Who is sponsoring NCT00778297?

NCT00778297 is sponsored by Fluart Innovative Vaccine Ltd, Hungary.

What drugs are being tested in NCT00778297?

Interventions in NCT00778297: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine, Vaccination with FluvalAB trivalent influenza vaccine.

Is NCT00778297 still recruiting?

NCT00778297 is currently completed. Last updated 18 May 2012.

Last reviewed 2012-05-18 · How we verify

NCT00778297

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

Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content

Completed NA Last updated 18 May 2012

What this trial tests

NA trial testing Vaccination with FluvalAB FL-K-004 trivalent flu vaccine in Influenza in 234 participants. Completed in 1 May 2008.

Timeline

1 November 2007

Primary endpoint
1 January 2008

1 May 2008

Quick facts

Lead sponsor	Fluart Innovative Vaccine Ltd, Hungary
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	234
Start date	1 November 2007
Primary completion	1 January 2008
Estimated completion	1 May 2008
Sites	1 location across Hungary

Drugs / interventions tested

Vaccination with FluvalAB FL-K-004 trivalent flu vaccine — full drug profile →
Vaccination with FluvalAB trivalent influenza vaccine — full drug profile →

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

Fluart Innovative Vaccine Ltd, Hungary — full company profile →

Who can join

18 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.

Post-vaccination HI antibody titre
Time frame: 21-28 days after vaccination
Incidence of adverse reactions
Time frame: 21-28 days after vaccination

Sponsor's own description

This is a single blind, reference drug controlled, one center viral immunogenicity and tolerability study of FluvalAB FL-K-004 Trivalent Influenza Vaccine with 6 μg HA/strain/dos antigen content to assess immunogenicity and tolerability. The aim of the study is to assess the immunogenicity and tolerability of FluvalAB FL-K-004 trivalent influenza vaccine with 6 μg HA/strain/dos antigen content (study drug) in age groups 18-60 years and over 60 years, with the objective to verify efficacy and tolerability of the study drug according to CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A reduced-dose seasonal trivalent influenza vaccine is safe and immunogenic in adult and elderly patients in a randomized controlled trial.
Vajo Z, Tamas F, Jankovics I. · · 2012 · cited 5× · PMID 22219315 · DOI 10.1128/cvi.05619-11

Verify or expand the search:

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

Other Fluart Innovative Vaccine Ltd, Hungary trials

Trials by the same sponsor.

NCT03448705 — Safety of 4Fluart ID Suspension for Injection in Adult Subjects · Phase 1 · completed
NCT01863849 — Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection · Phase 4 · completed

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 NCT00778297 (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 Fluart Innovative Vaccine Ltd, Hungary
Last refreshed: 18 May 2012

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/NCT00778297.

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