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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: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT03954743 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,351 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurre
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 |
What the finished NCT03954743 record still lists
NCT03954743 is an interventional study that assigns participants to a tested intervention. Its 1,351 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03954743's enrollment target sits among peer trials
1,351 181st of 2000 higher than 1,820 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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