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: Completed Phase 3 study, sponsored by Novartis Vaccines.
NCT02256488 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 1,561 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
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 |
What the finished NCT02256488 record still lists
NCT02256488 is an interventional study that assigns participants to a tested intervention. Its 1,561 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 (102% higher).
The record links to 0 conditions, and to 4 interventions - of which TIVc_LOT A is the first listed.
NCT02256488 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02256488's enrollment target sits among peer trials
1,561 150th of 2000 higher than 1,851 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06881069 · 1,560 participants · NA
Reach Through Equitable Implementation in Utah
- NCT06034080 · 1,566 participants · NA
Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
- NCT06445946 · 1,572 participants · Phase 4
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
- NCT02650622 · 1,550 participants
Genetic and Metabolic Disease in Children
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia