ID

34660

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 (2)
  1. 1/18/19 1/18/19 -
  2. 1/22/19 1/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 22, 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

English

Visit 1 104727 ( DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months) ) - Informed Consent, Check Inclusion and Exclusion criteria, Demography, Randomisation/ Treatment Allocation

1 forms  
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
I certify that Informed Consent has been obtained prior to any study procedure.
Description

Informed Consent obtained

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Informed Consent Date
Description

Informed Consent Date

Data type

date

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

Demographics

Alias
UMLS CUI-1
C1704791
Previous studies
Description

Previous studies

Data type

integer

Alias
UMLS CUI [1]
C2242969
Enter subject number of previous study.
Description

Subject number of previous study

Data type

integer

Alias
UMLS CUI [1,1]
C2242969
UMLS CUI [1,2]
C2348585
Center Number
Description

Center Number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Eligibility Check
Description

Eligibility Check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Description

Did the subject meet all the entry criteria?

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria Violation
Description

Inclusion Criteria Violation

Alias
UMLS CUI-1
C1709750
UMLS CUI-2
C1512693
UMLS CUI-3
C1516637
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.
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
A male or female between, and including: 15 and 24 months of age (i.e. as of 14 months +1 day until 25 months -1 day of age or 427 to 730 days old) at the time of vaccination.
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
Written informed consent obtained from the parent or guardian of the subject.
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0030551
UMLS CUI [3]
C0023226
Healthy subjects as established by medical history and clinical examination before entering into the study.
Description

Healthy subjects as established by medical history and clinical examination before entering into the study.

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0262926
UMLS CUI [3]
C1456356
Having participated in the primary vaccination safety study DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or safety study DTPW-HBV=HIB-MENAC-TT-003 (e Track No. 100480).
Description

Primary vaccination safety study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion Criteria Violation
Description

Exclusion Criteria Violation

Alias
UMLS CUI-1
C1709750
UMLS CUI-2
C0680251
UMLS CUI-3
C1516637
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.
Description

Investigational or non- registered product use other than the study vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0242510
UMLS CUI [2]
C0042210
Chronic administration (defined as more than 14 days) of immunosuppresants or other immune- modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone, or equivalent , >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
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
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
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
Booster vaccination against diphteria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/ or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study DTPW=HB-MENAC-TT-003 (eTrack No. 100480).
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
History of diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease.
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
Known exposure to diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease.
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
Any confirmed or suspected immunosuppresive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Description

Any confirmed or suspected immunosuppresive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

Data type

boolean

Alias
UMLS CUI [1,1]
C3829792
UMLS CUI [1,2]
C0021051
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
A family history of congenital or hereditary immunodeficiency.
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
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
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
Major congenital defects or serious chronic illness.
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
History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.
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
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 low- grade febrile illness, i. e. axillary temperature <37.5.°C).
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
Administration of immunoglobulins and/ or any blood products within the three months preceding the vaccination or planned administration during the study period.
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
Randomization/ Treatment Allocation
Description

Randomization/ Treatment Allocation

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0087111
UMLS CUI-3
C1706778
Record treatment number
Description

Treatment number

Data type

text

Alias
UMLS CUI [1]
C1522541
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Similar models

