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NCT03954743 · ClinicalTrials.gov registry record · Phase 3
Safety Study of 2 Formulations of GSK's 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
- 1,351
- Enrollment target
NCT03954743 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,351 participants.
The verdict
NCT03954743, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,351 participants
- Enrollment target
Study Summary
The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan. This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored frozen in order to keep the titer stable until administration during the study. As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized formulation of the vaccine was used as a control in all phase III studies as part of the PCV-free development plan.
Interventions
- BIOLOGICAL PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine
- BIOLOGICAL Lyophilized formulation of GSK's oral live attenuated HRV vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,351 participants |
| Start Date | 2019-07-19 |
| Est. Completion | 2020-11-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03954743
The ClinicalTrials.gov registry entry for NCT03954743 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,351 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 PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine is the first listed.
NCT03954743 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03954743 about?
NCT03954743 is a clinical study titled "Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks". The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan. This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper ran...
What is the current status of trial NCT03954743?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,351 participants. The study started on 2019-07-19. Estimated completion is 2020-11-30.
What interventions are being tested in trial NCT03954743?
The interventions under investigation include: PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine (BIOLOGICAL), Lyophilized formulation of GSK's oral live attenuated HRV vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03954743?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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