ID

24716

Beskrivning

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 INTER-VISIT CONTACT 1 form

Nyckelord

Versioner (1)
  1. 2017-08-14 2017-08-14 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

14 augusti 2017

DOI

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Creative Commons BY-NC 3.0
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GSK non-inferiority of Tritanrix Hepatitis B INTER-VISIT CONTACT 1 NCT00290303

Engelsk

GSK non-inferiority of Tritanrix Hepatitis B INTER-VISIT CONTACT 1 NCT00290303

1 Formulär  
CHECK FOR STUDY CONTINUATION
Beskrivning

CHECK FOR STUDY CONTINUATION

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

Did the subject return for inter visit contact 1 ?

Datatyp

boolean

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

no return

Datatyp

integer

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

no return other

Datatyp

text

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

Decision

Datatyp

integer

Alias
UMLS CUI [1]
C0679006
PROTOCOL REQUIRED CONCOMITANT VACCINATION
Beskrivning

PROTOCOL REQUIRED CONCOMITANT VACCINATION

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
UMLS CUI-3
C0078048
Have the VARICELLA incentive vaccine been administered ?
Beskrivning

administered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0078048
UMLS CUI [1,2]
C3469597
Please complete only if different from visit date:
Beskrivning

different from visit date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

GSK non-inferiority of Tritanrix Hepatitis B INTER-VISIT CONTACT 1 NCT00290303

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
CHECK FOR STUDY CONTINUATION
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Did the subject return for inter visit contact 1 ?
Item
Did the subject return for inter visit contact 1 ?
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
PROTOCOL REQUIRED CONCOMITANT VACCINATION
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0078048 (UMLS CUI-3)
administered
Item
Have the VARICELLA incentive vaccine been administered ?
boolean
C0078048 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
different from visit date
Item
Please complete only if different from visit date:
date
C0011008 (UMLS CUI [1])
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