Safety and Immunogenicity Study of Fluval AB-Like Flu Vaccines With 3.5, 6, 9 or 15 μg HA in Adult and Elderly People

A Randomized, Double Blind, Multicentre Study to Evaluate Safety and Immunogenicity of Four Fluval AB-Like Influenza Vaccines With 3.5 μgHA, 6 μgHA, 9 μgHA Or 15 μgHA Of A/H1N1, A/H3N2 and B Influenza Antigens in Adult and Elderly Subjects

The purpose of this study is to determine the immunogenicity, tolerability and dose-effect relationship of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA 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 FAB-9011; Biological: Vaccination with FluvalAB; Biological: Vaccination with FAB-3511

Detailed Description

Primary immunogenicity objectives

• To assess immunogenicity of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by haemagglutination inhibition (HI) test 21 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96.
• To determine dose-effect relationship between one 0.5 mL IM injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens and immune response provoked 21 days after vaccination in terms of pre- and postimmunization HA titers as measured by HI test.

Secondary immunogenicity objectives

• To assess immunogenicity of one 0.5 mL IM injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by HI test 14 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of post-immunization HA titers as measured by HI test 21 days after vaccination.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of post-immunization HA titers as measured by HI test 14 days after vaccination.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of the percentage of subjects achieving seroconversion or significant increase in antibody titer at day 21 after vaccination.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of the percentage of subjects achieving seroconversion or significant increase in antibody titer at day 14 after vaccination.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of Day 21/Day 0 geometric mean titer ratios (GMTRs) as determined by HI.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of Day 14/Day 0 geometric mean titer ratios (GMTRs) as determined by HI.

Safety and tolerability objective

• To evaluate the safety of the administration of one 0.5 mL IM injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1083
    • Family Doctor's Office
  • Budapest, Hungary, 1136
    • Family Doctor's Office
  • Pest
    • Dunakeszi, Pest, Hungary, 2120
      • Family Doctor's Office
    • Szentendre, Pest, Hungary, 2000
      • Family Doctor's Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 (32 subjects aged 18-60 years /Group 2A/ and 32 subjects aged over 60 years /Group 2E/).	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
Experimental: FAB-9011; - One 0.5 mL injection of FAB-9011 trivalent influenza vaccine containing 9μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens (32 subjects aged 18-60 years /Group 3A/ and 32 subjects aged over 60 years/Group 3E/).	Biological: Vaccination with FAB-9011; One 0.5 mL injection of FAB-9011 trivalent influenza vaccine containing 9μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.; Other Names: FAB-9011
Experimental: FLUVALAB; - One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens (32 subjects aged 18-60 years /Group 4A/ and 32 subjects aged over 60 years/Group 4E/).	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
Experimental: FAB-3511; - One 0.5 mL injection of FAB-3511 trivalent influenza vaccine containing 3.5μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens (32 subjects aged 18-60 years /Group 1A/ and 32 subjects aged over 60 years /Group 1E/).	Biological: Vaccination with FAB-3511; One 0.5 mL injection of FAB-3511 trivalent influenza vaccine containing 3.5μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.; Other Names: FAB-3511

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEASURES OF IMMUNOGENICITY	The measures of immunogenicity, for all evaluable subjects by using HI test are: the GMTs at Day 0, at Day 14 and at Day 21 as determined by HI;; the Day 14/Day 0, the Day 21/Day 0 and the Day 21/Day 14 geometric mean titer ratios (GMTRs) as determined by HI;; the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2 at Day 14 an at Day 21, as determined by HI;; the percentage of subjects achieving a titer ≥40 at Day 0, at Day 14 and at Day 21 as determined by HI.	21-28 days following vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEASURES OF SAFETY	Number and percentage of subjects with at least one local reaction between Day 0 and Day 7 after vaccination.; Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 7 after vaccination.; Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit at Day 21.	21-28 days following vaccination

Collaborators and Investigators

• Sponsor: Fluart Innovative Vaccine Ltd, Hungary
• Investigators: Study Director: Gabor Kollar, MD, Omninvest Ltd; Principal Investigator: József Fűzi, MD, Family Doctor's Office, Dunakeszi; 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

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: August 1, 2011
• First Submitted That Met QC Criteria: August 1, 2011
• First Posted (Estimate): August 3, 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-14; 2011-003166-32 (EudraCT Number)