Yearly Licence Tolerability and Immunogenicity Study of Fluval AB Seasonal Influenza Vaccine to be Used in the 2012/2013 Vaccination Season

NCT01649713 | Completed Phase 4

• 2 other identifiers: Fluval AB-H-YL20122012-002379-32
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

This is a yearly licence tolerability and immunogenicity study of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/strain/0.5mL) in adult and elderly subjects to assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection, as measured by haemagglutination inhibition (HI) test, and to evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.

Conditions

Influenza

Keywords

Fluval AB; influenza; vaccine; immunization; infections

Outcome Measures

Primary Outcomes (1)

• Assessment of immunogenicity measures in comparison to criteria specified in CPMP/BWP/214/96

  To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test in comparison to criteria specified in CPMP/BWP/214/96.

  21-28 days after immunization

Secondary Outcomes (1)

• To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular injection of Fluval AB suspension for injection.

  From Day 0 until 21-28 days after immunization

Study Arms (1)

Fluval AB vaccination

EXPERIMENTAL

In this uncontrolled, open, multi-centre immunogenicity and tolerability study subjects will be enrolled into one vaccination group and will be vaccinated by a single injection of Fluval AB suspension for injection.

Drug: Fluval AB vaccination

Interventions

Fluval AB vaccination DRUG

Vaccination with Fluval AB suspension for injection

Fluval AB vaccination

Eligibility Criteria

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

You may qualify if:

• Adult persons aged 18 to 59 years, elderly persons aged ≥60 years from 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 18-59 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 provide written informed consent prior to initiation of study procedures;

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.
• Known hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin, vancomycin 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 36 months prior to vaccination;
• Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
• Receipt of immunostimulants;
• Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within 3 months prior to vaccination;
• Suspected or known HIV, HBV or HCV infection;
• Acute disease and/or axillary temperature ≥37oC within 3 days prior to vaccination;
• Vaccine therapy within 4 weeks prior to vaccination;
• Influenza vaccination (any kind) within 6 months prior to vaccination;
• Experimental drug therapy within 4 weeks prior to vaccination;
• Concomitant participation in another clinical study;

Sponsors & Collaborators

• Fluart Innovative Vaccine Ltd, Hungary: lead

Study Sites (3)

District Doctor's Office

Budapest, H-1083, Hungary

Location

District Doctor's Office

Pilisvörösvar, H-2085, Hungary

Location

District Doctor's Office

Szentendre, H-2000, Hungary

Location

MeSH Terms

Conditions

Influenza, Human; Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Brigitta Kozma, MD

  Omninvest Ltd.

  STUDY DIRECTOR

• Ferenc Tamás, MD

  District Doctor's Office, Pilisvörösvar, Hungary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 25, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 12, 2012

Record last verified: 2012-10

Locations

HU (3)