Informationen:
Fehler:
ID
23227
Beschreibung
Study ID: 100480 Clinical Study ID: 100480 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 3: 24 – 30 months of age and at least 6 months (183 days) after Visit 1
Link
https://clinicaltrials.gov/ct2/show/NCT00317161
Stichworte
Versionen (1)
- 29.06.17 29.06.17 -
Hochgeladen am
29. Juni 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 3 NCT00317161
Visit 3 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161
Ähnliche Modelle
Visit 3 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
vaccination
Item
Has the subject had any serious adverse event since the last visit (i.e. Visit 2) of the DTP booster stage (15 to 24 monhts of age) and before the start of this booster vaccination ?
boolean
C1519255 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
C0042196 (UMLS CUI [2])
number of SAEs
Item
Specify number of SAEs
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
CL 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. (1)
CL Item
Chronic administration (defined as more than 14 days) of immunosuppressants 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). (2)
CL Item
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral Poliovirus vaccine will be given concomitantly. (3)
CL Item
Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480). (4)
CL Item
History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease. (5)
CL Item
Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease. (6)
CL Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). (7)
CL Item
A family history of congenital or hereditary immunodeficiency. (8)
CL Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. (9)
CL Item
Major congenital defects or serious chronic illness. (10)
CL Item
History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy. Note: In case of one event, the investigator will take into account the special warnings and special precautions for use. (11)
CL 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 lowgrade febrile illness, i.e. axillary temperature <37.5°C). (12)
CL Item
Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period. (13)
Record treatment number
Item
Record treatment number:
integer
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0031809 (UMLS CUI-2)
pre-existing conditions or signs and/or symptoms
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present prior to the start of the study?
boolean
C0262926 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
Skin and subcutaneous tissue
Item
Skin and subcutaneous tissue: Diagnosis
text
C0178301 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Musculoskeletal and connective tissue
Item
Musculoskeletal and connective tissue: Diagnosis
text
C0026857 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Item
Musculoskeletal and connective tissue
integer
C0026857 (UMLS CUI [1])
CL Item
Left (1)
CL Item
Right (2)
Cardiac
Item
Cardiac: Diagnosis
text
C0018799 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
undefined item
Item
Vascular: Diagnosis
text
C0042373 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Respiratory, thoracic and mediastinal
Item
Respiratory, thoracic and mediastinal: Diagnosis
text
C0851355 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Item
Respiratory, thoracic and mediastinal
integer
C0851355 (UMLS CUI [1])
CL Item
Left (1)
CL Item
Right (2)
Gastrointestinal
Item
Gastrointestinal: Diagnosis
text
C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Hepatobiliary
Item
Hepatobiliary: Diagnosis
text
C0267792 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Renal and urinary
Item
Renal and urinary: Diagnosis
text
C0042075 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Nervous system
Item
Nervous system: Diagnosis
text
C0027765 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Eye
Item
Eye: Diagnosis
text
C0015397 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Ear and labyrinth
Item
Ear and labyrinth: Diagnosis
text
C0851354 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Endocrine
Item
Endocrine: Diagnosis
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Metabolism and nutrition
Item
Metabolism and nutrition: Diagnosis
text
C0851358 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Blood and lymphatic system
Item
Blood and lymphatic system: Diagnosis
text
C0851353 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Immune system
Item
Immune system (incl allergies, autoimmune disorders): Diagnosis
text
C0021053 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Infections and infestations
Item
Infections and infestations: Diagnosis
text
C0009450 (UMLS CUI [1,1])
C0851341 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0851341 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Infections and infestations
integer
C0009450 (UMLS CUI [1,1])
C0851341 (UMLS CUI [1,2])
C0851341 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
Neoplasms benign, malignant and unspecified
Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps): Diagnosis
text
C1882062 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Item
Neoplasms benign, malignant and unspecified
integer
C1882062 (UMLS CUI [1])
CL Item
Left (1)
CL Item
Right (2)
Surgical and medical procedures
Item
Surgical and medical procedures: Diagnosis
text
C1948041 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Item
Surgical and medical procedures
integer
C1948041 (UMLS CUI [1])
CL Item
Left (1)
CL Item
Right (2)
Other disorder
Item
Other disorder, please specify
text
C0012634 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Left (1)
CL Item
Right (2)
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item Group
Vaccine Administration, Single Injection, Booster Dose
C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0700144 (UMLS CUI-3)
C0042196 (UMLS CUI-2)
C0700144 (UMLS CUI-3)
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature:
float
C0005903 (UMLS CUI [1])
Item
Pre-Vaccination temperature Route:
text
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,2])
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
CL Item
Mencevax ACWY Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (Please complete below) (4)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1])
Administration Side
Item
Administration Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Site
Item
Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Item
Please tick the major reason for non administration
integer
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
Serious adverse event Number
Item
Serious adverse event Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Non-serious adverse event Number
Item
Non-serious adverse event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
