Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
ClinicalTrials.gov Identifier:
NCT01010893
First received: November 7, 2009
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug.


Condition Intervention
Influenza
Biological: Vaccination with Fluval P and Fluval AB influenza vaccines
Biological: Vaccination with Fluval P monovalent influenza vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Tolerability and Immunogenicity Study of FLUVAL P Monovalent Influenza Vaccine in Adults and Elderly Persons

Resource links provided by NLM:


Further study details as provided by Omninvest Vaccine Manufacturing, Researching and Trading Ltd.:

Primary Outcome Measures:
  • Post vaccination HI antibody titer [ Time Frame: 21-28 days after vaccination ] [ Designated as safety issue: No ]
  • Incidence of adverse reactions [ Time Frame: 21-28 days after vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of adverse reactions [ Time Frame: 50-60 days after vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 355
Study Start Date: August 2009
Study Completion Date: February 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccination
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose).
Biological: Vaccination with Fluval P monovalent influenza vaccine
Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant
Other Names:
  • pandemic
  • influenza
  • prevention
  • vaccine
  • influenza vaccine
  • influenza in humans
Experimental: Influenza vaccination and co-vaccination
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).
Biological: Vaccination with Fluval P and Fluval AB influenza vaccines
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).
Other Names:
  • Influenza
  • Pandemic vaccine
  • Seasonal vaccine
  • Co-vaccination
  • Prevention
  • Innfluenza vaccine
  • Influenza in humans

Detailed Description:

Primary Objective:

To assess tolerability/safety (incidence of adverse events) of the study drug. To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21‑28 after immunization in groups and age groups.

Secondary Objectives:

To assess the long-term safety of the study drug 50-60 days after immunization. To determine the tolerability of simultaneous administration of FLUVAL P monovalent pandemic influenza vaccine and FLUVAL AB trivalent seasonal influenza vaccine in case of adults and elderly people.

To assess the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season.

To assess the immunogenicity of the study drug by optional cross-reactive immunity tests performed with non-homologous influenza A and B virus strains.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults aged 18 to 60 years, elderly people aged over 60 years, from both sexes, with full contractual capacity;
  • 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;
  • Femal volunteers 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.
  • Capable of understanding and complying with study protocol requirements;
  • The volunteers provide written informed consent prior to initiation of study procedures;
  • Absence of existence of any exclusion criteria.

Exclusion Criteria:

  • Pregnancy or breast feeding or positive urine pregnancy test at baseline prior to vaccination;
  • Known allergy to eggs or other components of the vaccine (in particular mercury);
  • History of Guillain-Barré syndrome;
  • Active neoplasm;
  • Immunosuppressive therapy in the preceding 36 months;
  • Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
  • Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
  • Documented HIV, HBV or HCV infection;
  • Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immunoresponse;
  • Acute febrile respiratory illness within one week prior to vaccination;
  • Vaccine therapy within 4 weeks prior to vaccination;
  • Influenza vaccination within 6 months prior to vaccination;
  • Experimental drug therapy within 1 month prior to vaccination;
  • Past or current psychiatric disease of the volunteer that upon judgement of the investigator may have effect on the objective decision-making of the volunteer;
  • Alcohol or drug abuse of the participant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010893

Locations
Hungary
District Doctor's Office
Pilisvorosvar, Hungary, H-2085
Fourmed Kft. Gyogyhaz
Veszprem, Hungary, H-8200
Sponsors and Collaborators
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
Investigators
Principal Investigator: Ferenc Tamas, MD Pilisvorosvar District Doctor's Office
Study Director: Anna Osi, Dr. Omninvest Ltd.
  More Information

No publications provided by Omninvest Vaccine Manufacturing, Researching and Trading Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
ClinicalTrials.gov Identifier: NCT01010893     History of Changes
Other Study ID Numbers: FLUVAL P-H-06
Study First Received: November 7, 2009
Last Updated: May 18, 2012
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Omninvest Vaccine Manufacturing, Researching and Trading Ltd.:
pandemic
prevention
influenza
infection
influenza vaccine
vaccine
influenza in humans

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Aluminum phosphate
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014