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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Vaccination with Fluval AB influenza vaccine
Sponsored by
Fluart Innovative Vaccine Ltd, Hungary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring seasonal, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Family Doctor's Office
  • Fourmed Gyogyhaz Kft.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Influenza vaccination

Arm Description

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.

Outcomes

Primary Outcome Measures

Post vaccination HI antibody titer

Secondary Outcome Measures

Incidence of adverse reactions

Full Information

First Posted
July 26, 2011
Last Updated
May 18, 2012
Sponsor
Fluart Innovative Vaccine Ltd, Hungary
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1. Study Identification

Unique Protocol Identification Number
NCT01404182
Brief Title
Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine in Adults and Elderly Persons
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fluart Innovative Vaccine Ltd, Hungary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
seasonal, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Influenza vaccination
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Vaccination with Fluval AB influenza vaccine
Other Intervention Name(s)
Influenza, Seasonal vaccine, Vaccination, Prevention, Influenza vaccine, Influenza in humans
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post vaccination HI antibody titer
Time Frame
21-28 days following vaccination
Secondary Outcome Measure Information:
Title
Incidence of adverse reactions
Time Frame
21-28 days following vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferenc Tamás, MD
Organizational Affiliation
Family Doctor's Office Pilisvorosvar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
László Sinka, MD
Organizational Affiliation
Fourmed Gyogyhaz Kft.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Doctor's Office
City
Pilisvorosvar
State/Province
Pest
ZIP/Postal Code
H-2097
Country
Hungary
Facility Name
Fourmed Gyogyhaz Kft.
City
Veszprem
ZIP/Postal Code
H-8200
Country
Hungary

12. IPD Sharing Statement

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

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