Safety and Immunogenicity Study of Fluval AB-Like Flu Vaccines With 3.5, 6, 9 or 15 μg HA in Adult and Elderly People

NCT ID: NCT01408290

Last Updated: 2012-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-10-31

Brief Summary

The purpose of this study is to determine the immunogenicity, tolerability and dose-effect relationship of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.

Detailed Description

Primary immunogenicity objectives

• To assess immunogenicity of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by haemagglutination inhibition (HI) test 21 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96.
• To determine dose-effect relationship between one 0.5 mL IM injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens and immune response provoked 21 days after vaccination in terms of pre- and postimmunization HA titers as measured by HI test.

Secondary immunogenicity objectives

• To assess immunogenicity of one 0.5 mL IM injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by HI test 14 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of post-immunization HA titers as measured by HI test 21 days after vaccination.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of post-immunization HA titers as measured by HI test 14 days after vaccination.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of the percentage of subjects achieving seroconversion or significant increase in antibody titer at day 21 after vaccination.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of the percentage of subjects achieving seroconversion or significant increase in antibody titer at day 14 after vaccination.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of Day 21/Day 0 geometric mean titer ratios (GMTRs) as determined by HI.
• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of Day 14/Day 0 geometric mean titer ratios (GMTRs) as determined by HI.

Safety and tolerability objective

• To evaluate the safety of the administration of one 0.5 mL IM injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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 (32 subjects aged 18-60 years /Group 2A/ and 32 subjects aged over 60 years /Group 2E/).

Group Type: EXPERIMENTAL

Vaccination with FAB-6011

Intervention Type: BIOLOGICAL

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

FAB-9011

\- One 0.5 mL injection of FAB-9011 trivalent influenza vaccine containing 9μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens (32 subjects aged 18-60 years /Group 3A/ and 32 subjects aged over 60 years/Group 3E/).

Group Type: EXPERIMENTAL

Vaccination with FAB-9011

Intervention Type: BIOLOGICAL

One 0.5 mL injection of FAB-9011 trivalent influenza vaccine containing 9μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

FLUVALAB

\- One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens (32 subjects aged 18-60 years /Group 4A/ and 32 subjects aged over 60 years/Group 4E/).

Group Type: EXPERIMENTAL

Vaccination with FluvalAB

Intervention Type: BIOLOGICAL

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

FAB-3511

\- One 0.5 mL injection of FAB-3511 trivalent influenza vaccine containing 3.5μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens (32 subjects aged 18-60 years /Group 1A/ and 32 subjects aged over 60 years /Group 1E/).

Group Type: EXPERIMENTAL

Vaccination with FAB-3511

Intervention Type: BIOLOGICAL

One 0.5 mL injection of FAB-3511 trivalent influenza vaccine containing 3.5μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

Interventions

Vaccination with FAB-3511

One 0.5 mL injection of FAB-3511 trivalent influenza vaccine containing 3.5μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Vaccination with FAB-9011

One 0.5 mL injection of FAB-9011 trivalent influenza vaccine containing 9μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

FAB-3511; FAB-6011; FAB-9011; FluvalAB

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fluart Innovative Vaccine Ltd, Hungary

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabor Kollar, MD

Role: STUDY_DIRECTOR

Omninvest Ltd

József Fűzi, MD

Role: PRINCIPAL_INVESTIGATOR

Family Doctor's Office, Dunakeszi

Ágnes Hasitz, MD

Role: PRINCIPAL_INVESTIGATOR

Family Doctor's Office, Szentendre

Judit Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Family Doctor's Office, Budapest

Péter Torzsa, MD

Role: PRINCIPAL_INVESTIGATOR

Family Doctor's Office, Budapest

Locations

Family Doctor's Office

Dunakeszi, Pest County, Hungary

Family Doctor's Office

Szentendre, Pest County, Hungary

Family Doctor's Office

Budapest, , Hungary

Family Doctor's Office

Budapest, , Hungary

Countries

Hungary

Other Identifiers

2011-003166-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FluvalAB-H-14

Identifier Type: -

Identifier Source: org_study_id