ID

24687

Beschrijving

Study ID: 100478 Clinical Study ID: 100478 Study Title: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290303 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 This form contains the VISIT 3 form

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Versies (2)
  1. 13-08-17 13-08-17 -
  2. 27-08-17 27-08-17 -
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GlaxoSmithKline

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13 augustus 2017

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Creative Commons BY-NC 3.0
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GSK non-inferiority of Tritanrix Hepatitis B VISIT 3 NCT00290303

Engels

GSK non-inferiority of Tritanrix Hepatitis B VISIT 3 NCT00290303

1 Formulieren  
Reminders
Beschrijving

Reminders

Alias
UMLS CUI-1
C1709896
ELIMINATION CRITERIA
Beschrijving

ELIMINATION CRITERIA

Alias
UMLS CUI-1
C0680251
ADVERSE EVENTS
Beschrijving

ADVERSE EVENTS

Alias
UMLS CUI-1
C0877248
MEDICATION
Beschrijving

MEDICATION

Alias
UMLS CUI-1
C0013227
CHECK FOR STUDY CONTINUATION
Beschrijving

CHECK FOR STUDY CONTINUATION

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject return for visit 3 ?
Beschrijving

Did the subject return for visit 3 ?

Datatype

boolean

Alias
UMLS CUI [1]
C0545082
If no return because:
Beschrijving

no return

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1548100
If no return because:
Beschrijving

no return other

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1548100
UMLS CUI [1,3]
C0392360
Please tick who made the decision
Beschrijving

Decision

Datatype

integer

Alias
UMLS CUI [1]
C0679006
LABORATORY TESTS
Beschrijving

LABORATORY TESTS

Has a blood sample been taken?
Beschrijving

blood sample

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
blood sample date
Beschrijving

blood sample date

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
concomitant vaccination
Beschrijving

concomitant vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Beschrijving

vaccine

Datatype

integer

Alias
UMLS CUI [1]
C0042210
Trade / (Generic) Name
Beschrijving

Trade / (Generic) Name

Datatype

text

Alias
UMLS CUI [1]
C0027365
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Administration date
Beschrijving

Administration date

Datatype

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
Concomitant medication
Beschrijving

Concomitant medication

Alias
UMLS CUI-1
C2347852
Have any medications/treatments been administered during study period?
Beschrijving

Medication

Datatype

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0087111
Trade / Generic Name
Beschrijving

Trade / Generic Name

Datatype

text

Alias
UMLS CUI [1]
C0027365
Medical Indication
Beschrijving

Medical Indication

Datatype

text

Alias
UMLS CUI [1]
C2315323
Medical Indication: Prophylactic?
Beschrijving

Prophylactic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0199176
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0013227
Total Daily Dose
Beschrijving

Total Daily Dose

Datatype

text

Alias
UMLS CUI [1]
C2348070
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
End Date
Beschrijving

End Date

Datatype

date

Alias
UMLS CUI [1]
C0806020
continuing
Beschrijving

continuing

Datatype

boolean

Alias
UMLS CUI [1]
C1553904
STUDY CONCLUSION FOR MENCEVAX™ ACWY FULL DOSE STAGE
Beschrijving

STUDY CONCLUSION FOR MENCEVAX™ ACWY FULL DOSE STAGE

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

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Specify total number of SAE's:
Beschrijving

number of SAE

Datatype

text

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

elimination criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
Did any elimination criteria become applicable during the study? If Yes, please specify
Beschrijving

elimination criteria

Datatype

text

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

withdrawn

Datatype

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
Major reason for withdrawal
Beschrijving

Major reason for withdrawal

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
Who made the decision:
Beschrijving

Decision:

Datatype

integer

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

Date of last contact

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
Was the subject in good condition at date of last contact
Beschrijving

Was the subject in good condition at date of last contact

Datatype

integer

Alias
UMLS CUI [1]
C0348080
Investigators signature
Beschrijving

Investigators signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Printed Investigators name
Beschrijving

Printed Investigators name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
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Similar models

GSK non-inferiority of Tritanrix Hepatitis B VISIT 3 NCT00290303

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Reminders
C1709896 (UMLS CUI-1)
Item Group
ELIMINATION CRITERIA
C0680251 (UMLS CUI-1)
Item Group
ADVERSE EVENTS
C0877248 (UMLS CUI-1)
Item Group
MEDICATION
C0013227 (UMLS CUI-1)
Item Group
CHECK FOR STUDY CONTINUATION
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Did the subject return for visit 3 ?
Item
Did the subject return for visit 3 ?
boolean
C0545082 (UMLS CUI [1])
Item
If no return because:
integer
C0545082 (UMLS CUI [1,1])
C1548100 (UMLS CUI [1,2])
no return
Code List
If no return because:
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other, please specify: (3)
no return other
Item
If no return because:
text
C0545082 (UMLS CUI [1,1])
C1548100 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item
Please tick who made the decision
integer
C0679006 (UMLS CUI [1])
Decision
Code List
Please tick who made the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
LABORATORY TESTS
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
blood sample date
Item
blood sample date
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item Group
concomitant vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
integer
C0042210 (UMLS CUI [1])
vaccine
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date. (2)
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
C0027365 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
Intradermal  (ID)
CL Item
Parenteral (PE)
CL Item
Inhalation  (IH)
CL Item
Oral (PO)
CL Item
Intramuscular  (IM)
CL Item
Subcutaneous (SC)
CL Item
Intravenous  (IV)
CL Item
Sublingual (SL)
CL Item
Intranasal  (NA)
CL Item
Transdermal (TD)
CL Item
Other  (OTH)
CL Item
Unknown (UNK)
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Item
Have any medications/treatments been administered during study period?
integer
C0013227 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Medication
Code List
Have any medications/treatments been administered during study period?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Trade / Generic Name
Item
Trade / Generic Name
text
C0027365 (UMLS CUI [1])
Medical Indication
Item
Medical Indication
text
C2315323 (UMLS CUI [1])
Prophylactic
Item
Medical Indication: Prophylactic?
boolean
C0199176 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
continuing
Item
continuing
boolean
C1553904 (UMLS CUI [1])
Item Group
STUDY CONCLUSION FOR MENCEVAX™ ACWY FULL DOSE STAGE
C1707478 (UMLS CUI-1)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
number of SAE
Item
Specify total number of SAE's:
text
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
elimination criteria
Item
Did any elimination criteria become applicable during the study? If Yes, please specify
boolean
C0680251 (UMLS CUI [1])
elimination criteria
Item
Did any elimination criteria become applicable during the study? If Yes, please specify
text
C0680251 (UMLS CUI [1])
withdrawn
Item
Was the subject withdrawn from the study?
boolean
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Major reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Major reason for withdrawal
Code List
Major reason for withdrawal
CL Item
Non Serious adverse event (AEX)
CL Item
Consent withdrawal not due to an adverse event (CWS)
CL Item
Lost to follow up (LFU)
CL Item
Migrated moved from the study area (MIG)
CL Item
Other (OTH)
CL Item
Protocol violation (PTV)
CL Item
Serious adverse event (SAE)
Item
Who made the decision:
integer
C0679006 (UMLS CUI [1])
Who made the decision:
Code List
Who made the decision:
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item
Was the subject in good condition at date of last contact
integer
C0348080 (UMLS CUI [1])
Was the subject in good condition at date of last contact
Code List
Was the subject in good condition at date of last contact
CL Item
No, Please give details in Adverse Events section. (1)
CL Item
Yes (2)
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Printed Investigators name
Item
Printed Investigators name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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