Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine

Tolerability and Immunogenicity Study of FLUVAL P Monovalent Influenza Vaccine in Adults and Elderly Persons

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Vaccination with Fluval P monovalent influenza vaccine; Biological: Vaccination with Fluval P and Fluval AB influenza vaccines

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.

• Study Type: Interventional
• Enrollment (Actual): 355
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant; Other Names: pandemic; influenza; prevention; vaccine; influenza vaccine; influenza in humans
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; 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).; Other Names: Influenza; Pandemic vaccine; Seasonal vaccine; Co-vaccination; Prevention; Innfluenza vaccine; Influenza in humans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post vaccination HI antibody titer	21-28 days after vaccination
Incidence of adverse reactions	21-28 days after vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse reactions	50-60 days after vaccination

Collaborators and Investigators

• Sponsor: Fluart Innovative Vaccine Ltd, Hungary
• Investigators: Principal Investigator: Ferenc Tamás, MD, Pilisvörösvár District Doctor's Office; Study Director: Anna Ősi, Dr., Omninvest Ltd.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: November 7, 2009
• First Submitted That Met QC Criteria: November 7, 2009
• First Posted (Estimate): November 10, 2009

Study Record Updates

• Last Update Posted (Estimate): May 21, 2012
• Last Update Submitted That Met QC Criteria: May 18, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: vaccine; influenza; prevention; infection; pandemic; influenza vaccine; influenza in humans
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FLUVAL P-H-06