ID

34664

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 (2)
  1. 22-01-19 22-01-19 -
  2. 22-01-19 22-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 januari 2019

DOI

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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

Engels

103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18M)) - Medication; Non- Serious Adverse Events; Study Conclusion

1 Formulieren  
Medication
Beschrijving

Medication

Alias
UMLS CUI-1
C0013227
Has any medications/ treatments been administered during study period?
Beschrijving

If yes, please complete the following table.

Datatype

boolean

Alias
UMLS CUI [1]
C3469597
Medication
Beschrijving

Medication

Alias
UMLS CUI-1
C0013227
Trade/ Generic Name
Beschrijving

Trade/ Generic Name

Datatype

text

Alias
UMLS CUI [1]
C2360065
UMLS CUI [2]
C0592502
Medical Indication
Beschrijving

Medical Indication

Datatype

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Total daily dose
Beschrijving

Total daily dose

Datatype

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Medication Administration route
Beschrijving

Medication Administration route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Medication Start Date
Beschrijving

Medication Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication End Date
Beschrijving

Medication End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication continuing at end of study
Beschrijving

Medication continuing at end of study

Datatype

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0444930
Non- serious Adverse Event
Beschrijving

Non- serious Adverse Event

Alias
UMLS CUI-1
C1518404
Has any non- serious adverse event occured within one month (minimum 30 days) post- vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschrijving

Has any non- serious adverse event occured within one month post- vaccination?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
Non- serious Adverse Event
Beschrijving

Non- serious Adverse Event

Alias
UMLS CUI-1
C1518404
Non- serious adverse event Description
Beschrijving

Non- serious adverse event Description

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Administration site or Non- administration site?
Beschrijving

Administration site or Non- administration site?

Datatype

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Start Date Non- serious Adverse Event
Beschrijving

Start Date Non- serious Adverse Event

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Start Date Non- serious Adverse Event during immediate post- vaccination period (30 minutes)?
Beschrijving

Start Date Non- serious Adverse Event during immediate post- vaccination period (30 minutes)?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C2368628
UMLS CUI [1,4]
C0687676
Stop Date Non- serious Adverse Event
Beschrijving

Stop Date Non- serious Adverse Event

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non- serious Adverse Event Intensity
Beschrijving

Non- serious Adverse Event Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
Relationship to investigatoinal products
Beschrijving

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Non- serious Adverse Event Outcome
Beschrijving

Non- serious Adverse Event Outcome

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Medically attended visit
Beschrijving

If yes, please specify type.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Medically attended visit specification
Beschrijving

Medically attended visit specification

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C2348235
Study Conclusion
Beschrijving

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the subject experience any Serious Adverse Event during the study period?
Beschrijving

Did the subject experience any Serious Adverse Event during the study period?

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
If subject experiences Serious Adverse Event, specify total number of Serious Adverse Events
Beschrijving

Total number of Serious Adverse Events

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Did any elimination criteria become applicable during the study?
Beschrijving

Did any elimination criteria become applicable during the study?

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
Specify elimination criteria
Beschrijving

Specify elimination criteria

Datatype

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348235
Was the subject withdrawn from study?
Beschrijving

Was the subject withdrawn from study?

Datatype

boolean

Alias
UMLS CUI [1]
C0422727
Please tick the ONE most appropriate category for withdrawal
Beschrijving

Please tick the ONE most appropriate category for withdrawal

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
If reason for withdrawal is Non- serious Adverse Event, specify.
Beschrijving

If reason for withdrawal is Non- serious Adverse Event, specify.

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
UMLS CUI [2]
C1518404
If reason for withdrawal is protocol violation, specify
Beschrijving

If reason for withdrawal is protocol violation, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
UMLS CUI [2]
C1709750
If other reason for withdrawal, specify
Beschrijving

If other reason for withdrawal, specify

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Please tick, who took decision
Beschrijving

Please tick, who took decision

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Date of last contact
Beschrijving

Date of last contact

Datatype

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Beschrijving

If no, please give details within the Adverse Events section.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0805839
Investigator's signature
Beschrijving

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschrijving

I confirm that I have reviewed the date in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Beschrijving

Printed Investigator's name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Investigator's signature date
Beschrijving

Investigator's signature date

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18M)) - Medication; Non- Serious Adverse Events; Study Conclusion

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Medication
C0013227 (UMLS CUI-1)
Has any medications/ treatments been administered during study period?
Item
Has any medications/ treatments been administered during study period?
boolean
C3469597 (UMLS CUI [1])
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade/ Generic Name
Item
Trade/ Generic Name
text
C2360065 (UMLS CUI [1])
C0592502 (UMLS CUI [2])
Item
Medical Indication
integer
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical Indication
Code List
Medical Indication
CL Item
Prophylactic (1)
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Medication Administration route
Item
Medication Administration route
text
C0013153 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication End Date
Item
Medication End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Medication continuing at end of study
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0444930 (UMLS CUI [2,2])
Medication continuing at end of study
Code List
Medication continuing at end of study
CL Item
Medication continuing (1)
Item Group
Non- serious Adverse Event
C1518404 (UMLS CUI-1)
Has any non- serious adverse event occured within one month post- vaccination?
Item
Has any non- serious adverse event occured within one month (minimum 30 days) post- vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
Item Group
Non- serious Adverse Event
C1518404 (UMLS CUI-1)
Non- serious adverse event Description
Item
Non- serious adverse event Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Administration site or Non- administration site?
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Administration site or Non- administration site?
Code List
Administration site or Non- administration site?
CL Item
Administration site (L)
CL Item
Non- administration site (G)
Start Date Non- serious Adverse Event
Item
Start Date Non- serious Adverse Event
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Date Non- serious Adverse Event during immediate post- vaccination period (30 minutes)?
Item
Start Date Non- serious Adverse Event during immediate post- vaccination period (30 minutes)?
boolean
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
Stop Date Non- serious Adverse Event
Item
Stop Date Non- serious Adverse Event
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non- serious Adverse Event Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Non- serious Adverse Event Intensity
Code List
Non- serious Adverse Event Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigatoinal products
Item
Relationship to investigatoinal products
boolean
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Non- serious Adverse Event Outcome
integer
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non- serious Adverse Event Outcome
Code List
Non- serious Adverse Event Outcome
CL Item
Recovered/ Resolved (1)
CL Item
Recovering/ Resolving (2)
CL Item
Not recovered/ not resolved (3)
CL Item
Recovered with sequelae/ Resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item
Medically attended visit specification
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Medically attended visit specification
Code List
Medically attended visit specification
CL Item
Hospitalisation  (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Did the subject experience any Serious Adverse Event during the study period?
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
Total number of Serious Adverse Events
Item
If subject experiences Serious Adverse Event, specify total number of Serious Adverse Events
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Did any elimination criteria become applicable during the study?
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
Specify elimination criteria
Item
Specify elimination criteria
text
C0680251 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Was the subject withdrawn from study?
Item
Was the subject withdrawn from study?
boolean
C0422727 (UMLS CUI [1])
Item
Please tick the ONE most appropriate category for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Please tick the ONE most appropriate category for withdrawal
Code List
Please tick the ONE most appropriate category for withdrawal
CL Item
Serious adverse event (SAE)
CL Item
Non- serious adverse event (complete Non- serious Adverse Event section), please specify (AEX)
CL Item
Protocol violation, please specify (PTV)
CL Item
Consent withdrawal, not due to an adverse event (CWS)
CL Item
Migrated/ moved from the study area (MIG)
CL Item
Lost to follow- up (LFU)
CL Item
Other, please specify (OTH)
If reason for withdrawal is Non- serious Adverse Event, specify.
Item
If reason for withdrawal is Non- serious Adverse Event, specify.
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
If reason for withdrawal is protocol violation, specify
Item
If reason for withdrawal is protocol violation, specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1709750 (UMLS CUI [2])
If other reason for withdrawal, specify
Item
If other reason for withdrawal, specify
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Please tick, who took decision
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Please tick, who took decision
Code List
Please tick, who took decision
CL Item
Investigator (I)
CL Item
Parents/ Guardians (P)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Was the subject in good condition at date of last contact?
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,3])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Investigator's signature date
Item
Investigator's signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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