Protocol
Item
Protocol
integer
C1507394 (UMLS CUI [1])
Case Report File
Item
CRF
text
C1516308 (UMLS CUI [1])
Visit
Item
Visit
text
C0545082 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Informed Consent
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
C2985782 (UMLS CUI [1])
Screening identification number
Item
Screening ID
integer
C1300638 (UMLS CUI [1])
Study center
Item
Study center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Previous Studies
integer
C2242969 (UMLS CUI [1])
Code List
Previous Studies
CL Item
208355/118 (APV-118) (1)
CL Item
208355/120 (APV-120) (2)
Subject number of previous study
Item
Subject number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Item
Race
integer
C0034510 (UMLS CUI [1])
CL Item
[4] Arabic/North African (2)
CL Item
[2] White/Caucasian (3)
CL Item
[5] East & South East Asian (4)
CL Item
[6] South Asian (5)
Other Race
Item
Other Race, please specify:
text
C0034510 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria? If No, please complete below
boolean
C1516637 (UMLS CUI [1])
Study subject participation status and Age
Item
Subjects previously enrolled and vaccinated in GSK Bio’s studies APV-118 and APV-120 and who are 9 through 13 years of age
boolean
C2348568 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Compliance behavior
Item
Subjects for whom the investigator believes the requirements of the protocol will be complied with (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study
boolean
C1321605 (UMLS CUI [1])
Informed consent
Item
Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Medical history and physical examination
Item
Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study.
boolean
C0262926 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Access to a telephone
Item
Subjects or subjects' parents/guardian have access to a telephone where they can be reached during the entire study period.
boolean
C1822200 (UMLS CUI [1])
Females of childbearing potential must have a negativ pregnancy test, must be abstinent or have used adequate contraceptive method
Item
Females of childbearing potential (i.e., who have reached menarche) at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and must be abstinent or have used adequate contraceptive precautions (i.e., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant®, DepoProvera®, contraceptive skin patch or cervical ring) for one month prior to vaccination. Subjects also must agree to continue such precautions for two months after vaccination.
boolean
C3831118 (UMLS CUI [1,1])
C0032976 (UMLS CUI [1,2])
C0036899 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
concomitant therapy with Investigational agents
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
boolean
C1707479 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1707479 (UMLS CUI [2,1])
C1875384 (UMLS CUI [2,2])
Administration of a vaccine
Item
Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study.
boolean
C1707479 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Concomitant therapy with vaccines
Item
Administration of a tetanus-toxoid, diphtheria-toxoid or pertussis-antigen containing vaccine since the last study visit in GSK Bio studies APV-118 or APV-120.
boolean
C1707479 (UMLS CUI [1,1])
C0039620 (UMLS CUI [1,2])
C1707479 (UMLS CUI [2,1])
C0199806 (UMLS CUI [2,2])
C1707479 (UMLS CUI [3,1])
C0031237 (UMLS CUI [3,2])
Medical History of allergic disease or adverse event of vaccines
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C1116172 (UMLS CUI [2,2])
History of previous vaccination against hepatitis A or history of hepatitis A infection
Item
History of previous vaccination against hepatitis A or history of hepatitis A infection.
boolean
C0262926 (UMLS CUI [1,1])
C0170300 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0019159 (UMLS CUI [2,2])
Hypersensitivity to any component of the vaccines
Item
Hypersensitivity to any component of the vaccines.
boolean
C0571550 (UMLS CUI [1])
History of anaphylactic or anaphylactic-like reaction temporally associated with a previous dose of DTP vaccine.
