ID
34056
Description
Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. 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
Keywords
Versions (3)
- 1/13/19 1/13/19 -
- 1/18/19 1/18/19 -
- 1/22/19 1/22/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 13, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727
Visit 1 - Informed Consent, Check Inclusion and Exclusion criteria, Demography, Randomisation/ Treatment Allocation
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Previous studies
Data type
integer
Alias
- UMLS CUI [1]
- C2242969
Description
Subject number of previous study
Data type
integer
Alias
- UMLS CUI [1,1]
- C2242969
- UMLS CUI [1,2]
- C2348585
Description
Center Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Description
Inclusion Criteria Violation
Alias
- UMLS CUI-1
- C1709750
- UMLS CUI-2
- C1512693
- UMLS CUI-3
- C1516637
Description
Parents/ guardians can and will comply with the requirements of the protocol
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C1709747
- UMLS CUI [2]
- C3176968
- UMLS CUI [3]
- C1522577
- UMLS CUI [4]
- C4041024
Description
Note: The largest interval will be used in case the different definitions lead to time intervals that do not coincide.
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Written informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C0030551
- UMLS CUI [3]
- C0023226
Description
Health problems established by medical history and clinical examination
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1446390
- UMLS CUI [1,2]
- C0332296
- UMLS CUI [2]
- C0262926
- UMLS CUI [3]
- C1456356
Description
Primary vaccination safety study
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Exclusion Criteria Violation
Alias
- UMLS CUI-1
- C1709750
- UMLS CUI-2
- C0680251
- UMLS CUI-3
- C1516637
Description
Investigational or non- registered product use other than the study vaccine
Data type
boolean
Alias
- UMLS CUI [1]
- C0242510
- UMLS CUI [2]
- C0042210
Description
Chronic administration of immunosuppresants or other immune- modifying drugs
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021083
- UMLS CUI [1,2]
- C0205191
- UMLS CUI [2]
- C0449238
- UMLS CUI [3]
- C0042196
- UMLS CUI [4]
- C0001617
- UMLS CUI [5]
- C0032952
Description
Note: Oral Poliovirus vaccine can be given concomitantly.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C1301732
- UMLS CUI [2]
- C0042210
Description
Booster vaccination against diphteria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/ or meningococcal serogroups A and C disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0419731
- UMLS CUI [2,1]
- C0042196
- UMLS CUI [2,2]
- C0012546
- UMLS CUI [3,1]
- C0042196
- UMLS CUI [3,2]
- C0039614
- UMLS CUI [4,1]
- C0042196
- UMLS CUI [4,2]
- C0043167
- UMLS CUI [5,1]
- C0042196
- UMLS CUI [5,2]
- C0121772
- UMLS CUI [6,1]
- C0042196
- UMLS CUI [6,2]
- C0025303
Description
History of diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012546
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C0039614
- UMLS CUI [2,2]
- C0262926
- UMLS CUI [3,1]
- C0043167
- UMLS CUI [3,2]
- C0262926
- UMLS CUI [4,1]
- C0019163
- UMLS CUI [4,2]
- C0262926
- UMLS CUI [5,1]
- C0025303
- UMLS CUI [5,2]
- C0262926
Description
Known exposure to diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012546
- UMLS CUI [1,2]
- C0332157
- UMLS CUI [2,1]
- C0039614
- UMLS CUI [2,2]
- C0332157
- UMLS CUI [3,1]
- C0043167
- UMLS CUI [3,2]
- C0332157
- UMLS CUI [4,1]
- C0019163
- UMLS CUI [4,2]
- C0332157
- UMLS CUI [5,1]
- C0025303
- UMLS CUI [5,2]
- C0332157
Description
Any confirmed or suspected immunosuppresive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3829792
- UMLS CUI [1,2]
- C0021051
- UMLS CUI [2]
- C0019682
Description
A family history of congenital or hereditary immunodeficiency
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C0853602
- UMLS CUI [1,3]
- C0439660
- UMLS CUI [1,4]
- C0021051
Description
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Data type
boolean
Alias
- UMLS CUI [1]
- C2106654
- UMLS CUI [2]
- C0235874
- UMLS CUI [3]
- C0042210
Description
Major congenital defects or serious chronic illness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C0205164
- UMLS CUI [1,3]
- C0008679
- UMLS CUI [1,4]
- C0205404
Description
Note: In case of one event, the investigator will take into account the special warnings and special precautions for use.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027765
- UMLS CUI [1,2]
- C0036572
- UMLS CUI [2]
- C0009952
- UMLS CUI [3]
- C0231330
Description
Acute disease at the time of enrolment
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0001314
- UMLS CUI [1,2]
- C4041024
- UMLS CUI [2,1]
- C0012634
- UMLS CUI [2,2]
- C0221423
- UMLS CUI [2,3]
- C0205081
- UMLS CUI [2,4]
- C0205082
- UMLS CUI [2,5]
- C0332281
- UMLS CUI [2,6]
- C0015967
- UMLS CUI [3]
- C2368628
- UMLS CUI [4]
- C0205165
- UMLS CUI [5]
- C0011991
- UMLS CUI [6,1]
- C0041912
- UMLS CUI [6,2]
- C2945599
Description
Administration of immunoglobulins and/ or any blood products
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0021027
- UMLS CUI [2,1]
- C1533734
- UMLS CUI [2,2]
- C0456388
- UMLS CUI [3]
- C0042196
- UMLS CUI [4,1]
- C1533734
- UMLS CUI [4,2]
- C1301732
Description
Randomization/ Treatment Allocation
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C1706778
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Visit 1 - Informed Consent, Check Inclusion and Exclusion criteria, Demography, Randomisation/ Treatment Allocation
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C0262926 (UMLS CUI [5,2])
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C0039614 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0043167 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4,1])
C0332157 (UMLS CUI [4,2])
C0025303 (UMLS CUI [5,1])
C0332157 (UMLS CUI [5,2])
C0021051 (UMLS CUI [1,2])
C0019682 (UMLS CUI [2])
C0853602 (UMLS CUI [1,2])
C0439660 (UMLS CUI [1,3])
C0021051 (UMLS CUI [1,4])
C0235874 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [1,3])
C0205404 (UMLS CUI [1,4])
C0036572 (UMLS CUI [1,2])
C0009952 (UMLS CUI [2])
C0231330 (UMLS CUI [3])
C4041024 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0221423 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
C0205082 (UMLS CUI [2,4])
C0332281 (UMLS CUI [2,5])
C0015967 (UMLS CUI [2,6])
C2368628 (UMLS CUI [3])
C0205165 (UMLS CUI [4])
C0011991 (UMLS CUI [5])
C0041912 (UMLS CUI [6,1])
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C0021027 (UMLS CUI [1,2])
C1533734 (UMLS CUI [2,1])
C0456388 (UMLS CUI [2,2])
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C1301732 (UMLS CUI [4,2])
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