ID
32071
Description
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 is for documentation of demographics, informed consent and randomization/treatment number. To be filled in at Visit 1. Timing: Day 0 Age: 6 weeks +/- 1 week
Link
https://clinicaltrials.gov/ct2/show/NCT00139334?term=NCT00139334&rank=1
Keywords
Versions (2)
- 10/16/18 10/16/18 - Sarah Riepenhausen
- 10/16/18 10/16/18 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
October 16, 2018
DOI
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License
Creative Commons BY-NC 3.0
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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334
Demographics and Administrative Data
- StudyEvent: ODM
Description
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Center number
Data type
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Race
Data type
integer
Alias
- UMLS CUI [1]
- C0034510
Description
Other Race
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Randomisation/Treatment Allocation
Alias
- UMLS CUI-1
- C0034656
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Demographics and Administrative Data
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])