Item
History of anaphylactic or anaphylactic-like reaction temporally associated with a previous dose of DTP vaccine.
boolean
C0262926 (UMLS CUI [1,1])
C0002792 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C2220378 (UMLS CUI [2,2])
History of encephalopathy adverse event within seven days of administration of a previous dose of DTP vaccine
Item
History of encephalopathy within seven days of administration of a previous dose of DTP vaccine, defined as an acute, severe central nervous system disorder unexplained by another cause, occurring within seven days following vaccination and which may be manifested by major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours with failure to recover within 24 hours. Even though causation by DTP vaccine cannot be established, no subsequent doses of pertussis vaccine should be given.
boolean
C0262926 (UMLS CUI [1,1])
C1116172 (UMLS CUI [1,2])
C0085584 (UMLS CUI [1,3])
Convulsions in due of a previous dose of DTP vaccine
Item
History of convulsions (seizures) with or without fever occurring within 3 days of receipt of a previous dose of DTP vaccine.
boolean
C0262926 (UMLS CUI [1,1])
C0012559 (UMLS CUI [1,2])
C0413534 (UMLS CUI [1,3])
C0751494 (UMLS CUI [1,4])
Fever in due of a previous dose of DTP vaccine
Item
Temperature of >40.5oC within 48 hours of receipt of a previous dose of DTP vaccine, not due to another identifiable cause
boolean
C1116172 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Collapse or shock-like state in due of a previous dose of DTP vaccine
Item
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of receipt of a previous dose of DTP vaccine.
boolean
C1116172 (UMLS CUI [1,1])
C0036974 (UMLS CUI [1,2])
C1116172 (UMLS CUI [2,1])
C0549265 (UMLS CUI [2,2])
Persistent, severe, inconsolable screaming or crying in due of a previous dise of DTP vaccine
Item
Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine.
boolean
C1116172 (UMLS CUI [1,1])
C0012559 (UMLS CUI [1,2])
C0521008 (UMLS CUI [1,3])
C1116172 (UMLS CUI [2,1])
C0012559 (UMLS CUI [2,2])
C0010399 (UMLS CUI [2,3])
Progressive neurologic disorder
Item
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy: defer immunization until neurologic status is clarified and stabilized.
boolean
C0027765 (UMLS CUI [1,1])
C1280477 (UMLS CUI [1,2])
Thrombocytopenia or neurologic complications following an earlier immunization against either diphtheria and/or tetanus
Item
Previously experienced transient thrombocytopenia or neurologic complications following an earlier immunization against either diphtheria and/or tetanus
boolean
C1116172 (UMLS CUI [1,1])
C0058773 (UMLS CUI [1,2])
C0040034 (UMLS CUI [1,3])
C1116172 (UMLS CUI [2,1])
C0058773 (UMLS CUI [2,2])
C0235029 (UMLS CUI [2,3])
Acute disease at the time of vaccination
Item
Acute disease at the time of vaccination (Acute disease is defined as the presence of a moderate or severe illness with or without fever. Vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever, i.e., axillary temperature <37.5°C).
boolean
C0001314 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Pregnant or lactating
Item
Pregnant or lactating female or female who is anticipating becoming pregnant within two months after vaccination.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical history
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
C0262926 (UMLS CUI [1])
Item
Diagnosis body systems
integer
C0682591 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Code List
Diagnosis body systems
CL Item
Ears-nose-throat (3)
CL Item
Cardiovascular (4)
CL Item
Gastrointestinal (6)
CL Item
Muskuloskeletal (7)
CL Item
Genitourinary (9)
CL Item
Other (specify) (13)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Past or current diagnosis
integer
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
Code List
Past or current diagnosis
Baseline measurement of the length of upper arm to be injected
Item
Length of the upper arm (non-dominant) to be injected:
integer
C0426866 (UMLS CUI [1,1])
C0446516 (UMLS CUI [1,2])
Baseline measurement of mid upper arm circumference
Item
Circumference of the mid upper arm (non-dominant) to be injected:
integer
C0562351 (UMLS CUI [1])
Item
Dominant arm?
integer
C0023114 (UMLS CUI [1])
Blood sample taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Blood sample date
Item
Please complete only if different from visit date
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item
Has a urine sample been taken?
integer
C0200354 (UMLS CUI [1])
Code List
Has a urine sample been taken?
