ID

32065

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 Routine Vaccinations of OPV and DTPw-HB during the study. To be filled in according to the following scheme: Visit 1 -> Timing: Day 0, Age 6 weeks +/- 1 week; both vaccines for all subjects Visit 2 -> Timing: Day 30, Age 10 weeks +/- 1 week; DTPw-HB for all subjects, OPV only for subset "HRV(-PI) alone" Visit 3 -> Timing: Day 45, Age 12 weeks +/- 1 week; no DTPw-HB for any subject, OPV only for subset "HRV(-PI) + OPV" Visit 4 -> Timing: Day 60, Age 14 weeks +/- 1 week; DTPw-HB for all subjects, OPV only for subset "HRV(-PI) alone" Visit 5 -> Timing: Day 75, Age 16 weeks +/- 1 week; no DTPw-HB for any subject, OPV only for subset "HRV(-PI) + OPV"

Link

https://clinicaltrials.gov/ct2/show/NCT00139334

Keywords

Versions (1)

1. 10/16/18 10/16/18 - Sarah Riepenhausen

Copyright Holder

GlaxoSmithKline

Uploaded on

October 16, 2018

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