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ID
34517
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. Patient Level Data:N/A Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A 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)
- 1/18/19 1/18/19 -
- 1/22/19 1/22/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 18, 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 2 (104727 ( DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months) )) - Reason for non participation; Local symptoms; General Symptoms
Similar models
Visit 2 (104727 ( DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months) )) - Reason for non participation; Local symptoms; General Symptoms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Tracking Document Reason for non participation
C0558080 (UMLS CUI-1)
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
Previous Subject Number
Item
Previous Subject Number
text
C2348585 (UMLS CUI [1])
CL Item
759346/004 (DTPwHB/HibMenAC-TT-004) (1)
CL Item
100791(DTPW-HBV=HIB-MENAC-TT-013) (2)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Please document reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
CL Item
Subject not eligible? (Please specify criteria that are not fulfilled) (1)
CL Item
Subject lost to follow- up or not reached (2)
CL Item
Subject eligible but not willing to participate due to adverse events, or serious adverse event (Please specify) (3)
CL Item
Subject eligible but not willing to participate due to other (Please specify) (4)
CL Item
Subject died (please record date of death) (5)
Subject non eligible - Criteria that are not fulfilled
Item
Subject non eligible - Criteria that are not fulfilled
text
C3242266 (UMLS CUI [1])
specification of Adverse events, or serious adverse event
Item
specification of Adverse events, or serious adverse event
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Other reason for non participation
Item
Other reason for non participation
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Date of Contact
Item
Date of Contact
date
C0805839 (UMLS CUI [1])
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Size/ Intensity Day 0
Item
Redness, Swelling Size/ Day 0
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain Intensity Day 0
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
C0011008 (UMLS CUI [2])
CL Item
Absent (0)
CL Item
Minor reactoin to touch (1)
CL Item
Cries/ protests on touch (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Redness, Swelling Size/ Day 1 Evening
Item
Redness, Swelling Size/ Day 1 Evening
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain Intensity Day 1 Evening
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
C0011008 (UMLS CUI [2])
CL Item
Absent (0)
CL Item
Minor reactoin to touch (1)
CL Item
Cries/ protests on touch (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Redness, Swelling Size/ Day 2 Evening
Item
Swelling Size/ Day 2 Evening
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain Intensity Day 2 Evening
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Absent (0)
CL Item
Minor reactoin to touch (1)
CL Item
Cries/ protests on touch (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Swelling Size/ Day 3 Evening
Item
Swelling Size/ Day 3 Evening
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain Intensity Day 3 Evening
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Absent (0)
CL Item
Minor reactoin to touch (1)
CL Item
Cries/ protests on touch (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0806020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
Medically attended Visit?
Item
Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
Item Group
Other local Symptoms
C0205394 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Description - please specify side(s) and site(s)
Item
Description - please specify side(s) and site(s)
text
C0678257 (UMLS CUI [1])
C0441987 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
C0441987 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
CL Item
Mild (An adverse even which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities) (1)
CL Item
Moderate (An adverse event which is sufficiently discomforting to interfere with normal everyday activities) (2)
CL Item
An adverse event which prevents normal, everyday activities [In a young child, such an adverse event would, for example, prevent attendance at school/ kindergarten/ a day- care center and would cause the parents/ guardians to seek medical advice]) (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date, if not continuing.
Item
End date, if not continuing.
date
C0806020 (UMLS CUI [1])
CL Item
Continuing (1)
Medically attended visit?
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
Temperature (axillary) Day 0
Item
Temperature (axillary) Day 0
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Temperature (axillary) Day 1
Item
Temperature (axillary) Day 1
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Temperature (axillary) Day 2
Item
Temperature (axillary) Day 2
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Temperature (axillary) Day 3
Item
Temperature (axillary) Day 3
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Temperature - Ongoing after Day 3?
Item
Temperature - Ongoing after Day 3?
boolean
C0005903 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last Day of Temperature
Item
Date of last Day of Temperature
date
C0005903 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Temperature - Medically attended visit?
Item
Temperature - Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C0005903 (UMLS CUI [1,4])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C0005903 (UMLS CUI [1,4])
Item
Intensity of Irratibility/ Fusiness Day 0
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Item
Intensity of Irratibility/ Fusiness Day 1
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Item
Intensity of Irratibility/ Fusiness Day 2
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Item
Intensity of Irratibility/ Fusiness Day 3
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Irritability/ Fusiness - In case of intensity 3, was the crying continuous?
Item
Irritability/ Fusiness - In case of intensity 3, was the crying continuous?
boolean
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2721683 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C2721683 (UMLS CUI [2])
Irritability/ Fusiness - In case of intensity 3, was the crying unaltered >= 3 hours?
Item
Irritability/ Fusiness - In case of intensity 3, was the crying unaltered >= 3 hours?
boolean
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0438697 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0518690 (UMLS CUI [1,2])
C0438697 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Irritability/ Fussiness - Ongoing after Day 3?
Item
Irritability/ Fussiness - Ongoing after Day 3?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last Day of Irritability/ Fussiness
Item
Date of last Day of Irritability/ Fussiness
date
C0022107 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Irritability/ Fusiness - Medically attended Visit?
Item
Irritability/ Fusiness - Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
Item
Intensity of Drowsiness Day 0
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 1
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 2
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness Day 3
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Drowsiness - Ongoing after Day 3?
Item
Drowsiness - Ongoing after Day 3?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last Day of Drowsiness
Item
Date of last Day of Drowsiness
date
C0013144 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Drowsiness - Medically attended Visit?
Item
Drowsiness - Medically attended Visit?
boolean
C0013144 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Item
Intensity of Loss of appetite Day 0
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Item
Intensity of Loss of appetite Day 1
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Item
Intensity of Loss of appetite Day 2
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Item
Intensity of Loss of appetite Day 3
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Loss of appetite - Ongoing after Day 3?
Item
Loss of appetite - Ongoing after Day 3?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Date of last Day of Loss of appetite
Item
Date of last Day of Loss of appetite
text
C1971624 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Loss of appetite - Medically attended Visit?
Item
Loss of appetite - Medically attended Visit?
boolean
C1971624 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Description - please give details below
Item
Description - please give details below
text
C0678257 (UMLS CUI [1])
C1522508 (UMLS CUI [2])
C1522508 (UMLS CUI [2])
Intensity
Item
Intensity
integer
C0518690 (UMLS CUI [1])
General Symptoms Start date
Item
General Symptoms Start date
date
C0159028 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
General Symptoms End date
Item
General Symptoms End date
date
C0159028 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
Check box, if general symptoms are continuing.
integer
C0159028 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
Code List
Check box, if general symptoms are continuing.
CL Item
General Symptoms continuing (1)