CL Item
NA (not of childbearing potential or male) (3)
Urin sample date
Item
Please complete only if different from visit date:
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
integer
C1274040 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item
Route
integer
C0013153 (UMLS CUI [1])
CL Item
Axillary (preferred) (1)
Vaccine administration date
Item
Please complete only if different from visit date:
date
C0011008 (UMLS CUI [1])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1])
Code List
Vaccine administration
CL Item
dTpa 0.3mg Vaccine or Havrix® Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
Item
Side / site route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Code List
Side / site route
Study vaccine been administered according to the Protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2599718 (UMLS CUI [1,2])
Item
Arm:
integer
C0023114 (UMLS CUI [1])
Item
Site:
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Item
Route:
integer
C0013153 (UMLS CUI [1])
Comments
Item
Comments:
text
C0947611 (UMLS CUI [1])
Item
category for non administration:
integer
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
category for non administration:
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event page) (2)
Serious adverse event
Item
Please specify SAE N°
integer
C1519255 (UMLS CUI [1])
Item
Please specify AE N°
integer
C1518404 (UMLS CUI [1])
Code List
Please specify AE N°
Non-serious adverse event, unsolicited
Item
Please specify AE N° (Unsol.):
integer
C1518404 (UMLS CUI [1])
Non-serious adverse event, solicited
Item
Please specify AE N° (Solicited)
integer
C1518404 (UMLS CUI [1])
Other events
Item
Other, please specify:
text
C0441471 (UMLS CUI [1])
Item
Who took the decision:
integer
C0679006 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1548562 (UMLS CUI [1,3])
Code List
Who took the decision:
CL Item
Parents/Guardians (2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
integer
C1519255 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not retrievable (1)
CL Item
No vaccine administered (2)
CL Item
Yes, fill in the non-serious adverse event pages or serious adverse event form. (4)
Item
Measurement
integer
C0242485 (UMLS CUI [1])
Mid upper arm circumference
Item
Circumference
integer
C0562351 (UMLS CUI [1])
Measurement of mid upper arm circumference continued
Item
Ongoing after Day 14?
boolean
C0242485 (UMLS CUI [1,1])
C0562351 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Redness
Item
Redness ( RE )
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Redness size (mm)
Item
Redness size (mm)
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ( SW )
Item
Swelling ( SW )
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Swelling size (mm)
Item
Swelling size (mm)
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Pain ( PA )
Item
Pain ( PA )
boolean
C0030193 (UMLS CUI [1])
Item
Pain intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Local symptoms ongoing after day 14
Item
Ongoing after day 14?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Medical advice
Item
Medical advice
boolean
C1386497 (UMLS CUI [1])
Item
Type
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item
General symptoms
integer
C0159028 (UMLS CUI [1])
Code List
General symptoms
Fever, diagnosis
Item
Fever, diagnosis
boolean
C0011900 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever, site of measurement
integer
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Code List
Fever, site of measurement
CL Item
Axillary (preferred) (1)
Fever (FE)
Item
Fever (FE)
float
C0015967 (UMLS CUI [1])
Fatigue (FA)
Item
Fatigue (FA)
boolean
C0015672 (UMLS CUI [1])
Item
Fatigue intensity
integer
C0015672 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Fatigue intensity
Headache (HE)
Item
Headache (HE)
boolean
C0018681 (UMLS CUI [1])
Item
Headache, intensity
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Headache, intensity
Gastrointestinal symptoms (GI)
Item
Gastrointestinal symptoms (GI)
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms, intensity
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Code List
Gastrointestinal symptoms, intensity
General symptoms ongoing after day 14
Item
Ongoing after day 14?
boolean
C0159028 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of Symptoms
Item
Date of last day of Symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
Medical advice
Item
Medical advice?
boolean
C1386497 (UMLS CUI [1])
Item
Type
integer
C0332307 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
CL Item
HO: Hospitalization (1)
CL Item
ER: Emergency room (2)
CL Item
MD: Medical doctor (3)
Telephone contact 1
Item
Have the subject's parent(s) / guardian(s) been contacted by telephone?
boolean
C0420309 (UMLS CUI [1])