ID
32446
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 Eligibility criteria for study. To be checked at first 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
Eligibility Criteria
- StudyEvent: ODM
Description
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Parents Protocol Compliance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0525058
- UMLS CUI [1,2]
- C0030551
Description
Gender, Age
Data type
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2,1]
- C0001779
- UMLS CUI [2,2]
- C0021270
Description
Informed Consent Guardian or parents
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1274041
- UMLS CUI [2,1]
- C0021430
- UMLS CUI [2,2]
- C0030551
Description
Subject Healthy
Data type
boolean
Alias
- UMLS CUI [1]
- C3898900
- UMLS CUI [2]
- C0262926
- UMLS CUI [3]
- C0031809
Description
Birth weight
Data type
boolean
Alias
- UMLS CUI [1]
- C0005612
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Use of investigational drug or vaccine
Data type
boolean
Alias
- UMLS CUI [1]
- C0013230
- UMLS CUI [2,1]
- C0013230
- UMLS CUI [2,2]
- C0042210
- UMLS CUI [3,1]
- C0332300
- UMLS CUI [3,2]
- C1521826
- UMLS CUI [3,3]
- C0042210
Description
Concurrently participating in another clinical study with exposure to investigational drug
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [2,1]
- C2348568
- UMLS CUI [2,2]
- C0013227
Description
Planned administration of other vaccine
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0205394
Description
Chronic administration of immunosuppressants except topical steroids
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C1515119
- UMLS CUI [2,1]
- C0332300
- UMLS CUI [2,2]
- C0038317
- UMLS CUI [2,3]
- C1522168
Description
History of use of experimental rotavirus vaccine
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1517586
- UMLS CUI [1,3]
- C0597418
Description
Previous routine vaccination except BCG, HBV and OPV
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0332300
- UMLS CUI [2,2]
- C0004886
- UMLS CUI [3,1]
- C0332300
- UMLS CUI [3,2]
- C0474232
- UMLS CUI [4,1]
- C0332300
- UMLS CUI [4,2]
- C0032375
Description
History of gastrointestinal disease
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0017178
- UMLS CUI [1,2]
- C0750502
- UMLS CUI [1,3]
- C0262926
- UMLS CUI [2,1]
- C0017189
- UMLS CUI [2,2]
- C0000768
- UMLS CUI [3]
- C0021933
- UMLS CUI [4,1]
- C0009488
- UMLS CUI [4,2]
- C0205082
Description
Immunodeficient condition based on medical history or physical examination
Data type
boolean
Alias
- UMLS CUI [1,1]
- C4048329
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [2,1]
- C4048329
- UMLS CUI [2,2]
- C0031809
Description
History of allergic disease
Data type
boolean
Alias
- UMLS CUI [1]
- C2106654
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C0013230
Description
(Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).) (warrants deferral of vaccination).
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0001314
- UMLS CUI [1,2]
- C0205081
- UMLS CUI [2,1]
- C0001314
- UMLS CUI [2,2]
- C0205082
Description
Recent Gastroenteritis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0017160
- UMLS CUI [1,2]
- C0332185
Description
Recent Rotavirus Gastroenteritis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035870
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0017160
Description
Family history of congenital or hereditary immunodeficiency
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C0853602
- UMLS CUI [2,1]
- C0241889
- UMLS CUI [2,2]
- C0021051
- UMLS CUI [2,3]
- C0439660
Description
History of or planned administration of immunoglobulins or blood products
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0021027
- UMLS CUI [2,1]
- C1301732
- UMLS CUI [2,2]
- C0021027
- UMLS CUI [3,1]
- C0262926
- UMLS CUI [3,2]
- C0456388
- UMLS CUI [4,1]
- C1301732
- UMLS CUI [4,2]
- C0456388
Description
History of neurologic disorders or seizures
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0036572
Description
pulmonary, cardiovascular, hepatic or renal dysfunction
Data type
boolean
Alias
- UMLS CUI [1]
- C0086565
- UMLS CUI [2]
- C3279454
- UMLS CUI [3]
- C0007222
- UMLS CUI [4]
- C0024115
- UMLS CUI [5]
- C0031809
- UMLS CUI [6]
- C0587081
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0030551 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2,1])
C0021270 (UMLS CUI [2,2])
C1274041 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0013230 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C1521826 (UMLS CUI [3,2])
C0042210 (UMLS CUI [3,3])
C0013230 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0038317 (UMLS CUI [2,2])
C1522168 (UMLS CUI [2,3])
C1517586 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0004886 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0474232 (UMLS CUI [3,2])
C0332300 (UMLS CUI [4,1])
C0032375 (UMLS CUI [4,2])
C0750502 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0017189 (UMLS CUI [2,1])
C0000768 (UMLS CUI [2,2])
C0021933 (UMLS CUI [3])
C0009488 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0262926 (UMLS CUI [1,2])
C4048329 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0205081 (UMLS CUI [1,2])
C0001314 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332185 (UMLS CUI [1,2])
C0035870 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0017160 (UMLS CUI [2,2])
C0853602 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0021051 (UMLS CUI [2,2])
C0439660 (UMLS CUI [2,3])
C0021027 (UMLS CUI [1,2])
C1301732 (UMLS CUI [2,1])
C0021027 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0456388 (UMLS CUI [3,2])
C1301732 (UMLS CUI [4,1])
C0456388 (UMLS CUI [4,2])
C0027765 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0036572 (UMLS CUI [2,2])
C3279454 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0587081 (UMLS CUI [6])