A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects

A Randomized, Active Controlled, Double-blind, Multi-Centre Study to Evaluate Safety and Immunogenicity of One Dose of FLUVAL AB-like (Trivalent, Whole Virus, Aluminium Phosphate Gel Adjuvanted) Influenza Vaccine Containing 6μgHA of Seasonal A/H1N1, A/H3N2 and B Influenza Antigens in Non-elderly Adult and Elderly Subjects

The purpose of this study is to determine the immunogenicity and tolerability of one 0.5 mL intramuscular (IM) injection of FLUVAL AB-like trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Vaccination with FAB-6011; Biological: Vaccination with FluvalAB

• Study Type: Interventional
• Enrollment (Actual): 1206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1083
    • Family Doctor's Office
  • Budapest, Hungary, 1136
    • Family Doctor's Office
  • Pilisvörösvár, Hungary, 2085
    • Family Doctor's Office
  • Pest
    • Biatorbágy, Pest, Hungary, 2051
      • Péter Vajer
    • Hatvan, Pest, Hungary, 3000
      • Barna Bőze
    • Szentendre, Pest, Hungary, 2000
      • Family Doctor's Office
    • Vecsés, Pest, Hungary, 2220
      • Tibor Hrutka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male and female adult volunteers aged 18 years or older,
• mentally competent,
• able to understand and comply with all study requirements,
• willing and able to give written informed consent prior to initiation of study procedures,
• in good health (as determined by clinical judgement of the investigator on the basis of medical history 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.
• Female subjects aged 18 to 60 years (i.e. participants 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.
• Absence of existence of any exclusion criteria.

Exclusion Criteria:

• Pregnancy, breast-feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
• Hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine;
• History of anaphylactic shock or neurological symptoms or signs following administration of any vaccine;
• History of Guillain-Barré syndrome;
• Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure;
• Immunosuppressive therapy within the past 36 months;
• Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
• Receipt of immunostimulants;
• Receipt of parenteral immunoglobulin, blood products and/or plasma derivates within the past 3 months;
• Suspected or known HIV, HBV or HCV infection;
• Acute disease and/or axillary temperature ≥37oC within the past 3 days;
• Vaccine therapy within the past 4 weeks;
• Influenza vaccination (any kind) within the past 6 months;
• Experimental drug therapy within the past 4 weeks;
• Concomitant participation in another clinical study;
• Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study;
• Past or current psychiatric disease of the subject that upon judgement of the investigator may have effect on the objective decision-making of the subject;
• Alcohol or drug abuse of the subject.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAB-6011; One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens	Biological: Vaccination with FAB-6011; One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.; Other Names: FAB-6011
Active Comparator: FLUVALAB; One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens	Biological: Vaccination with FluvalAB; One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.; Other Names: FluvalAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measures of immunogenicity	The measures of immunogenicity (by using HI test) are: the GMTs at Day 0 and at Day 21; the Day 21/Day 0 geometric mean titer ratios (GMTRs); the percentage of subjects achieving seroconversion or significant increase in antibody titer at Day 21; the percentage of subjects achieving a titer ≥40 at Day 0 and at Day 21.	21-28 days following vaccination
Measures of safety	The measures of safety are: Number and percentage of subjects with at least; one local reaction between Day 0 and Day 7; one systemic reaction between Day 0 and Day 7; one adverse event between Day 0 and visit at Day 21.	21-28 days following vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measures of long term immunogenicity	The measures of long term immunogenicity (by using HI test) are: the GMTs at Day 0 and at Day 120; the Day 120/Day 0 geometric mean titer ratios (GMTRs); the percentage of subjects achieving seroconversion or significant increase in antibody titer at Day 120; the percentage of subjects achieving a titer ≥40 at Day 0 and at Day 120.	110-120 days following vaccination
Measures of long term safety	The measures of long term safety are: Number and percentage of subjects with at least; one local reaction; one systemic reaction; one adverse event between Day 0 and visit at Day 120.	110-120 days following vaccination

Collaborators and Investigators

• Sponsor: Fluart Innovative Vaccine Ltd, Hungary
• Investigators: Study Director: Gabor Kollar, MD, Omninvest Ltd; Principal Investigator: Ágnes Hasitz, MD, Family Doctor's Office, Szentendre; Principal Investigator: Judit Simon, MD, Family Doctor's Office, Budapest; Principal Investigator: Péter Torzsa, MD, Family Doctor's Office, Budapest; Principal Investigator: Ferenc Tamás, MD, Family Doctor's Office, Pilisvörösvár; Principal Investigator: Barna Bőze, MD, Family Doctor's Office, Hatvan; Principal Investigator: Tibor Hrutka, MD, Family Doctor's Office, Vecsés; Principal Investigator: Péter Vajer, MD, Family Doctor's Office, Biatorbágy

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 21, 2011
• First Posted (Estimate): October 25, 2011

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; influenza vaccine; seasonal; influenza in humans
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: FluvalAB-H-15; 2011-003314-16 (EudraCT Number)