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24771
Beschreibung
Study ID: 100478 Clinical Study ID: 100478 Study Title: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290303 Sponsor: GlaxoSmithKline 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 This form contains the VISIT 1 form
Stichworte
Versionen (1)
- 16.08.17 16.08.17 -
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GlaxoSmithKline
Hochgeladen am
16. August 2017
DOI
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GSK non-inferiority of Tritanrix Hepatitis B VISIT 1 NCT00290303
GSK non-inferiority of Tritanrix Hepatitis B VISIT 1 NCT00290303
- StudyEvent: ODM
Ähnliche Modelle
GSK non-inferiority of Tritanrix Hepatitis B VISIT 1 NCT00290303
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
CHECK FOR STUDY CONTINUATION
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Did the subject return for visit 1 ?
Item
Did the subject return for visit 1 ?
boolean
C0545082 (UMLS CUI [1])
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other, please specify: (3)
no return other
Item
If no return because:
text
C0545082 (UMLS CUI [1,1])
C1548100 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1548100 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
ELIMINATION CRITERIA DURING THE STUDY
C0013893 (UMLS CUI-1)
investigational or non-registered product
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
C0013227 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
immunemodifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone, or equivalent, ³ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1])
vaccine
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination; with the exception of OPV.
boolean
C0042210 (UMLS CUI [1])
meningococcal vaccine
Item
Vaccination with meningococcal vaccine after Visit 1 administered outside of the study protocol.
boolean
C0700144 (UMLS CUI [1])
meningococcal disease
Item
History of meningococcal serogroup A or C disease.
boolean
C0025303 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
meningococcal disease
Item
Known exposure to meningococcal serogroup A or C disease.
boolean
C0025303 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,2])
immunodeficient condition
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])
hereditary immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0021051 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0439660 (UMLS CUI [1,2])
Hypersensitivity
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1])
congenital defects
Item
Major congenital defects or serious chronic illness.
boolean
C0220810 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C0008679 (UMLS CUI [1,2])
Acute disease
Item
Acute disease. (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])
immunoglobulins 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
C0021027 (UMLS CUI [1,1])
C0371802 (UMLS CUI [1,2])
C0371802 (UMLS CUI [1,2])
hypersensitivity vaccine
Item
Known hypersensitivity to any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Item Group
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
C0683526 (UMLS CUI-1)
Anaphylactic reaction
Item
For DTP containing vaccine administered at 15 to 24 months of age: Anaphylactic reaction following the administration of vaccine in the primary vaccination study.
boolean
C0002792 (UMLS CUI [1])
hypersensitivity
Item
For DTP containing vaccine administered at 15 to 24 months of age: Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Encephalopathy
Item
For DTP containing vaccine administered at 15 to 24 months of age: Encephalopathy (not due to another identifiable cause) in the primary vaccination study. This is defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination, and generally consisting of 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. In these circumstances the vaccination course should be continued with DT and hepatitis B vaccines.
text
C0085584 (UMLS CUI [1])
Anaphylactic
Item
For Mencevax™ ACWY vaccine administered at 24 to 30 months of age : Anaphylactic reaction following the administration of vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
hypersensitivity
Item
For Mencevax™ ACWY vaccine administered at 24 to 30 months of age : Known hypersensitivity to any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
Acute disease
Item
For both the DTP containing vaccine administered at 15 to 24 months of age and the Mencevax™ ACWY vaccine administered at 24 to 30 months of age : The following AEs constitute contraindications to administration of any vaccine at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE. Acute disease at the time of vaccination. (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])
Axillary temperature
Item
For both the DTP containing vaccine administered at 15 to 24 months of age and the Mencevax™ ACWY vaccine administered at 24 to 30 months of age : The following AEs constitute contraindications to administration of any vaccine at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE. Axillary temperature > 37.5°C at the time of vaccination.
boolean
C1531924 (UMLS CUI [1])
Item Group
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
C0683526 (UMLS CUI-1)
Axillary temperature
Item
Special warnings and special precautions for use For DTP containing vaccine administered at 15 to 24 months of age: If any of the following events occurred in temporal relation to receipt of DTPw-HBV in the primary vaccination study, the decision to boost with vaccines containing the pertussis component should be carefully considered: Axillary temperature of ³ 40°C within 48 hours of vaccination, not due to an other identifiable cause.
boolean
C1531924 (UMLS CUI [1])
Collapse
Item
Special warnings and special precautions for use For DTP containing vaccine administered at 15 to 24 months of age: If any of the following events occurred in temporal relation to receipt of DTPw-HBV in the primary vaccination study, the decision to boost with vaccines containing the pertussis component should be carefully considered: Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of primary vaccination.
boolean
C0344329 (UMLS CUI [1])
crying
Item
Special warnings and special precautions for use For DTP containing vaccine administered at 15 to 24 months of age: If any of the following events occurred in temporal relation to receipt of DTPw-HBV in the primary vaccination study, the decision to boost with vaccines containing the pertussis component should be carefully considered: Persistent crying lasting > 3 hours, occurring within 48 hours of primary vaccination.
