NCT02256488 is a Phase 3 clinical trial of TIVc_LOT A in Prophylaxis: Influenza, sponsored by Novartis Vaccines.

Who is sponsoring NCT02256488?

NCT02256488 is sponsored by Novartis Vaccines.

What drugs are being tested in NCT02256488?

Interventions in NCT02256488: TIVc_LOT A, TIVc_LOT B, TIVc_LOT C, TIVf.

What condition does NCT02256488 study?

NCT02256488 studies Prophylaxis: Influenza.

Is NCT02256488 still recruiting?

NCT02256488 is currently completed. Last updated 28 May 2019.

Are results published for NCT02256488?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-05-28 · How we verify

NCT02256488

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

Completed Phase 3 Results posted Last updated 28 May 2019

What this trial tests

Phase 3 trial testing TIVc_LOT A in Prophylaxis: Influenza in 1,561 participants. Completed in 1 December 2014.

Timeline

1 September 2014

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	1,561
Start date	1 September 2014
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	24 locations across United States

Drugs / interventions tested

TIVc_LOT A — full drug profile →
TIVc_LOT B — full drug profile →
TIVc_LOT C — full drug profile →
TIVf — full drug profile →

Conditions studied

Prophylaxis: Influenza — all drugs for Prophylaxis: Influenza →

Sponsor

Novartis Vaccines — full company profile →

Who can join

Adults 18 to 49, any sex, with Prophylaxis: Influenza. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
Time frame: Day 22
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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02256488 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Vaccines
Last refreshed: 28 May 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02256488.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing