ID
32069
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 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 is for documentation of planned stool samples for the "stool subset". To be filled in at visit 3 (prior to and after first dose of study vaccine) and at visit 5 (prior and after second dose of study vaccine). Visit 3, Vaccination 1 -> Timing: Day 45, Age: 12 weeks +/- 1 week Visit 5, Vaccination 2 -> Timing: Day 75, Age: 16 weeks +/- 1 week This is not for documentation of stool samples in case of a gastroenteritis episode. Please use the Stool Collection form in that case.
Link
https://clinicaltrials.gov/ct2/show/NCT00139334
Trefwoorden
Versies (1)
- 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
Planned stool samples
- StudyEvent: ODM
Beschrijving
Laboratory tests: Planned stool samples (only for a subset of subjects)
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C1550661
- UMLS CUI-3
- C1301732
Beschrijving
Stool sample prior to vaccination
Datatype
text
Alias
- UMLS CUI [1,1]
- C1550661
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0597418
Beschrijving
Date of Stool sample prior to vaccination
Datatype
date
Alias
- UMLS CUI [1,1]
- C1550661
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0597418
- UMLS CUI [1,4]
- C1302413
Beschrijving
Stool sample 3-5 days after vaccination
Datatype
text
Alias
- UMLS CUI [1,1]
- C1550661
- UMLS CUI [1,2]
- C0231290
- UMLS CUI [1,3]
- C0597418
Beschrijving
Date of Stool sample 3-5 days after vaccination
Datatype
date
Alias
- UMLS CUI [1,1]
- C1550661
- UMLS CUI [1,2]
- C0231290
- UMLS CUI [1,3]
- C0597418
- UMLS CUI [1,4]
- C1302413
Beschrijving
Stool sample 6-8 days after vaccination
Datatype
text
Alias
- UMLS CUI [1,1]
- C1550661
- UMLS CUI [1,2]
- C0231290
- UMLS CUI [1,3]
- C0597418
Beschrijving
Date of Stool sample 6-8 days after vaccination
Datatype
date
Alias
- UMLS CUI [1,1]
- C1550661
- UMLS CUI [1,2]
- C0231290
- UMLS CUI [1,3]
- C0597418
- UMLS CUI [1,4]
- C1302413
Similar models
Planned stool samples
- StudyEvent: ODM
C1550661 (UMLS CUI-2)
C1301732 (UMLS CUI-3)
C0332152 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])
C0231290 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
C0231290 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])
C0231290 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
C0231290 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])