Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
time
C0011008 (UMLS CUI [1,1])
C0021430 (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
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
Item
Did the child participate in the Swedish Institute for Infectious Disease Control (Smittskyddsinstitutet) pertussis vaccine trial II 1993-1996?
integer
C0031237 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Code List
Did the child participate in the Swedish Institute for Infectious Disease Control (Smittskyddsinstitutet) pertussis vaccine trial II 1993-1996?
Item
pertussis vaccine trial, type of vaccine
integer
C0031237 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
pertussis vaccine trial, type of vaccine
CL Item
British whole cell vaccine DTPw (1)
CL Item
Italian 3-component DTPa (2)
CL Item
Canadian 5-component DTPa (3)
CL Item
Belgian 2-component DTPa (4)
Item
Has the child received vaccine against pertussis?
text
C0031237 (UMLS CUI [1])
Code List
Has the child received vaccine against pertussis?
Item
Has the child, according to the parent or medical history, had pertussis disease?
text
C0043167 (UMLS CUI [1])
Code List
Has the child, according to the parent or medical history, had pertussis disease?
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item
Inclusion Criteria
integer
C1512693 (UMLS CUI [1])
Code List
Inclusion Criteria
CL Item
A male or female between, 10 and 12 years of age at the time of the first vaccination. (1)
CL Item
Written informed consent from at least one of the pupil’s guardians and signature of the pupil. (2)
CL Item
Vaccinated after ordinary Swedish program with three doses DT vaccine before 2 years of age. (3)
CL Item
The family is able to understand the information, co-operate and communicate orally and in writing in Swedish. (4)
Item
Exclusion Criteria
integer
C0680251 (UMLS CUI [1])
Code List
Exclusion Criteria
CL Item
Severe chronic disease (including finished treatment of tuberculosis). (1)
CL Item
More than 3 doses diphtheria-, tetanus- and/or whooping cough vaccine previous in life or some dose during the last two years. (2)
CL Item
Epilepsy or other severe central nervous system disease. (3)
CL Item
Suspected or confirmed immune defect (including HIV infection). (4)
CL Item
Immunological treatment (cyclosporin, alkylating agents, anti-metabolites, anti-lymphocyte globulin, monoclonal antibodies, oral corticosteroids) or infusion of blood products during last month. (5)
CL Item
Other experimental or unregistered medication intake during the last month. (6)
CL Item
Acute fever disease with temperature >380C at the time point of the planned booster dose (7)
CL Item
Planned moving from the district during the study period. (8)
pre-existing conditions or signs and/or 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
C0262926 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Cutaneous disease
Item
Cutaneous: Diagnosis
text
C0037274 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Cutaneous disease
integer
C0037274 (UMLS CUI [1])
Code List
Cutaneous disease
Disorder of eye
Item
Eyes: Diagnosis
text
C0015397 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Disorder of eye
integer
C0015397 (UMLS CUI [1])
Code List
Disorder of eye
Ears-nose-throat disorder
Item
Ears-nose-throat: Diagnosis
text
C0395797 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Ears-nose-throat disorder
integer
C0395797 (UMLS CUI [1])
Code List
Ears-nose-throat disorder
Cardiovascular disorder
Item
Cardiovascular: Diagnosis
text
C0007222 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Cardiovascular disorder
integer
C0007222 (UMLS CUI [1])
Code List
Cardiovascular disorder
Respiratory disorder
Item
Respiratory: Diagnosis
text
C0035204 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Respiratory disorder
integer
C0035204 (UMLS CUI [1])
Code List
Respiratory disorder
Gastrointestinal disorder
Item
Gastrointestinal: Diagnosis
text
C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Gastrointestinal disorder
integer
C0017178 (UMLS CUI [1])
Code List
Gastrointestinal disorder
Musculoskeletal disorder
Item
Muskuloskeletal: Diagnosis
text
C0026857 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Musculoskeletal disorder
integer
C0026857 (UMLS CUI [1])
Code List
Musculoskeletal disorder
Neurological disorder
Item
Neurological: Diagnosis
text
C0027765 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Neurological disorder
integer
C0027765 (UMLS CUI [1])
Code List
Neurological disorder
Genitourinary disorder
Item
Genitourinary: Diagnosis
text
C0080276 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Genitourinary disorder
integer
C0080276 (UMLS CUI [1])
Code List
Genitourinary disorder
Hematology disorder
Item
Haematology: Diagnosis
text
C0018939 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Hematology disorder
integer
C0018939 (UMLS CUI [1])
Code List
Hematology disorder
Allergies
Item
Allergies: Diagnosis
text
C0020517 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Allergies
integer
C0020517 (UMLS CUI [1])
Endocrine disorder
Item
Endocrine: Diagnosis
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Endocrine disorder
integer
C0014130 (UMLS CUI [1])
Code List
Endocrine disorder
Other disorder
Item
Other disorder, please specify
text
Item
Other disorder
integer
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
blood sample date
Item
blood sample date
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Date of Vaccine Administration
Item
Date of Vaccine Administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Code List
Vaccine Administration
CL Item
Not administered (please complete below) (2)
Administration Side
Item
Administration Side
text
C0441987 (UMLS CUI [1,1])
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])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Study vaccine Administration
Item
Has the study vaccine been administered according to the Protocol ?
boolean
C2368628 (UMLS CUI [1])
Item
Study vaccine Administration: Side
integer
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
Study vaccine Administration: Side
Item
Study vaccine Administration: Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
Study vaccine Administration: Site
Item
Study vaccine Administration: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Code List
Study vaccine Administration: Route
Vial code
Item
Vial code
text
C1545852 (UMLS CUI [1])
Comments
Item
Vaccine Administration Comments
text
C0947611 (UMLS CUI [1])
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?
integer
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?
CL Item
Information not retrievable (1)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (3)