Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine

Tolerability and Immunogenicity Study of FLUVAL P Monovalent Influenza Vaccine in Adults and Elderly Persons

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01010893

Enrollment

355

Registered

2009-11-10

Start date

2009-08-31

Completion date

2010-02-28

Last updated

2012-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

pandemic, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans

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.

Interventions

BIOLOGICALVaccination 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).

BIOLOGICALVaccination 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Post vaccination HI antibody titer	21-28 days after vaccination
Incidence of adverse reactions	21-28 days after vaccination

Secondary

Measure	Time frame
Incidence of adverse reactions	50-60 days after vaccination

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026