ID
32072
Beschrijving
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?term=NCT00139334&rank=1 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 contains the trial's Eligibility Criteria. To be filled in at visit 1, prior to any study procedures. Timing: Day 0 Age: 6 weeks +/- 1 day
Link
https://clinicaltrials.gov/ct2/show/NCT00139334?term=NCT00139334&rank=1
Trefwoorden
Versies (2)
- 16-10-18 16-10-18 - Sarah Riepenhausen
- 16-10-18 16-10-18 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 oktober 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334
Eligibility Criteria
- StudyEvent: ODM
Beschrijving
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Beschrijving
Inclusion criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. (1)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0030551
Beschrijving
A male or female between, and including, 6 weeks +/- 1 week of age at the tiem of Visit 1. (2)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Written informed consent obtained from the parent or guardian of the subject. (3)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Free of obvious health problems as established by medical history and clinical examination before entering into the study. (4)
Datatype
boolean
Alias
- UMLS CUI [1]
- C1446390
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. (5)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013230
Beschrijving
Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after. (6)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042196
Beschrijving
Chronic administration (defined as more than 14 days) of major immunosuppressants (equivalent to prednisone 1mg/kg/day) since birth. (Topical steroids are allowed.) (7)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C2347852
Beschrijving
Malnutrition (< 3Z score weight for age). (8)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0162429
Beschrijving
History of/or intercurrent polio disease. (9)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032371
Beschrijving
Previous confirmed occurrence of RV GE. (10)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0017160
- UMLS CUI [1,2]
- C0035870
Beschrijving
History of use of experimental RV vaccine. (11)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0597418
Beschrijving
Previous routine vaccination except BCG, HBV and OPV vaccination at birth (should be documented in the CRF). (12)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0679831
Beschrijving
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator. (13)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0017178
- UMLS CUI [2,1]
- C4023588
- UMLS CUI [2,2]
- C4072785
- UMLS CUI [3,1]
- C3843040
- UMLS CUI [3,2]
- C0205404
Beschrijving
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (14)
Datatype
boolean
Alias
- UMLS CUI [1]
- C3829792
- UMLS CUI [2]
- C4048329
- UMLS CUI [3]
- C0019693
Beschrijving
History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. (15)
Datatype
boolean
Alias
- UMLS CUI [1]
- C2106654
Beschrijving
Acute disease at the time of enrolment. (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).) (16)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001314
Beschrijving
A family history of congenital or hereditary immunodeficiency. (17)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C0853602
- UMLS CUI [2,1]
- C0241889
- UMLS CUI [2,2]
- C0439660
- UMLS CUI [2,3]
- C0021051
Beschrijving
Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. (18)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0456388
Beschrijving
History of any neurologic disorders or seizures. (19)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027765
- UMLS CUI [2]
- C0036572
Beschrijving
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. (20)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0231921
- UMLS CUI [2]
- C0678859
- UMLS CUI [3]
- C0232804
- UMLS CUI [4]
- C0232741
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0030551 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0035870 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,2])
C0679831 (UMLS CUI [1,2])
C4023588 (UMLS CUI [2,1])
C4072785 (UMLS CUI [2,2])
C3843040 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C4048329 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0853602 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0021051 (UMLS CUI [2,3])
C0456388 (UMLS CUI [2])
C0036572 (UMLS CUI [2])
C0678859 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232741 (UMLS CUI [4])