Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine in Adults and Elderly Persons

NCT01404182 | Completed Phase 4

• 2 other identifiers: FluvalAB-H-YL20112011-002158-30
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the immunogenicity and tolerability of Fluval AB trivalent influenza vaccine in adults and elderly people.

Conditions

Influenza

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Post vaccination HI antibody titer

  21-28 days following vaccination

Secondary Outcomes (1)

• Incidence of adverse reactions

  21-28 days following vaccination

Study Arms (1)

Influenza vaccination

EXPERIMENTAL

Vaccination with a single dose of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each) and aluminium phosphate gel adjuvant.

Biological: Vaccination with Fluval AB influenza vaccine

Interventions

Vaccination with Fluval AB influenza vaccine BIOLOGICAL

Vaccination with a single dose of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each) and aluminium phosphate gel adjuvant.

Also known as: Influenza, Seasonal vaccine, Vaccination, Prevention, Influenza vaccine, Influenza in humans

Influenza vaccination

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 to 60 years, elderly persons aged over 60 years, 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 18-60 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.
• Capability of participants to understand and comply with planned study procedures
• Participants aged above 18 years 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 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 the past 36 months
• Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids
• Receipt of immunostimulants,
• Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within the past 3 months
• Suspected or 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 (2)

Family Doctor's Office

Pilisvörösvár, Pest County, H-2097, Hungary

Location

Fourmed Gyogyhaz Kft.

Veszprém, Veszprém megye, H-8200, Hungary

Location

MeSH Terms

Conditions

Influenza, Human; Infections

Interventions

Vaccination; Influenza Vaccines

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; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ferenc Tamás, MD

  Family Doctor's Office Pilisvorosvar

  PRINCIPAL INVESTIGATOR

• László Sinka, MD

  Fourmed Gyogyhaz Kft.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 21, 2012

Record last verified: 2012-05

Locations

HU (2)