ID
32445
Description
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
Keywords
Versions (1)
- 11/1/18 11/1/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 1, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644
Study Conclusion
- StudyEvent: ODM
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
Occurrence of Serious Adverse Event
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Total number of Serious Adverse Events
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Description
If yes, fill out date and tick one reason
Data type
boolean
Alias
- UMLS CUI [1]
- C3897431
Description
If treatment blind broken
Data type
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Description
Complete the Serious Adverse Event report as appropriate.
Data type
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Description
Complete the Serious Adverse Event report as appropriate
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
Description
Elimination Criteria Applicable
Data type
boolean
Alias
- UMLS CUI [1]
- C0680251
Description
If Elimination Criteria applicable, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Description
Study Withdrawal
Alias
- UMLS CUI-1
- C0422727
Description
Was the subject withdrawn?
Data type
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
Tick one box only
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Description
Serious Adverse Event Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
Non-serious adverse Event Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
if protocol violation, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Description
Other reason for withdrawal
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
Description
Party Responsible for Decision
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
- UMLS CUI [1,3]
- C0680379
Description
Date of last contact
Data type
date
Alias
- UMLS CUI [1]
- C0805839
Description
Subject Condition at Date of Last Contact
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0805839
- UMLS CUI [1,2]
- C1142435
Description
If no, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0805839
- UMLS CUI [1,2]
- C1142435
- UMLS CUI [1,3]
- C2348235
Description
Signature
Alias
- UMLS CUI-1
- C1519316
Description
Investigator's signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator's signature date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Study Conclusion
- StudyEvent: ODM
C0449788 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,2])
C0680379 (UMLS CUI [1,3])
C1142435 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])