NCT01825200 is a Phase 3 clinical trial of Flublok in Influenza, sponsored by Protein Sciences Corporation.

Who is sponsoring NCT01825200?

NCT01825200 is sponsored by Protein Sciences Corporation.

What drugs are being tested in NCT01825200?

Interventions in NCT01825200: Flublok, Afluria.

Is NCT01825200 still recruiting?

NCT01825200 is currently completed. Last updated 29 January 2015.

Are results published for NCT01825200?

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

Last reviewed 2015-01-29 · How we verify

NCT01825200

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

Comparison of the Safety of Flublok® Versus Licensed Inactivated Influenza Vaccine in Healthy, Medically Stable Adults ≥ 50 Years of Age

Completed Phase 3 Results posted Last updated 29 January 2015

What this trial tests

Phase 3 trial testing Flublok in Influenza in 2,640 participants. Completed in 1 May 2013.

Timeline

1 March 2013

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	Protein Sciences Corporation
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	2,640
Start date	1 March 2013
Primary completion	1 May 2013
Estimated completion	1 May 2013
Sites	14 locations across United States

Drugs / interventions tested

Flublok — full drug profile →
Afluria — full drug profile →

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

Protein Sciences Corporation — full company profile →

Who can join

50 and older, any sex, with Influenza. Healthy volunteers can join.

What's being measured

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

Number of Participants With Common Hypersensitivity Reactions as Measure of Safety
Time frame: 30 Days
Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.

Sponsor's own description

The hypothesis for this trial is that the incidence of a pre-defined composite of common systemic hypersensitivity adverse events for Flublok recipients is non-inferior to that reported for licensed IIV recipients. Another hypothesis is that the safety and reactogenicity of Flublok is clinically acceptable, i.e. consistent with the overall safety profiles previously observed with Flublok and with the licensed comparator.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Safety, efficacy, and immunogenicity of Flublok in the prevention of seasonal influenza in adults.
Cox MM, Izikson R, Post P, Dunkle L. · · 2015 · cited 104× · PMID 26478817 · DOI 10.1177/2051013615595595
Randomized comparison of the safety of Flublok(®) versus licensed inactivated influenza vaccine in healthy, medically stable adults ≥ 50 years of age.
Izikson R, Leffell DJ, Bock SA, Patriarca PA, et al · · 2015 · cited 21× · PMID 26529070 · DOI 10.1016/j.vaccine.2015.10.097

Verify or expand the search:

Other trials of Flublok

Trials testing the same drug.

NCT03722589 — Immunogenicity Trial of Egg- Versus Non-Egg-Based Influenza Vaccines Among HCP · Phase 4 · completed

Other recruiting trials for Influenza

Currently open trials in the same condition.

NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults · Phase 3 · recruiting
NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
NCT07431840 — Immune Defense Protein Impact On Respiratory Immune Outcomes · NA · recruiting
NCT07485855 — Influenza Vaccination Strategy for Patients With Hematologic Malignancy · Phase 3 · recruiting

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 NCT01825200 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Protein Sciences Corporation
Last refreshed: 29 January 2015

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/NCT01825200.

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