ID

22975

Description

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

Keywords

Versions (1)
  1. 6/19/17 6/19/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 19, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Visit 1: GSK DTPa vaccine (Infanrix) 100484

English

Study ID: 100484 Visit 1

1 forms  
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Informed Consent Date
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Data type

time

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Did the child participate in the Swedish Institute for Infectious Disease Control (Smittskyddsinstitutet) pertussis vaccine trial II 1993-1996?
Description

pertussis vaccine trial

Data type

integer

Alias
UMLS CUI [1,1]
C0031237
UMLS CUI [1,2]
C0008976
pertussis vaccine trial, type of vaccine
Description

Did the child participate in the Swedish Institute for Infectious Disease Control (Smittskyddsinstitutet) pertussis vaccine trial II 1993-1996? If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0031237
UMLS CUI [1,2]
C0332307
Has the child received vaccine against pertussis?
Description

Did the child participate in the Swedish Institute for Infectious Disease Control (Smittskyddsinstitutet) pertussis vaccine trial II 1993-1996? If No, please specify

Data type

text

Alias
UMLS CUI [1]
C0031237
Has the child, according to the parent or medical history, had pertussis disease?
Description

pertussis disease

Data type

text

Alias
UMLS CUI [1]
C0043167
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

Did the subject meet all the entry criteria?

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Tick the box next to any of the inclusion criteria the subject failed

Data type

integer

Alias
UMLS CUI [1]
C1512693
Exclusion Criteria
Description

Tick the box next to any of the exclusion criteria the subject met.

Data type

integer

Alias
UMLS CUI [1]
C0680251
General Medical History / Physical Examination
Description

General Medical History / Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Description

If Yes, please tick appropriate box(es) and give diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1457887
Cutaneous: Diagnosis
Description

Cutaneous disease

Data type

text

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0011900
Cutaneous disease
Description

Cutaneous disease

Data type

integer

Alias
UMLS CUI [1]
C0037274
Eyes: Diagnosis
Description

Disorder of eye

Data type

text

Alias
UMLS CUI [1,1]
C0015397
UMLS CUI [1,2]
C0011900
Disorder of eye
Description

Disorder of eye

Data type

integer

Alias
UMLS CUI [1]
C0015397
Ears-nose-throat: Diagnosis
Description

Ears-nose-throat disorder

Data type

text

Alias
UMLS CUI [1,1]
C0395797
UMLS CUI [1,2]
C0011900
Ears-nose-throat disorder
Description

Ears-nose-throat disorder

Data type

integer

Alias
UMLS CUI [1]
C0395797
Cardiovascular: Diagnosis
Description

Cardiovascular disorder

Data type

text

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0011900
Cardiovascular disorder
Description

Cardiovascular disorder

Data type

integer

Alias
UMLS CUI [1]
C0007222
Respiratory: Diagnosis
Description

Respiratory disorder

Data type

text

Alias
UMLS CUI [1,1]
C0035204
UMLS CUI [1,2]
C0011900
Respiratory disorder
Description

Respiratory disorder

Data type

integer

Alias
UMLS CUI [1]
C0035204
Gastrointestinal: Diagnosis
Description

Gastrointestinal disorder

Data type

text

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0011900
Gastrointestinal disorder
Description

Gastrointestinal disorder

Data type

integer

Alias
UMLS CUI [1]
C0017178
Muskuloskeletal: Diagnosis
Description

Musculoskeletal disorder

Data type

text

Alias
UMLS CUI [1,1]
C0026857
UMLS CUI [1,2]
C0011900
Musculoskeletal disorder
Description

Musculoskeletal disorder

Data type

integer

Alias
UMLS CUI [1]
C0026857
Neurological: Diagnosis
Description

Neurological disorder

Data type

text

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0011900
Neurological disorder
Description

Neurological disorder

Data type

integer

Alias
UMLS CUI [1]
C0027765
Genitourinary: Diagnosis
Description

Genitourinary disorder

Data type

text

Alias
UMLS CUI [1,1]
C0080276
UMLS CUI [1,2]
C0011900
Genitourinary disorder
Description

Genitourinary disorder

Data type

integer

Alias
UMLS CUI [1]
C0080276
Haematology: Diagnosis
Description

Hematology disorder

Data type

text

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0011900
Hematology disorder
Description

Hematology disorder

Data type

integer

Alias
UMLS CUI [1]
C0018939
Allergies: Diagnosis
Description

Allergies

Data type

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0011900
Allergies
Description

Allergies

Data type

integer

Alias
UMLS CUI [1]
C0020517
Endocrine: Diagnosis
Description

Endocrine disorder

Data type

text

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0011900
Endocrine disorder
Description

Endocrine disorder

Data type

integer

Alias
UMLS CUI [1]
C0014130
Other disorder, please specify
Description

Other disorder

Data type

text

Other disorder
Description

Other disorder

Data type

integer

Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
Has a blood sample been taken?
Description

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
blood sample date
Description

Has a blood sample been taken? If Yes, Please complete only if different from visit date:

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0042196
Date of Vaccine Administration
Description

Please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Vaccine Administration
Description

Vaccine Administration

Data type

integer

Alias
UMLS CUI [1]
C2368628
Administration Side
Description

Administration Side

Data type

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Administration Site
Description

Administration Site

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Administration Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the Protocol ?
Description

Study vaccine Administration

Data type

boolean

Alias
UMLS CUI [1]
C2368628
Study vaccine Administration: Side
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Site
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Study vaccine Administration: Route
Description

Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Vial code
Description

Vial code

Data type

text

Alias
UMLS CUI [1]
C1545852
Vaccine Administration Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Adverse Events, Post-Vaccination Observation
Description

Adverse Events, Post-Vaccination Observation

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0700325
UMLS CUI-3
C0877248
Has the subject experienced any serious or non-serious unsolicited adverse events within one month postvaccination?
Description

serious or non-serious unsolicited adverse events

Data type

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
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Similar models

Study ID: 100484 Visit 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
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])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
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])
pertussis vaccine trial
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])
type of vaccine
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)
CL Item
Unknown (5)
Item
Has the child received vaccine against pertussis?
text
C0031237 (UMLS CUI [1])
pertussis vaccine trial
Code List
Has the child received vaccine against pertussis?
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])
pertussis disease
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)
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
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])
Inclusion Criteria
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])
Exclusion Criteria
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)
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
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])
Cutaneous disease
Item
Cutaneous: Diagnosis
text
C0037274 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Cutaneous disease
integer
C0037274 (UMLS CUI [1])
Cutaneous disease
Code List
Cutaneous disease
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])
Item
Disorder of eye
integer
C0015397 (UMLS CUI [1])
Cutaneous disease
Code List
Disorder of eye
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])
Item
Ears-nose-throat disorder
integer
C0395797 (UMLS CUI [1])
Cutaneous disease
Code List
Ears-nose-throat disorder
CL Item
Past (1)
CL Item
Current (2)
Cardiovascular disorder
Item
Cardiovascular: Diagnosis
text
C0007222 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Cardiovascular disorder
integer
C0007222 (UMLS CUI [1])
Cutaneous disease
Code List
Cardiovascular disorder
CL Item
Past (1)
CL Item
Current (2)
Respiratory disorder
Item
Respiratory: Diagnosis
text
C0035204 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Respiratory disorder
integer
C0035204 (UMLS CUI [1])
Cutaneous disease
Code List
Respiratory disorder
CL Item
Past (1)
CL Item
Current (2)
Gastrointestinal disorder
Item
Gastrointestinal: Diagnosis
text
C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Gastrointestinal disorder
integer
C0017178 (UMLS CUI [1])
Cutaneous disease
Code List
Gastrointestinal disorder
CL Item
Past (1)
CL Item
Current (2)
Musculoskeletal disorder
Item
Muskuloskeletal: Diagnosis
text
C0026857 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Musculoskeletal disorder
integer
C0026857 (UMLS CUI [1])
Cutaneous disease
Code List
Musculoskeletal disorder
CL Item
Past (1)
CL Item
Current (2)
Neurological disorder
Item
Neurological: Diagnosis
text
C0027765 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Neurological disorder
integer
C0027765 (UMLS CUI [1])
Cutaneous disease
Code List
Neurological disorder
CL Item
Past (1)
CL Item
Current (2)
Genitourinary disorder
Item
Genitourinary: Diagnosis
text
C0080276 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Genitourinary disorder
integer
C0080276 (UMLS CUI [1])
Cutaneous disease
Code List
Genitourinary disorder
CL Item
Past (1)
CL Item
Current (2)
Hematology disorder
Item
Haematology: Diagnosis
text
C0018939 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Hematology disorder
integer
C0018939 (UMLS CUI [1])
Cutaneous disease
Code List
Hematology disorder
CL Item
Past (1)
CL Item
Current (2)
Allergies
Item
Allergies: Diagnosis
text
C0020517 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Allergies
integer
C0020517 (UMLS CUI [1])
Cutaneous disease
Code List
Allergies
CL Item
Past (1)
CL Item
Current (2)
Endocrine disorder
Item
Endocrine: Diagnosis
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Endocrine disorder
integer
C0014130 (UMLS CUI [1])
Cutaneous disease
Code List
Endocrine disorder
CL Item
Past (1)
CL Item
Current (2)
Other disorder
Item
Other disorder, please specify
text
Item
Other disorder
integer
Cutaneous disease
Code List
Other disorder
CL Item
Past (1)
CL Item
Current (2)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-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])
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
C0042196 (UMLS CUI-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])
Vaccine Administration
Code List
Vaccine Administration
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])
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])
Study vaccine Administration
Code List
Study vaccine Administration: Side
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])
Study vaccine Administration Site
Code List
Study vaccine Administration: Site
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])
Study vaccine Administration Route
Code List
Study vaccine Administration: Route
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)
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])
serious or non-serious unsolicited adverse events
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)
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