Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine in Adults and Elderly Persons

Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine (Trivalent, Seasonal, Active Ingredient Content: 15 μg HA/Strain/0.5 mL) in Adults and Elderly Persons

The purpose of this study is to determine the immunogenicity and tolerability of Fluval AB trivalent influenza vaccine in adults and elderly people.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Vaccination with Fluval AB influenza vaccine

Detailed Description

Immunogenicity Objective:

To assess immunogenicity of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.

Safety and Tolerability Objectives:

To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL).

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hungary
  • Veszprem, Hungary, H-8200
    • Fourmed Gyogyhaz Kft.
  • Pest
    • Pilisvorosvar, Pest, Hungary, H-2097
      • Family Doctor's Office

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 persons aged over 60 years, both sexes, mentally competent
• 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
• Female volunteers aged 18-60 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.
• Capability of participants to understand and comply with planned study procedures
• Participants aged above 18 years provide written informed consent prior to initiation of study procedures
• 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.
• Known hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine
• History of Guillain-Barré syndrome
• History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
• 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 derivate within the past 3 months
• Suspected or 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 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: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Influenza vaccination; Vaccination with a single dose of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each) and aluminium phosphate gel adjuvant.	Biological: Vaccination with Fluval AB influenza vaccine; Vaccination with a single dose of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each) and aluminium phosphate gel adjuvant.; Other Names: Influenza; Seasonal vaccine; Prevention; Influenza in humans; Vaccination; Influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post vaccination HI antibody titer	21-28 days following vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse reactions	21-28 days following vaccination

Collaborators and Investigators

• Sponsor: Fluart Innovative Vaccine Ltd, Hungary
• Investigators: Principal Investigator: Ferenc Tamás, MD, Family Doctor's Office Pilisvorosvar; Principal Investigator: László Sinka, MD, Fourmed Gyogyhaz Kft.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: July 26, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 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; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FluvalAB-H-YL2011; 2011-002158-30 (EudraCT Number)