Clinical trial NCT01010893: Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine
Official title: Tolerability and Immunogenicity Study of FLUVAL P Monovalent Influenza Vaccine in Adults and Elderly Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: pandemic
prevention
influenza
infection
influenza vaccine
vaccine
influenza in humans
Lead sponsor: Fluart Innovative Vaccine Ltd, Hungary
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Post vaccination HI antibody titer
timeFrame: 21-28 days after vaccination
measure: Incidence of adverse reactions
timeFrame: 21-28 days after vaccination
Secondary outcomes:
measure: Incidence of adverse reactions
timeFrame: 50-60 days after vaccination
Other outcomes:
Locations:
city: Pilisvorosvar
country: Hungary
facility: District Doctor's Office
city: Veszprem
country: Hungary
facility: Fourmed Kft. Gyogyhaz
Study officials:
affiliation: Pilisvorosvar District Doctor's Office
name: Ferenc Tamas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Omninvest Ltd.
name: Anna Osi, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.