Informações:
Falhas:
ID
36630
Descrição
Study ID: 102394 Clinical Study ID: 102394 Study Title: A Phase IV, partially double-blind study to demonstrate non-inferiority of GSK Biologicals’ Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process) when administered as a single dose to subjects aged 2-30 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00227422 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y Vaccine Trade Name: Mencevax Study Indication: Infections, Meningococcal
Link
http://www.pfizer.com/research/clinical_trials/trial_data_and_results
Palavras-chave
Versões (1)
- 26/05/2019 26/05/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
26 de maio de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Mencevax™ ACWY (new process) versus Mencevax™ ACWY (current process); NCT00227422
Visit 1 - Month 0 - Vaccination
- StudyEvent: ODM
Similar models
Visit 1 - Month 0 - Vaccination
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Elimination Criteria During the Study
C0680251 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Pharmaceutical Preparations, Vaccination
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the study period.
boolean
C0013227 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
C0042196 (UMLS CUI [2])
Immunosuppressive Agents, Chronic
Item
[B] Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,2])
Vaccination, Concomitant Agent
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from vaccine administration and ending 30 days after.
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Immunoglobulins, Blood Product
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C0456388 (UMLS CUI [1,2])
Informed Consent, Date in time
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Institution name, Identifier
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
African Heritage / African American (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other, specify (10)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Protocol Compliance
Item
Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visit) should be enrolled in the study.
boolean
C0525058 (UMLS CUI [1])
Gender, Age
Item
A male or female between, and including 2 and 30 years of age at the time of vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Healthy
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C3898900 (UMLS CUI [1])
Childbearing Potential; Contraceptive methods
Item
If the subject is female, she must be of non-childbearing potential. If a subject is a female of childbearing potential, she 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® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0700589 (UMLS CUI [2])
Pharmaceutical Preparations
Item
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of study vaccine, or planned use during the study period.
boolean
C0013227 (UMLS CUI [1])
Immunosuppressive Agents
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1])
Meningococcal vaccine, Previous
Item
Vaccination with a meningococcal vaccine within the last five years.
boolean
C0700144 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
Concomitant Agent, Vaccination, Planned
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 15 days before vaccine administration and ending 30 days after.
boolean
C2347852 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Meningitis, Meningococcal, Serogroup A, Medical History; Meningitis, Meningococcal, Serogroup B, Medical History; Meningitis, Meningococcal, Serogroup C, Medical History; Meningitis, Meningococcal, Serogroup Y, Medical History; Meningitis, Meningococcal, Serogroup W-135, Medical History
Item
History of meningococcal serogroup A, C, W135 or Y disease.
boolean
C1135745 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1135746 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1135747 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C1136209 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
C1136210 (UMLS CUI [5,1])
C0262926 (UMLS CUI [5,2])
C0262926 (UMLS CUI [1,2])
C1135746 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1135747 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C1136209 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
C1136210 (UMLS CUI [5,1])
C0262926 (UMLS CUI [5,2])
Meningitis, Meningococcal, Serogroup A, Exposure to; Meningitis, Meningococcal, Serogroup B, Exposure to; Meningitis, Meningococcal, Serogroup C, Exposure to; Meningitis, Meningococcal, Serogroup Y, Exposure to; Meningitis, Meningococcal, Serogroup W-135, Exposure to
Item
Known exposure to meningococcal serogroup A, C, W135 or Y disease or contacts with subjects who had meningococcal disease.
boolean
C1135745 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C1135746 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C1135747 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C1136209 (UMLS CUI [4,1])
C0332157 (UMLS CUI [4,2])
C1136210 (UMLS CUI [5,1])
C0332157 (UMLS CUI [5,2])
C0332157 (UMLS CUI [1,2])
C1135746 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C1135747 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C1136209 (UMLS CUI [4,1])
C0332157 (UMLS CUI [4,2])
C1136210 (UMLS CUI [5,1])
C0332157 (UMLS CUI [5,2])
Immunologic Deficiency Syndromes
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
boolean
C0021051 (UMLS CUI [1])
Immunodeficiency congenital, Family history; Immunologic Deficiency Syndromes, 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])
C0241889 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0241889 (UMLS CUI [2,3])
Vaccination, Hypersensitivity
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
C0042196 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
Acute Disease
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, Axillary temperature < 37.5°C (99.5 °F).
boolean
C0001314 (UMLS CUI [1])
Immunoglobulins, Blood product
Item
Administration of immunoglobulins and/or any blood products within the three months preceding administration of study vaccine or planned use during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C0456388 (UMLS CUI [1,2])
Pregnancy; Breast Feeding
Item
Pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Alcohol consumption, chronic, Medical History; Drug abuse, Medical History
Item
History of chronic alcohol consumption and/or drug abuse.
