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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: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02914184 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,612 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (109% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Antibody concentrations against Rota Virus (RV) were determined as Geometric Mean Antibody Concentration (GMC) and expressed as Units per milliliter (U/mL).
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 |
What the finished NCT02914184 record still lists
NCT02914184 is an interventional study that assigns participants to a tested intervention. Its 1,612 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 (109% higher).
The record links to 0 conditions, and to 2 interventions - of which Rotarix is the first listed.
NCT02914184 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02914184's enrollment target sits among peer trials
1,612 142nd of 2000 higher than 1,859 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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