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

NCT01459276 | Completed

• 2 other identifiers: FluvalAB-H-152011-003314-16
• Study Type: interventional
• Target: 1,206
• Locations: 1 country
• Sites: 7

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.

Conditions

Influenza

Keywords

seasonal; prevention; influenza; infection; influenza vaccine; vaccine; influenza in humans

Outcome Measures

Primary Outcomes (2)

• 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.

  21-28 days following vaccination

• 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.

  21-28 days following vaccination

Secondary Outcomes (2)

• Measures of long term immunogenicity

  110-120 days following vaccination

• Measures of long term safety

  110-120 days following vaccination

Study Arms (2)

FAB-6011

EXPERIMENTAL

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

FLUVALAB

ACTIVE COMPARATOR

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

Interventions

Vaccination with FAB-6011 BIOLOGICAL

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

Also known as: FAB-6011

FAB-6011

Vaccination with FluvalAB BIOLOGICAL

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

Also known as: FluvalAB

FLUVALAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fluart Innovative Vaccine Ltd, Hungary: lead

Study Sites (7)

Péter Vajer

Biatorbágy, Pest County, 2051, Hungary

Location

Barna Bőze

Hatvan, Pest County, 3000, Hungary

Location

Family Doctor's Office

Szentendre, Pest County, 2000, Hungary

Location

Tibor Hrutka

Vecsés, Pest County, 2220, Hungary

Location

Family Doctor's Office

Budapest, 1083, Hungary

Location

Family Doctor's Office

Budapest, 1136, Hungary

Location

Family Doctor's Office

Pilisvörösvár, 2085, Hungary

Location

MeSH Terms

Conditions

Influenza, Human; Infections

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Gabor Kollar, MD

  Omninvest Ltd

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: October 25, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: May 21, 2012

Record last verified: 2012-05

Locations

HU (7)