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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
ClinicalTrials.gov Identifier:
NCT01459276
First received: October 19, 2011
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Influenza
Biological: Vaccination with FAB-6011
Biological: Vaccination with FluvalAB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Measures of immunogenicity [ Time Frame: 21-28 days following vaccination ] [ Designated as safety issue: No ]

    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.

  • Measures of safety [ Time Frame: 21-28 days following vaccination ] [ Designated as safety issue: Yes ]

    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.


Secondary Outcome Measures:
  • Measures of long term immunogenicity [ Time Frame: 110-120 days following vaccination ] [ Designated as safety issue: No ]

    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.

  • Measures of long term safety [ Time Frame: 110-120 days following vaccination ] [ Designated as safety issue: Yes ]

    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.


Enrollment: 1206
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: FluvalAB

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01459276

Locations
Hungary
Péter Vajer
Biatorbágy, Pest, Hungary, 2051
Barna Bőze
Hatvan, Pest, Hungary, 3000
Family Doctor's Office
Szentendre, Pest, Hungary, 2000
Tibor Hrutka
Vecsés, Pest, Hungary, 2220
Family Doctor's Office
Budapest, Hungary, 1136
Family Doctor's Office
Budapest, Hungary, 1083
Family Doctor's Office
Pilisvörösvár, Hungary, 2085
Sponsors and Collaborators
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
Investigators
Study Director: Gabor Kollar, MD Omninvest Ltd
Principal Investigator: Ferenc Tamás, MD Family Doctor's Office, Pilisvörösvár
Principal Investigator: Ágnes Hasitz, MD Family Doctor's Office, Szentendre
Principal Investigator: Judit Simon, MD Family Doctor's Office, Budapest
Principal Investigator: Barna Bőze, MD Family Doctor's Office, Hatvan
Principal Investigator: Tibor Hrutka, MD Family Doctor's Office, Vecsés
Principal Investigator: Péter Torzsa, MD Family Doctor's Office, Budapest
Principal Investigator: Péter Vajer, MD Family Doctor's Office, Biatorbágy
  More Information

No publications provided

Responsible Party: Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
ClinicalTrials.gov Identifier: NCT01459276     History of Changes
Other Study ID Numbers: FluvalAB-H-15, 2011-003314-16
Study First Received: October 19, 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 August 28, 2014