ID

32088

Beskrivning

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form is to be filled in at study conclusion (whether it is regular or preterm)

Länk

https://clinicaltrials.gov/ct2/show/NCT00139334

Nyckelord

Versioner (1)
  1. 2018-10-17 2018-10-17 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 oktober 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

Engelsk

Study Conclusion

1 Formulär  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Occurrence of Serious Adverse Event
Beskrivning

Occurrence of Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event during the study period ?
Beskrivning

If yes, specify total number of SAE's in the following item.

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
Number of serious adverse events
Beskrivning

Number of serious adverse events

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Status of treatment blind
Beskrivning

Status of treatment blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
UMLS CUI-3
C3897431
Was the treatment blind broken during the study?
Beskrivning

if yes, complete date and tick one reason below / fill out the following items.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C3897431
Date of break of treatment blind
Beskrivning

Date of break of treatment blind

Datatyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason for breaking treatment blind
Beskrivning

Complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate.

Datatyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Other reason for breaking treatment blind, specify:
Beskrivning

Other reason for breaking treatment blind

Datatyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C3845569
UMLS CUI [1,3]
C0392360
Elimination Criteria
Beskrivning

Elimination Criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable during the study ?
Beskrivning

If yes, specify in the following item.

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
Elimination criteria, specify:
Beskrivning

Elimination criteria, specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Withdrawal from Study
Beskrivning

Withdrawal from Study

Alias
UMLS CUI-1
C0422727
Was the subject withdrawn from study?
Beskrivning

If yes, please tick the one most appropriate category for withdrawal in the following item.

Datatyp

boolean

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

Reason for withdrawal from study

Datatyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0566251
If SAE, please specify SAE number
Beskrivning

SAE number

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349022
If unsolicited non-serious AE, please specify uncolicited AE number
Beskrivning

If solicited non-serious adverse event, please complete the solicited AE code item.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C4055646
If solicited AE, please specify solicited AE code:
Beskrivning

If unsolicited non-serious adverse event, please complete the unsolicited AE number item.

Datatyp

text

Alias
UMLS CUI [1,1]
C1517001
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0805701
If protocol violation, please specify
Beskrivning

Protocol violation

Datatyp

text

Alias
UMLS CUI [1]
C1709750
Other category, please specify:
Beskrivning

Other reason for withdrawal

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Please tick who took the decision:
Beskrivning

Person to decide about withdrawal

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
If withdrawn, Date of last contact
Beskrivning

Date of last contact

Datatyp

date

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

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Investigator's signature
Beskrivning

Investigator's signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data 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. Investigator's Signature
Beskrivning

Investigator's signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beskrivning

Date of signature

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed investigator's name
Beskrivning

Printed investigator's name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study Conclusion

1 Formulär
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Occurrence of Serious Adverse Event
C1519255 (UMLS CUI-1)
Occurence or serious adverse events
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
Number of serious adverse events
Item
Number of serious adverse events
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
Status of treatment blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
C3897431 (UMLS CUI-3)
Status of treatment blind
Item
Was the treatment blind broken during the study?
boolean
C2347038 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,3])
Date of break of treatment blind
Item
Date of break of treatment blind
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason for breaking treatment blind
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason from breaking treatment blind
Code List
Reason for breaking treatment blind
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (9)
Other reason for breaking treatment blind
Item
Other reason for breaking treatment blind, specify:
text
C3897431 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
Elimination Criteria
C0680251 (UMLS CUI-1)
Elimination Criteria
Item
Did any elimination criteria become applicable during the study ?
boolean
C0680251 (UMLS CUI [1])
Elimination criteria, specification
Item
Elimination criteria, specify:
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Withdrawal from Study
C0422727 (UMLS CUI-1)
Withdrawal 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
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason for withdrawal from study
Code List
Please tick the ONE most appropriate category for withdrawal.
CL Item
Serious adverse event (Check Serious adverse Event form and specify SAE number below). (SAE)
CL Item
Non-serious adverse event (Check the Non-serious adverse Event section and specify unsolicited AE number or solicited AE code below) (AEX)
CL Item
protocol viloation (please specify below) (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 below) (OTH)
SAE number
Item
If SAE, please specify SAE number
integer
C1519255 (UMLS CUI [1,1])
C2349022 (UMLS CUI [1,2])
unsolicited AE number
Item
If unsolicited non-serious AE, please specify uncolicited AE number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
Solicited AE code
Item
If solicited AE, please specify solicited AE code:
text
C1517001 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Protocol violation
Item
If protocol violation, please specify
text
C1709750 (UMLS CUI [1])
Other reason for withdrawal
Item
Other category, please specify:
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Please tick who took the decision:
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Person to decide about withdrawal
Code List
Please tick who took the decision:
CL Item
investigator (I)
CL Item
parents/guardians (P)
Date of last contact
Item
If withdrawn, Date of last contact
date
C0805839 (UMLS CUI [1])
Condition at 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])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
I confirm that I have reviewed the data 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. Investigator's Signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed investigator's name
Item
Printed investigator's name
text
C2826892 (UMLS CUI [1])
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