ID
32060
Beschreibung
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 details Elimination Criteria. They need to be checked at each visit prior to any other procedure, starting form Visit 2. Visit 2 -> Timing: Day 30, Age: 10 weeks +/- 1 week Visit 3 -> Timing: Day 45, Age: 12 weeks +/- 1 week Visit 4 -> Timing: Day 60, Age: 14 weeks +/- 1 week Visit 5 -> Timing: Day 75, Age: 16 weeks +/- 1 week Visit 6 -> Timing: Day 105, Age: 20 weeks +/- 1 week
Link
https://clinicaltrials.gov/ct2/show/NCT00139334
Stichworte
Versionen (1)
- 16.10.18 16.10.18 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
16. Oktober 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334
Elimination Criteria during the Study
- StudyEvent: ODM
Beschreibung
Elimination Criteria during the Study
Alias
- UMLS CUI-1
- C0680251
Beschreibung
previous RV GE
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0035870
- UMLS CUI [1,2]
- C0017160
Beschreibung
Diarrhea
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011991
Beschreibung
investigational or non-registered product (drug or vaccine)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0304229
- UMLS CUI [2,1]
- C0042210
- UMLS CUI [2,2]
- C1517586
Beschreibung
undefined item
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021081
Beschreibung
Vaccine administration within 14 days before/after study vaccination nor forseen in study protocol
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschreibung
Immunoglobulins or blood products during study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0371802
Beschreibung
immunosuppressive or immunodeficient condition, including HIV infection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C4048329
- UMLS CUI [2]
- C0021051
- UMLS CUI [3]
- C0019693
Ähnliche Modelle
Elimination Criteria during the Study
- StudyEvent: ODM
C0017160 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C2348563 (UMLS CUI [1,2])
C0371802 (UMLS CUI [2])
C0021051 (UMLS CUI [2])
C0019693 (UMLS CUI [3])