boolean
C0010399 (UMLS CUI [1])
Convulsions
Item
Special warnings and special precautions for use For DTP containing vaccine administered at 15 to 24 months of age: If any of the following events occurred in temporal relation to receipt of DTPw-HBV in the primary vaccination study, the decision to boost with vaccines containing the pertussis component should be carefully considered: Convulsions with or without fever, occurring within 3 days of primary vaccination.
boolean
C0495698 (UMLS CUI [1])
criteria
Item
Did the subject meet all the entry criteria?
boolean
C0242801 (UMLS CUI [1])
comply
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
age
Item
A male or female between, and including, 15 and 24 months of age (i.e. as of 14 months +1 day until 23 months +30 days of age or 427 to 730 days old) at the time of vaccination. Note: The largest interval will be used in case the different definitions lead to time intervals that do not coincide.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
Written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1])
Healthy
Item
Healthy subjects as established by medical history and clinical examination before entering into the study.
boolean
C3898900 (UMLS CUI [1])
primary vaccination study
Item
Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011
boolean
C0008972 (UMLS CUI [1])
drug or 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
C0013227 (UMLS CUI [1])
immunosuppressants
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, ³ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021081 (UMLS CUI [1])
vaccine
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination; with the exception of oral poliovirus vaccine (OPV). Note: OPV will be given concomitantly with DTPw-HBV/Hib at 15 to 24 months age.
boolean
C0042210 (UMLS CUI [1])
Booster vaccination
Item
Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT- 011
boolean
C0020975 (UMLS CUI [1])
History
Item
History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
boolean
C0019664 (UMLS CUI [1,1])
C0039614 (UMLS CUI [1,2])
C0012546 (UMLS CUI [1,3])
C0043167 (UMLS CUI [1,4])
C0019163 (UMLS CUI [1,5])
C1135745 (UMLS CUI [1,6])
C1135747 (UMLS CUI [1,7])
C0121772 (UMLS CUI [1,8])
C0039614 (UMLS CUI [1,2])
C0012546 (UMLS CUI [1,3])
C0043167 (UMLS CUI [1,4])
C0019163 (UMLS CUI [1,5])
C1135745 (UMLS CUI [1,6])
C1135747 (UMLS CUI [1,7])
C0121772 (UMLS CUI [1,8])
Known exposure
Item
Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
boolean
C0332157 (UMLS CUI [1,1])
C0039614 (UMLS CUI [1,2])
C0012546 (UMLS CUI [1,3])
C0043167 (UMLS CUI [1,4])
C0019163 (UMLS CUI [1,5])
C1135745 (UMLS CUI [1,6])
C1135747 (UMLS CUI [1,7])
C0121772 (UMLS CUI [1,8])
C0039614 (UMLS CUI [1,2])
C0012546 (UMLS CUI [1,3])
C0043167 (UMLS CUI [1,4])
C0019163 (UMLS CUI [1,5])
C1135745 (UMLS CUI [1,6])
C1135747 (UMLS CUI [1,7])
C0121772 (UMLS CUI [1,8])
immunosuppressive or immunodeficient condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
boolean
C0021079 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0021051 (UMLS CUI [1,2])
congenital or hereditary immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1])
allergic disease
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
C1521826 (UMLS CUI [1,2])
chronic illness
Item
Major congenital defects or serious chronic illness.
boolean
C0008679 (UMLS CUI [1])
neurologic disorders
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.
boolean
C0027765 (UMLS CUI [1])
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 lowgrade febrile illness, i.e. axillary temperature <37.5°C).