boolean
C0001948 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0013146 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0205191 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0013146 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Pregnancy, Planned
Item
Female planning to become pregnant in the next two months.
boolean
C0032992 (UMLS CUI [1])
Disease, Interferes with, Result
Item
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Randomization, Numbers
Item
Record treatment number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0031809 (UMLS CUI-2)
Disease; Symptoms
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
C0012634 (UMLS CUI [1])
C1457887 (UMLS CUI [2])
C1457887 (UMLS CUI [2])
CL Item
Cutaneous (1)
CL Item
Eyes (2)
CL Item
Ears-Nose-Throat (3)
CL Item
Cardiovascular (4)
CL Item
Respiratory (5)
CL Item
Gastrointestinal (6)
CL Item
Muskuloskeletal (7)
CL Item
Neurological (8)
CL Item
Genitourinary (9)
CL Item
Haematology (10)
CL Item
Allergies (12)
CL Item
Endocrine (13)
CL Item
Other (specify) (14)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Past or Current?
text
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
CL Item
Past (1)
CL Item
Current (2)
Item Group
Laboratory Tests - Blood Sample
C0005834 (UMLS CUI-1)
Collection of blood specimen for laboratory procedure
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure, Date in time
Item
Date if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (not of childbearing potential or male) (3)
Urine Specimen Collection, Date in time
Item
Date (Please complete only if different from visit date)
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Vaccine Administration
C0042196 (UMLS CUI-1)
C2368628 (UMLS CUI-2)
C2368628 (UMLS CUI-2)
Vaccination, Administration of Vaccine, Date in time
Item
Date if different from visit date
date
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Vaccination, Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0042196 (UMLS CUI [1,1])
C0005903 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0005903 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Item
Route
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,4])
CL Item
Axillary (1)
Item
Vaccine Administration (only one box must be ticked by vaccine)
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
Code List
Vaccine Administration (only one box must be ticked by vaccine)
CL Item
MencevaxTM ACWY Vaccine (1)
CL Item
Not administered (2)
Vaccination, Administration of Vaccine, Vial Device, Replacement, Numbers
Item
If Replacement vial, give number
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C0559956 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C0559956 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
Vaccination, Administration of Vaccine, Vial Device, Wrong, Numbers
Item
If Wrong vial, give number
integer
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C3827420 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C3827420 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
Item
Side / Site, Route
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
Code List
Side / Site, Route
CL Item
Upper left, Deltoid, S.C. (Upper left, Deltoid, S.C.)
Vaccination, Administration of Vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol?
boolean
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Item
If No, Side
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
If No, Site
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If No, Route
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C (2)
Item
Why not administered? Please tick the major reason for non administration.
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Why not administered? Please tick the major reason for non administration.
CL Item
Serious adverse event (Please specify SAE No.) (1)
CL Item
Non-Serious adverse event. (Please specify AE No.) (2)
CL Item
Other, please specify (3)
Item
Please tick who made the decision
text
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
Please tick who made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Unsolicited Adverse Event
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?
text
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
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 available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
Item Group
Solicited Adverse Events - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0545082 (UMLS CUI-4)
C0332307 (UMLS CUI-5)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0545082 (UMLS CUI-4)
C0332307 (UMLS CUI-5)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Adverse Event, Symptoms, Local
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Adverse Event, Symptoms, Local, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
Item
Medically attended visit - Type
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,5])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,5])
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Solicited Adverse Events - General Symptoms - "2-5 Years"
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
C0159028 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
Item
General Symptoms
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
CL Item
Temperature, give °C (Axillary) (1)
CL Item
Irritability/Fussiness, give intensity (2)
CL Item
Drowsiness, give intensity (3)
CL Item
Loss of appetite, give intensity (4)
Adverse Event, General symptom
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Adverse Event, General symptom, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Adverse Event, General symptom, Etiology aspects
Item
Causality
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
Adverse Event, General symptom, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item
Medically attended visit - Type
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Solicited Adverse Events - General Symptoms - "6-30 Years"
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
C0159028 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
Item
General Symptoms
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
CL Item
Fever, give °C (Axillary) (1)
CL Item
Fatigue, give intensity (2)
CL Item
Headache, give intensity (3)
CL Item
Gastrointestinal symptoms, give intensity (4)
Adverse Event, General symptom
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom, Continuous
Item
Ongoing after Day 3
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Adverse Event, General symptom, End Date
Item
Date of last Day of Symptoms
date
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Adverse Event, General symptom, Etiology aspects
Item
Causality
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
Adverse Event, General symptom, Visit/Advice
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item
Medically attended visit - Type
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
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