])
C0015967 (UMLS CUI [2,6])
C2368628 (UMLS CUI [3])
C0205165 (UMLS CUI [4])
C0011991 (UMLS CUI [5])
C0041912 (UMLS CUI [6,1])
C2945599 (UMLS CUI [6,2])
Administration of immunoglobulins and/ or any blood products
Item
Administration of immunoglobulins and/ or any blood products within the three months preceding the vaccination or planned administration during the study period.
boolean
C1533734 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C1533734 (UMLS CUI [2,1])
C0456388 (UMLS CUI [2,2])
C0042196 (UMLS CUI [3])
C1533734 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])