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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
ClinicalTrials.gov Identifier:
NCT01404182
First received: July 26, 2011
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Influenza
Biological: Vaccination with Fluval AB influenza vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Omninvest Vaccine Manufacturing, Researching and Trading Ltd.:

Primary Outcome Measures:
  • Post vaccination HI antibody titer [ Time Frame: 21-28 days following vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse reactions [ Time Frame: 21-28 days following vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 121
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Vaccination
  • Prevention
  • Influenza vaccine
  • Influenza in humans

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404182

Locations
Hungary
Family Doctor's Office
Pilisvorosvar, Pest, Hungary, H-2097
Fourmed Gyogyhaz Kft.
Veszprem, Hungary, H-8200
Sponsors and Collaborators
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
Investigators
Principal Investigator: Ferenc Tamás, MD Family Doctor's Office Pilisvorosvar
Principal Investigator: László Sinka, MD Fourmed Gyogyhaz Kft.
  More Information

No publications provided

Responsible Party: Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
ClinicalTrials.gov Identifier: NCT01404182     History of Changes
Other Study ID Numbers: FluvalAB-H-YL2011, 2011-002158-30
Study First Received: July 26, 2011
Last Updated: May 18, 2012
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Omninvest Vaccine Manufacturing, Researching and Trading Ltd.:
seasonal
prevention
influenza
infection
influenza vaccine
vaccine
influenza in humans

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014