ID
34690
Beschrijving
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
Trefwoorden
Versies (1)
- 23-01-19 23-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 januari 2019
DOI
Voor een aanvraag inloggen.
Licentie
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
104727 (DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months)) - Local symptoms; General Symptoms
Beschrijving
DTPw/HBV/Hib Vaccine
Alias
- UMLS CUI-1
- C0042210
Beschrijving
Vaccination side
Datatype
text
Alias
- UMLS CUI [1]
- C0441987
Beschrijving
Vaccination site
Datatype
text
Alias
- UMLS CUI [1]
- C1116171
Beschrijving
Date of vaccination
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042196
Beschrijving
DTPw/HBV/Hib Vaccine - Local Symptoms
Alias
- UMLS CUI-1
- C0042210
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beschrijving
Local symptoms
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beschrijving
Redness / Swelling - Size Day 0
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
- UMLS CUI [3]
- C0011008
Beschrijving
Pain - Intensity Day 0
Datatype
integer
Alias
- UMLS CUI [1]
- C1320357
- UMLS CUI [2]
- C0011008
Beschrijving
Redness / Swelling - Size Day 1
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
- UMLS CUI [3]
- C0011008
Beschrijving
Pain - Intensity Day 1
Datatype
integer
Alias
- UMLS CUI [1]
- C1320357
- UMLS CUI [2]
- C0011008
Beschrijving
Redness/ Swelling - Size Day 2
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
- UMLS CUI [3]
- C0011008
Beschrijving
Pain - Intensity Day 2
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1320357
- UMLS CUI [1,2]
- C0011008
Beschrijving
Redness/ Swelling - Size Day 3
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
- UMLS CUI [3]
- C0011008
Beschrijving
Pain - Intensity Day 3
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1320357
- UMLS CUI [1,2]
- C0011008
Beschrijving
Ongoing after day 3?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0549178
Beschrijving
Date of last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1457887
Beschrijving
Medically attended Visit?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
Beschrijving
Meningitec Vaccine
Alias
- UMLS CUI-1
- C0700144
Beschrijving
Vaccination side
Datatype
text
Alias
- UMLS CUI [1]
- C0441987
Beschrijving
Vaccination site
Datatype
text
Alias
- UMLS CUI [1]
- C1116171
Beschrijving
Date of vaccination
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042196
Beschrijving
Meningitec Vaccine - Local symptoms
Alias
- UMLS CUI-1
- C0700144
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beschrijving
Local symptoms
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
Beschrijving
Redness/ Swelling - Size Day 0
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
- UMLS CUI [3]
- C0011008
Beschrijving
Pain - Intensity Day 0
Datatype
integer
Alias
- UMLS CUI [1]
- C1320357
- UMLS CUI [2]
- C0011008
Beschrijving
Redness / Swelling - Size Day 1
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
- UMLS CUI [3]
- C0011008
Beschrijving
Pain - Intensity Day 1
Datatype
integer
Alias
- UMLS CUI [1]
- C1320357
- UMLS CUI [2]
- C0011008
Beschrijving
Redness/ Swelling - Size Day 2
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
- UMLS CUI [3]
- C0011008
Beschrijving
Pain - Intensity Day 2
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1320357
- UMLS CUI [1,2]
- C0011008
Beschrijving
Redness/ Swelling - Size Day 3
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
- UMLS CUI [3]
- C0011008
Beschrijving
Pain - Intensity Day 3
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1320357
- UMLS CUI [1,2]
- C0011008
Beschrijving
Ongoing after day 3?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0549178
Beschrijving
Date of last Day of Symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1457887
Beschrijving
Medically attended Visit?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
Beschrijving
Other local Symptoms
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beschrijving
Description - please specify side(s) and site(s)
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
- UMLS CUI [2,1]
- C0441987
- UMLS CUI [2,2]
- C2348235
- UMLS CUI [3,1]
- C1515974
- UMLS CUI [3,2]
- C2348235
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C0518690
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
End date, if not continuing.
Datatype
date
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
If continuing check box
Datatype
integer
Alias
- UMLS CUI [1]
- C0549178
Beschrijving
Medically attended visit?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
Beschrijving
General Symptoms
Alias
- UMLS CUI-1
- C0159028
Beschrijving
Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C1531924
- UMLS CUI [1,2]
- C0011008
Beschrijving
Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C1531924
- UMLS CUI [1,2]
- C0011008
Beschrijving
Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C1531924
- UMLS CUI [1,2]
- C0011008
Beschrijving
Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C1531924
- UMLS CUI [1,2]
- C0011008
Beschrijving
Temperature - Ongoing after Day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0549178
Beschrijving
Date of last Day of Temperature
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0806020
Beschrijving
Temperature - Medically attended visit?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0332575
- UMLS CUI [1,4]
- C0005903
Beschrijving
Intensity of Irratibility/ Fusiness Day 0
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
Intensity of Irratibility/ Fusiness - Day 1 Evening
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
Intensity of Irratibility/ Fusiness - Day 2 Evening
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
Intensity of Irratibility/ Fusiness - Day 3 Evening
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
I.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C2721683
Beschrijving
Irritability/ Fusiness - In case of intensity 3, was the crying unaltered >= 3 hours?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2,1]
- C0438697
- UMLS CUI [2,2]
- C0449238
Beschrijving
Irritability/ Fussiness - Ongoing after Day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0549178
Beschrijving
Date of last Day of Irritability/ Fussiness
Datatype
date
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0806020
Beschrijving
Irritability/ Fusiness - Medically attended Visit?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0022107
Beschrijving
Intensity of Drowsiness - Day 0
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
Intensity of Drowsiness - Day 1 Evening
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
Intensity of Drowsiness - Day 2 Evening
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
Intensity of Drowsiness - Day 3 Evening
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
Drowsiness - Ongoing after Day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0549178
Beschrijving
Date of last Day of Drowsiness
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0806020
Beschrijving
Drowsiness - Medically attended Visit?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013144
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1386497
Beschrijving
Intensity of Loss of appetite - Day 0
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
Intensity of Loss of appetite - Day 1 Evening
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
Intensity of Loss of appetite - Day 2 Evening
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
Intensity of Loss of appetite - Day 3 Evening
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [2]
- C0011008
Beschrijving
Loss of appetite - Ongoing after Day 3?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0549178
Beschrijving
Date of last Day of Loss of appetite
Datatype
text
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0806020
Beschrijving
Loss of appetite - Medically attended Visit?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1971624
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1386497
Beschrijving
Date of vaccination
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042196
Beschrijving
Other general symptoms
Alias
- UMLS CUI-1
- C0029625
Beschrijving
Description - please give details below
Datatype
text
Alias
- UMLS CUI [1]
- C0678257
- UMLS CUI [2]
- C1522508
Beschrijving
Intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C0518690
Beschrijving
General Symptoms Start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0808070
Beschrijving
Check box if continuous
Datatype
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0806020
Beschrijving
Check box, if general symptoms are continuing.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0549178
Beschrijving
Medication
Alias
- UMLS CUI-1
- C0013227
Beschrijving
Medication Trade/ Generic name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0592502
Beschrijving
Reason for medication
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0392360
Beschrijving
Total daily dose
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0439810
Beschrijving
Medication Start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
Medication Stop date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Tick box, if continuing
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Similar models
104727 (DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months)) - Local symptoms; General Symptoms
C0042196 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
C0011008 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0441987 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
C1386497 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C0005903 (UMLS CUI [1,4])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C2721683 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0438697 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0549178 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0549178 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0549178 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,2])
C1522508 (UMLS CUI [2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0592502 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])