NCT01010893

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

1 month

First QC Date

November 7, 2009

Last Update Submit

May 18, 2012

Conditions

Influenza

Keywords

pandemicpreventioninfluenzainfectioninfluenza vaccinevaccineinfluenza in humans

Outcome Measures

Primary Outcomes (2)

  • Post vaccination HI antibody titer

    21-28 days after vaccination

  • Incidence of adverse reactions

    21-28 days after vaccination

Secondary Outcomes (1)

  • Incidence of adverse reactions

    50-60 days after vaccination

Study Arms (2)

Influenza vaccination

EXPERIMENTAL

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

Influenza vaccination and co-vaccination

EXPERIMENTAL

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

Vaccination with Fluval P and Fluval AB influenza vaccinesBIOLOGICAL

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
Influenza vaccination and co-vaccination
Vaccination with Fluval P monovalent influenza vaccineBIOLOGICAL

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
Influenza vaccination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

District Doctor's Office

Pilisvörösvár, H-2085, Hungary

Location

Fourmed Kft. Gyogyhaz

Veszprém, H-8200, Hungary

Location

Related Publications (1)

  • 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.

    PMID: 20018367DERIVED

MeSH Terms

Conditions

Influenza, HumanInfections

Interventions

VaccinationInfluenza VaccinesPandemicsVaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public HealthViral VaccinesBiological ProductsComplex MixturesEpidemicsDisease Outbreaks

Study Officials

  • Ferenc Tamas, MD

    Pilisvorosvar District Doctor's Office

    PRINCIPAL INVESTIGATOR

  • Anna Osi, Dr.

    Omninvest Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2009

First Posted

November 10, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2009

Study Completion

February 1, 2010

Last Updated

May 21, 2012

Record last verified: 2012-05

Locations

HU(2)