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NCT02914184 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,612
- Enrollment target
NCT02914184 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,612 participants.
The verdict
NCT02914184, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,612 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.
Interventions
- BIOLOGICAL Rotarix
- BIOLOGICAL HRV PCV-free liquid vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,612 participants |
| Start Date | 2016-10-27 |
| Est. Completion | 2018-11-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02914184
The ClinicalTrials.gov registry entry for NCT02914184 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,612 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rotarix is the first listed.
NCT02914184 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02914184 about?
NCT02914184 is a clinical study titled "Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks". The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently license...
What is the current status of trial NCT02914184?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,612 participants. The study started on 2016-10-27. Estimated completion is 2018-11-26.
What interventions are being tested in trial NCT02914184?
The interventions under investigation include: Rotarix (BIOLOGICAL), HRV PCV-free liquid vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02914184?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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