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ID
22975
Beschreibung
Study ID: 100484 Clinical Study ID: 100484 (DTPa) Study Title: An open prospective study of immunogenicity and reactogenicity of DTPa vaccine (Infanrix) given as a booster to healthy school children 10 to 12 years of age Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed Trade Name: BIO DTPA (INFANRIX); Infanrix Study Indication: Acellular Pertussis; Diphtheria; Tetanus; acellular pertussis Documentation: Visit 1
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- 19.06.17 19.06.17 -
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GlaxoSmithKline
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19. Juni 2017
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Visit 1: GSK DTPa vaccine (Infanrix) 100484
Study ID: 100484 Visit 1
- StudyEvent: ODM
Ähnliche Modelle
Study ID: 100484 Visit 1
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
C0021430 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
male (1)
CL Item
female (2)
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
Other (6)
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])
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?
CL Item
Yes (1)
CL Item
No (2)
Item
pertussis vaccine trial, type of vaccine
integer
C0031237 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
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)
CL Item
Unknown (5)
Item
Has the child received vaccine against pertussis?
text
C0031237 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
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?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
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)
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)
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 in the subject prior to the start of the study?
boolean
C0262926 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
Cutaneous disease
Item
Cutaneous: Diagnosis
text
C0037274 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Disorder of eye
Item
Eyes: Diagnosis
text
C0015397 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Ears-nose-throat disorder
Item
Ears-nose-throat: Diagnosis
text
C0395797 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Cardiovascular disorder
Item
Cardiovascular: Diagnosis
text
C0007222 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Respiratory disorder
Item
Respiratory: Diagnosis
text
C0035204 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Gastrointestinal disorder
Item
Gastrointestinal: Diagnosis
text
C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Musculoskeletal disorder
Item
Muskuloskeletal: Diagnosis
text
C0026857 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Neurological disorder
Item
Neurological: Diagnosis
text
C0027765 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Genitourinary disorder
Item
Genitourinary: Diagnosis
text
C0080276 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Hematology disorder
Item
Haematology: Diagnosis
text
C0018939 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Allergies
Item
Allergies: Diagnosis
text
C0020517 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Endocrine disorder
Item
Endocrine: Diagnosis
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Past (1)
CL Item
Current (2)
Other disorder
Item
Other disorder, please specify
text
CL Item
Past (1)
CL Item
Current (2)
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])
C0005834 (UMLS CUI [1,2])
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI-2)
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])
CL Item
DTPa Vaccine (1)
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])
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])
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])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
CL Item
Left (1)
CL Item
Right (2)
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])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Study vaccine Administration: Route
integer
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
CL Item
I.M. (1)
CL Item
S.C. (2)
Vial code
Item
Vial code
text
C1545852 (UMLS CUI [1])
Comments
Item
Vaccine Administration Comments
text
C0947611 (UMLS CUI [1])
Item Group
Adverse Events, Post-Vaccination Observation
C0042196 (UMLS CUI-1)
C0700325 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0700325 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
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])
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
No (2)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (3)