CClinicalTrials.gg
Sign In
CompletedNCT01010893Updated May 21, 2012

Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine

An interventional study of Vaccination with Fluval P and Fluval AB influenza vaccines and Vaccination with Fluval P monovalent influenza vaccine in Influenza, sponsored by Fluart Innovative Vaccine Ltd, Hungary. Completed at 2 sites in Hungary. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-21.

Sponsored by Fluart Innovative Vaccine Ltd, Hungary · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
355
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug.

Read the detailed description

Primary Objective:

To assess tolerability/safety (incidence of adverse events) of the study drug. To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21-28 after immunization in groups and age groups.

Secondary Objectives:

To assess the long-term safety of the study drug 50-60 days after immunization. To determine the tolerability of simultaneous administration of FLUVAL P monovalent pandemic influenza vaccine and FLUVAL AB trivalent seasonal influenza vaccine in case of adults and elderly people.

To assess the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season.

To assess the immunogenicity of the study drug by optional cross-reactive immunity tests performed with non-homologous influenza A and B virus strains.

02

Conditions studied

  • Influenza

Browse trials for

Keywords

  • pandemic
  • prevention
  • influenza
  • infection
  • influenza vaccine
  • vaccine
  • influenza in humans
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 355 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Fluart Innovative Vaccine Ltd, Hungary is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults aged 18 to 60 years, elderly people aged over 60 years, from both sexes, with full contractual capacity;
  • Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study;
  • Femal volunteers of childbearing potential with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method or abstinence throughout the trial and not become pregnant for the duration of the study.
  • Capable of understanding and complying with study protocol requirements;
  • The volunteers provide written informed consent prior to initiation of study procedures;
  • Absence of existence of any exclusion criteria.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or breast feeding or positive urine pregnancy test at baseline prior to vaccination;
  • Known allergy to eggs or other components of the vaccine (in particular mercury);
  • History of Guillain-Barré syndrome;
  • Active neoplasm;
  • Immunosuppressive therapy in the preceding 36 months;
  • Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
  • Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
  • Documented HIV, HBV or HCV infection;
  • Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immunoresponse;
  • Acute febrile respiratory illness within one week prior to vaccination;
  • Vaccine therapy within 4 weeks prior to vaccination;
  • Influenza vaccination within 6 months prior to vaccination;
  • Experimental drug therapy within 1 month prior to vaccination;
  • Past or current psychiatric disease of the volunteer that upon judgement of the investigator may have effect on the objective decision-making of the volunteer;
  • Alcohol or drug abuse of the participant.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
355 participants (actual)

Study arms

  • Experimental
    Influenza vaccination

    Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose).

    Biological: Vaccination with Fluval P monovalent influenza vaccine

  • Experimental
    Influenza vaccination and co-vaccination

    Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).

    Biological: Vaccination with Fluval P and Fluval AB influenza vaccines

Interventions

  • BiologicalVaccination with Fluval P and Fluval AB influenza vaccines

    Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).

    Also known as: Influenza, Pandemic vaccine, Seasonal vaccine, Co-vaccination, Prevention, Innfluenza vaccine, Influenza in humans

  • BiologicalVaccination with Fluval P monovalent influenza vaccine

    Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant

    Also known as: pandemic, influenza, prevention, vaccine, influenza vaccine, influenza in humans

06

What researchers measure

Primary outcomes

  1. Post vaccination HI antibody titer

    Time frame: 21-28 days after vaccination

  2. Incidence of adverse reactions

    Time frame: 21-28 days after vaccination

Secondary outcomes

  1. Incidence of adverse reactions

    Time frame: 50-60 days after vaccination

07

Study locations

2 sites
  • District Doctor's Office
    Pilisvorosvar, H-2085, Hungary
  • Fourmed Kft. Gyogyhaz
    Veszprem, H-8200, Hungary
08

References and documents

Publications

  • Vajo Z, Tamas F, Sinka L, Jankovics I. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet. 2010 Jan 2;375(9708):49-55. doi: 10.1016/S0140-6736(09)62039-0. Epub 2009 Dec 15. PubMed 20018367 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01010893
Lead sponsor
Fluart Innovative Vaccine Ltd, Hungary
Responsible party
Sponsor
First posted
Nov 10, 2009
Start date
Aug 2009
Primary completion
Sep 2009
Completion
Feb 2010
Last update
May 21, 2012

Study contacts

Ferenc Tamas, MD
principal investigator · Pilisvorosvar District Doctor's Office
Anna Osi, Dr.
study director · Omninvest Ltd.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Influenza, Human→

Other studies from this sponsor

Fluart Innovative Vaccine Ltd, Hungary

Start the discussion