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

Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine (Trivalent, Seasonal, Active Ingredient Content: 15 μg HA/Strain/0.5 mL) in Adults and Elderly Persons

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01404182

Enrollment

121

Registered

2011-07-27

Start date

2011-07-31

Completion date

2011-08-31

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

seasonal, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans

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.

Detailed description

Immunogenicity Objective: To assess immunogenicity of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test. Safety and Tolerability Objectives: To evaluate safety and tolerability (incidence of adverse events) of a single intramuscular (IM) injection of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL).

Interventions

BIOLOGICALVaccination with Fluval AB influenza vaccine

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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 * Absence of existence of any

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Post vaccination HI antibody titer	21-28 days following vaccination

Secondary

Measure	Time frame
Incidence of adverse reactions	21-28 days following vaccination

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026