Visit 1 104727 ( DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months) ) - Informed Consent, Check Inclusion and Exclusion criteria, Demography, Randomisation/ Treatment Allocation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent obtained
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
C0021430 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Item
Previous studies
integer
C2242969 (UMLS CUI [1])
Previous studies
Code List
Previous studies
CL Item
100480(DTPW-HBV=HIB-MENAC-TT-003) (1)
Subject number of previous study
Item
Enter subject number of previous study.
integer
C2242969 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria Violation
C1709750 (UMLS CUI-1)
C1512693 (UMLS CUI-2)
C1516637 (UMLS CUI-3)
Parents/ guardians can and will comply with the requirements of the protocol
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
C1321605 (UMLS CUI [1,1])
C1709747 (UMLS CUI [1,2])
C3176968 (UMLS CUI [2])
C1522577 (UMLS CUI [3])
C4041024 (UMLS CUI [4])
Age at the time of vaccination
Item
A male or female between, and including: 15 and 24 months of age (i.e. as of 14 months +1 day until 25 months -1 day of age or 427 to 730 days old) at the time of vaccination.
boolean
C0001779 (UMLS CUI [1])
Written informed consent
Item
Written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1])
C0030551 (UMLS CUI [2])
C0023226 (UMLS CUI [3])
Healthy subjects as established by medical history and clinical examination before entering into the study.
Item
Healthy subjects as established by medical history and clinical examination before entering into the study.
boolean
C1708335 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C1456356 (UMLS CUI [3])
Primary vaccination safety study
Item
Having participated in the primary vaccination safety study DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or safety study DTPW-HBV=HIB-MENAC-TT-003 (e Track No. 100480).
boolean
C2348568 (UMLS CUI [1])
Item Group
Exclusion Criteria Violation
C1709750 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
C1516637 (UMLS CUI-3)
Investigational or non- registered product use other than the study 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
C0242510 (UMLS CUI [1])
C0042210 (UMLS CUI [2])
Chronic administration of immunosuppresants or other immune- modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppresants or other immune- modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone, or equivalent , >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
C0021083 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0449238 (UMLS CUI [2])
C0042196 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C0032952 (UMLS CUI [5])
Planned administration/ administration of a vaccine
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
boolean
C1533734 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2])
Booster vaccination against diphteria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/ or meningococcal serogroups A and C disease
Item
Booster vaccination against diphteria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/ or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study DTPW=HB-MENAC-TT-003 (eTrack No. 100480).
boolean
C0419731 (UMLS CUI [1])
C0042196 (UMLS CUI [2,1])
C0012546 (UMLS CUI [2,2])
C0042196 (UMLS CUI [3,1])
C0039614 (UMLS CUI [3,2])
C0042196 (UMLS CUI [4,1])
C0043167 (UMLS CUI [4,2])
C0042196 (UMLS CUI [5,1])
C0121772 (UMLS CUI [5,2])
C0042196 (UMLS CUI [6,1])
C0025303 (UMLS CUI [6,2])
History of diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease.
Item
History of diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease.
boolean
C0012546 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0039614 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0043167 (UMLS CUI [3,1])
C0262926 (UMLS CUI [3,2])
C0019163 (UMLS CUI [4,1])
C0262926 (UMLS CUI [4,2])
C0025303 (UMLS CUI [5,1])
C0262926 (UMLS CUI [5,2])
Known exposure to diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease
Item
Known exposure to diphteria, tetanus, pertussis, hepatitis B, Hib and/ or meningococcal serogroup A or C disease.
boolean
C0012546 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
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])
Any confirmed or suspected immunosuppresive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Item
Any confirmed or suspected immunosuppresive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
boolean
C3829792 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
A family history of congenital or hereditary immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0241889 (UMLS CUI [1,1])
C0853602 (UMLS CUI [1,2])
C0439660 (UMLS CUI [1,3])
C0021051 (UMLS CUI [1,4])
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C2106654 (UMLS CUI [1])
C0235874 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
Major congenital defects or serious chronic illness
Item
Major congenital defects or serious chronic illness.
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [1,3])
C0205404 (UMLS CUI [1,4])
History of any neurologic disorders or seizures including febrile seizures in infancy
Item
History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.
boolean
C0027765 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0009952 (UMLS CUI [2])
C0231330 (UMLS CUI [3])
Acute disease at the time of enrolment
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 low- grade febrile illness, i. e. axillary temperature <37.5.°C).
boolean
C0001314 (UMLS CUI [1,1])
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])
C2945599 (UMLS CUI [6,2])
Administration of immunoglobulins and/ or any 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
C1533734 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C1533734 (UMLS CUI [2,1])
C0456388 (UMLS CUI [2,2])
C0042196 (UMLS CUI [3])
C1533734 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Item Group
Randomization/ Treatment Allocation
C0034656 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C1706778 (UMLS CUI-3)
Treatment number
Item
Record treatment number
text
C1522541 (UMLS CUI [1])
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