ID

32082

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 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 gastroenteritis episodes between visits 3 and 4, 4 and 5 as well as 5 and 6, starting 1 week after dose 1 of HRV/Placebo in Visit 3). To be assessed at Visits 4, 5 and 6. 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

Keywords

Versions (1)

1. 10/17/18 10/17/18 - Sarah Riepenhausen

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GlaxoSmithKline

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October 17, 2018

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