boolean
C0001314 (UMLS CUI [1])
administration of immunoglobulins
Item
Planned or actual administration of immunoglobulins and/or any blood products within the three months preceding Mencevax™ ACWY vaccination.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C0456388 (UMLS CUI [1,2])
Item Group
RANDOMISATION / TREATMENT ALLOCATION
C0034656 (UMLS CUI-1)
RANDOMISATION / TREATMENT ALLOCATION
Item
RANDOMISATION / TREATMENT ALLOCATION
integer
C0034656 (UMLS CUI [1])
Item Group
GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0031809 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
pre-existing conditions
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
boolean
C0521987 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Skin and subcutaneous tissue
Item
Skin and subcutaneous tissue
text
C0178301 (UMLS CUI [1])
Item
Musculoskeletal and connective tissue
integer
C0026857 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Musculoskeletal and connective tissue
Item
Musculoskeletal and connective tissue
text
C0026857 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Cardiac
Item
Cardiac
text
C0018799 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Item
Respiratory, thoracic and mediastinal
integer
C0851355 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Respiratory, thoracic and mediastinal
Item
Respiratory, thoracic and mediastinal
text
C0851355 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
CL Item
past (1)
CL Item
present (2)
Hepatobiliary
Item
Hepatobiliary
text
C0267792 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Renal and urinary
Item
Renal and urinary
text
C0042075 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Nervous system
Item
Nervous system
text
C0027765 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Eye
Item
Eye
text
C0015397 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Ear and labyrinth
Item
Ear and labyrinth
text
C0851354 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Endocrine
Item
Endocrine
text
C0014130 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
CL Item
past (1)
CL Item
present (2)
Item
Immune system (incl allergies, autoimmune disorders)
integer
C0021053 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Immune system
Item
Immune system (incl allergies, autoimmune disorders)
text
C0021053 (UMLS CUI [1])
Item
Infections and infestations
integer
C0009450 (UMLS CUI [1,1])
C0851341 (UMLS CUI [1,2])
C0851341 (UMLS CUI [1,2])
CL Item
past (1)
CL Item
present (2)
Infections and infestations
Item
Infections and infestations
text
C0009450 (UMLS CUI [1,1])
C0851341 (UMLS CUI [1,2])
C0851341 (UMLS CUI [1,2])
Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps)
integer
C1882062 (UMLS CUI [1])
Code List
Neoplasms benign, malignant and unspecified (incl cysts, polyps)
CL Item
past (1)
CL Item
present (2)
Neoplasms benign, malignant and unspecified
Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps)
text
C1882062 (UMLS CUI [1])
Item
Surgical and medical procedures
integer
C1948041 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Surgical and medical procedures
Item
Surgical and medical procedures
text
C1948041 (UMLS CUI [1])
CL Item
past (1)
CL Item
present (2)
Other
Item
Other
text
C0205394 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
integer
C0005903 (UMLS CUI [1])
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
CL Item
DTPw-HBV/Hib Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
Item
Side / Site Route
integer
C0441987 (UMLS CUI [1,1])
C0678813 (UMLS CUI [1,2])
C0678813 (UMLS CUI [1,2])
CL Item
Anterolateral (1)
CL Item
Left (2)
CL Item
Thigh (3)
CL Item
I.M. (4)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C0042196 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
Item
Has the study vaccine been administered according to the Protocol? Side?
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,2])
Code List
Has the study vaccine been administered according to the Protocol? Side?
CL Item
Left (1)
CL Item
Right (2)
Item
Has the study vaccine been administered according to the Protocol? Site?
integer
C2368628 (UMLS CUI [1,1])
C0205145 (UMLS CUI [1,2])
C0205145 (UMLS CUI [1,2])
Code List
Has the study vaccine been administered according to the Protocol? Site?
CL Item
Deltoid (1)
CL Item
Tigh (2)
CL Item
Buttock (3)
Item
Has the study vaccine been administered according to the Protocol? Route?
integer
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])
Code List
Has the study vaccine been administered according to the Protocol? Route?
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
Why not administered?
integer
C2368628 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other, please specify (3)
Why not administered?
Item
Why not administered? Other, please specify:
text
C2368628 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item
Please tick who made the decision:
integer
C2368628 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
PROTOCOL REQUIRED CONCOMITANT VACCINATION
C2347852 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI-2)
Have the following concomitant vaccine been administered?
Item
Have the following concomitant vaccine been administered? OPV VACCINE?
boolean
C2347852 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0032375 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C0032375 (UMLS CUI [1,3])
vaccine date
Item
Have the following concomitant vaccine been administered? OPV VACCINE? Date:
date
C2347852 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0032375 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,2])
C0032375 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Blood Sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Blood sample date
Item
Has a blood sample been taken?
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,2])
Item
INTENSITY FOR SOLICITED SYMPTOMS Pain at injection site
integer
C0877248 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries / protests on touch (2)
CL Item
Cries when limb is moved / spontaneously painful (3)
Item
INTENSITY FOR SOLICITED SYMPTOMS Drowsiness
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
INTENSITY FOR SOLICITED SYMPTOMS Irritability / fussiness
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual / no effect on normal activity (1)
CL Item
Crying more than usual / interferes with normal activity (2)
CL Item
Crying that cannot be comforted / prevents normal activity (3)
Item
INTENSITY FOR SOLICITED SYMPTOMS Loss of appetite
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual / no effect on normal activity (1)
CL Item
Eating less than usual / interferes with normal activity (2)
CL Item
Not eating at all (3)
CL Item
Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. interfering with everyday activities. (1)
CL Item
Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. (2)
CL Item
Severe: An adverse event which prevents normal, everyday activities (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice). (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice). (3)
CAUSALITY / RELATIONSHIP TO INVESTIGATIONAL PRODUCTS
Item
NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event.
boolean
C0013230 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
Recovered / Resolved (1)
CL Item
Recovering / Resolving: Subject is recovering at the time she/he completes the study or at the time she/he withdraws from study. (2)
CL Item
Not recovered / Not resolved: AE is ongoing at the time the subject completes the study or becomes lost to follow-up; in case of death AEs that are not the cause of death. (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
CL Item
Fatal: AE is the cause of death (only applicable for SAE reports) (5)