reason for non administration
Item
reason for non administration, if other please specify
text
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Item
Please tick who made the decision
integer
C1533734 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1])
Study vaccine Administration Side
Item
Study vaccine Administration: Side
integer
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item
Study vaccine Administration: Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Study vaccine Administration Route
Item
Study vaccine Administration: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Item Group
Solicited Adverse Events - Local Symptoms - Booster Dose
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0700144 (UMLS CUI-4)
C0877248 (UMLS CUI-5)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0700144 (UMLS CUI-4)
C0877248 (UMLS CUI-5)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Booster Dose
text
C1457887 (UMLS CUI [1])
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period? Booster Dose
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Redness
Item
Redness
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Redness
Item
Redness, size (mm)
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 0
Item
Redness on Day 0
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 1
Item
Redness on Day 1
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 2
Item
Redness on Day 2
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness on Day 3
Item
Redness on Day 3
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness ongoing after day 3
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332575 (UMLS CUI [2])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Swelling
Item
Swelling
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Swelling
Item
Swelling, size (mm)
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 0
Item
Swelling on Day 0
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 1
Item
Swelling on Day 1
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 2
Item
Swelling on Day 2
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling on Day 3
Item
Swelling on Day 3
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Swelling ongoing after day 3
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Item
Pain, intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 0
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 1
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 2
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Pain on Day 3
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Pain ongoing after day 3
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0030193 (UMLS CUI [2])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Item Group
Solicited Adverse Events - General Symptoms
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0700144 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C0042196 (UMLS CUI-2)
C0700144 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Fever
Item
Fever
float
C0015967 (UMLS CUI [1])
Item
Fever, Site of measurement
text
C0449687 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
CL Item
taken (1)
CL Item
not taken (2)
Fever on Day 0
Item
Fever on Day 0
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Fever on Day 1
Item
Fever on Day 1
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Fever on Day 2
Item
Fever on Day 2
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Fever on Day 3
Item
Fever on Day 3
float
C0005903 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Fever ongoing after day 3
Item
Fever ongoing after day 3?
boolean
C0015967 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0015967 (UMLS CUI [2])
C0015967 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0015967 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0015967 (UMLS CUI [2])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Drowsiness
Item
Drowsiness
boolean
C0013144 (UMLS CUI [1])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Drowsiness ongoing after day 3
Item
Drowsiness ongoing after day 3?
boolean
C0013144 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0013144 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C0013144 (UMLS CUI [2])
C0013144 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [2])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0013144 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0013144 (UMLS CUI [2])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Irritability/Fussiness
Item
Irritability/Fussiness
boolean
C0022107 (UMLS CUI [1])
Item
Irritability/Fussiness, Intensity
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability/Fussiness on Day 0
integer
C0022107 (UMLS CUI [1])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability/Fussiness on Day 1
integer
C0022107 (UMLS CUI [1])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability/Fussiness on Day 2
integer
C0022107 (UMLS CUI [1])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Irritability/Fussiness on Day 3
integer
C0022107 (UMLS CUI [1])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Irritability/Fussiness ongoing after day 3
Item
Irritability/Fussiness ongoing after day 3?
boolean
C0022107 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0022107 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality
boolean
C0015127 (UMLS CUI [1])
C0022107 (UMLS CUI [2])
C0022107 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [2])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0022107 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0022107 (UMLS CUI [2])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Loss of appetite
Item
Loss of appetite
boolean
C1971624 (UMLS CUI [1])
Item
Loss of appetite, Intensity
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
None (0)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Loss of appetite ongoing after day 3
Item
Loss of appetite ongoing after day 3?
boolean
C1971624 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C1971624 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1])
C1971624 (UMLS CUI [2])
C1971624 (UMLS CUI [2])
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [2])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [2])
Item
Medically attended visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1971624 (UMLS CUI [2])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1971624 (UMLS CUI [2])
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
Item Group
Unsolicited Adverse Events
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])
C0042196 (UMLS CUI [2])
C0042196 (UMLS CUI [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 (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. (Y)