Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02256488 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
A Phase 3 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,561
- Enrollment target
NCT02256488 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 1,561 participants.
The verdict
NCT02256488, a Phase 3 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,561 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf). The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study. The total study participation time per subject is about 3 weeks.
Interventions
- BIOLOGICAL TIVc_LOT A
- BIOLOGICAL TIVc_LOT B
- BIOLOGICAL TIVc_LOT C
- BIOLOGICAL TIVf
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,561 participants |
| Start Date | 2014-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02256488
The ClinicalTrials.gov registry entry for NCT02256488 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,561 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Vaccines, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which TIVc_LOT A is the first listed.
NCT02256488 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02256488 about?
NCT02256488 is a clinical study titled "Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects". The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf). The study comp...
What is the current status of trial NCT02256488?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,561 participants. The study started on 2014-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02256488?
The interventions under investigation include: TIVc_LOT A (BIOLOGICAL), TIVc_LOT B (BIOLOGICAL), TIVc_LOT C (BIOLOGICAL), TIVf (BIOLOGICAL).
Who is sponsoring clinical trial NCT02256488?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.