Back to results

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

Primary Purpose

Influenza

Status

Completed

Phase

Not Applicable

Locations

Hungary

Study Type

Interventional

Intervention

Vaccination with FAB-6011

Vaccination with FluvalAB

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:

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.

Sites / Locations

Péter Vajer
Barna Bőze
Family Doctor's Office
Tibor Hrutka
Family Doctor's Office
Family Doctor's Office
Family Doctor's Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FAB-6011

FLUVALAB

Arm Description

One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens

One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens

Outcomes

Primary Outcome Measures

Measures of immunogenicity

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

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

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

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.

Full Information

NCT ID

NCT01459276

First Posted

October 19, 2011

Last Updated

May 18, 2012

Sponsor

Fluart Innovative Vaccine Ltd, Hungary

1. Study Identification

Unique Protocol Identification Number

NCT01459276

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fluart Innovative Vaccine Ltd, Hungary

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1206 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FAB-6011

Arm Type

Experimental

Arm Description

One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens

Arm Title

FLUVALAB

Arm Type

Active Comparator

Arm Description

One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μg HA of seasonal A/H1N1, A/H3N2 and B influenza antigens

Intervention Type

Biological

Intervention Name(s)

Vaccination with FAB-6011

Other Intervention Name(s)

FAB-6011

Intervention Description

One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

Intervention Type

Biological

Intervention Name(s)

Vaccination with FluvalAB

Other Intervention Name(s)

FluvalAB

Intervention Description

One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

Primary Outcome Measure Information:

Title

Measures of immunogenicity

Description

Time Frame

21-28 days following vaccination

Title

Measures of safety

Description

Time Frame

21-28 days following vaccination

Secondary Outcome Measure Information:

Title

Measures of long term immunogenicity

Description

Time Frame

110-120 days following vaccination

Title

Measures of long term safety

Description

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.

Time Frame

110-120 days following vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: