ID

32445

Beschrijving

Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form concludes the study and should be filled out at the last visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00241644

Trefwoorden

Versies (1)
  1. 01-11-18 01-11-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

1 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

Engels

Study Conclusion

1 Formulieren  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
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

Occurrence of Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
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
Was the treatment blind broken during the study?
Beschrijving

If yes, fill out date and tick one reason

Datatype

boolean

Alias
UMLS CUI [1]
C3897431
Status of Treatment Blind Broken Date
Beschrijving

If treatment blind broken

Datatype

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason for Treatment Blind Broken
Beschrijving

Complete the Serious Adverse Event report as appropriate.

Datatype

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Other reason for Treatment Blind Broken
Beschrijving

Complete the Serious Adverse Event report as appropriate

Datatype

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
Did any elimination criteria become applicable during the study?
Beschrijving

Elimination Criteria Applicable

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
Why did any elimination criteria became applicable?
Beschrijving

If Elimination Criteria applicable, specify

Datatype

text

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

Study Withdrawal

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

Was the subject withdrawn?

Datatype

boolean

Alias
UMLS CUI [1]
C0422727
Major reason for withdrawal .
Beschrijving

Tick one box only

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
SAE No.
Beschrijving

Serious Adverse Event Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE No.
Beschrijving

Non-serious adverse Event Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Specification of protocol violation
Beschrijving

if protocol violation, please specify

Datatype

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
Other reason for withdrawal
Beschrijving

Other reason for withdrawal

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
Who made the decision to withdraw the subject?
Beschrijving

Party Responsible for Decision

Datatype

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0680379
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

Subject Condition at Date of Last Contact

Datatype

boolean

Alias
UMLS CUI [1,1]
C0805839
UMLS CUI [1,2]
C1142435
Specify the condition at date of last contact?
Beschrijving

If no, please specify

Datatype

text

Alias
UMLS CUI [1,1]
C0805839
UMLS CUI [1,2]
C1142435
UMLS CUI [1,3]
C2348235
Signature
Beschrijving

Signature

Alias
UMLS CUI-1
C1519316
Investigator's signature
Beschrijving

Investigator's signature

Datatype

text

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

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

Study Conclusion

1 Formulieren
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Occurrence of Serious Adverse Event
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
Total number of Serious Adverse Events
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Status of Treatment Blind
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Status of Treatment Blind Broken Date
Item
Status of Treatment Blind Broken Date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason for Treatment Blind Broken
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for Treatment Blind Broken
Code List
Reason for Treatment Blind Broken
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (9)
Other reason for Treatment Blind Broken
Item
Other reason for Treatment Blind Broken
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Elimination Criteria Applicable
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
Specification of Elimination Criteria
Item
Why did any elimination criteria became applicable?
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Study Withdrawal
C0422727 (UMLS CUI-1)
Was the subject withdrawn?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Major reason for withdrawal .
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Major reason for study withdrawal
Code List
Major reason for withdrawal .
CL Item
serious adverse event ([SAE])
CL Item
Non-serious adverse event ([AEX])
CL Item
Protocol violation ([PTV])
CL Item
Consent withdrawal, not due to an advere event ([CWS])
CL Item
Migrated/moved from the study area ([MIG])
CL Item
Lost to follow-up ([LFU])
CL Item
Other ([OTH])
Serious Adverse Event Number
Item
SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-serious adverse Event Number
Item
AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specification of protocol violation
Item
Specification of protocol violation
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other reason for withdrawal
Item
Other reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Who made the decision to withdraw the subject?
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0680379 (UMLS CUI [1,3])
Party Responsible for Decision
Code List
Who made the decision to withdraw the subject?
CL Item
Investigator ([I])
CL Item
Subject ([S])
CL Item
Parents ([P])
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Subject Condition at Date of Last Contact
Item
Was the subject in good condition at date of last contact?
boolean
C0805839 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
Specification of Subject Condition
Item
Specify the condition at date of last contact?
text
C0805839 (UMLS CUI [1,1])
C1142435 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
C1519316 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
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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