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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

November 7, 2009
May 18, 2012
August 2009
September 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01010893 on ClinicalTrials.gov Archive Site
Incidence of adverse reactions [ Time Frame: 50-60 days after vaccination ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine
Tolerability and Immunogenicity Study of FLUVAL P Monovalent Influenza Vaccine in Adults and Elderly Persons

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Influenza
  • 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
  • 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
    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).
    Intervention: Biological: Vaccination with Fluval P monovalent influenza vaccine
  • 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).
    Intervention: Biological: Vaccination with Fluval P and Fluval AB influenza vaccines
Vajo Z, Tamas F, Sinka L, Jankovics I. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet. 2010 Jan 2;375(9708):49-55. doi: 10.1016/S0140-6736(09)62039-0. Epub 2009 Dec 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
355
February 2010
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Hungary
 
NCT01010893
FLUVAL P-H-06
Yes
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
Not Provided
Principal Investigator: Ferenc Tamas, MD Pilisvorosvar District Doctor's Office
Study Director: Anna Osi, Dr. Omninvest Ltd.
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP