Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine

Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00778297

Enrollment

234

Registered

2008-10-23

Start date

2007-11-30

Completion date

2008-05-31

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

prevention, influenza, infection, vaccine, Influenza vaccine, Influenza in humans

Brief summary

This is a single blind, reference drug controlled, one center viral immunogenicity and tolerability study of FluvalAB FL-K-004 Trivalent Influenza Vaccine with 6 μg HA/strain/dos antigen content to assess immunogenicity and tolerability. The aim of the study is to assess the immunogenicity and tolerability of FluvalAB FL-K-004 trivalent influenza vaccine with 6 μg HA/strain/dos antigen content (study drug) in age groups 18-60 years and over 60 years, with the objective to verify efficacy and tolerability of the study drug according to CPMP/BWP/214/96: Note for Guidance on Harmonization of Requirements for Influenza Vaccines, 12 March 1997.

Interventions

BIOLOGICALVaccination with FluvalAB FL-K-004 trivalent flu vaccine

Treatment: 6 μg HA/strain/dos of FluvalAB FL-K-004 trivalent influenza vaccine will be administered once (at Day 0).

BIOLOGICALVaccination with FluvalAB trivalent influenza vaccine

Treatment: 15 μg HA/strain/dos of FluvalAB trivalent influenza vaccine will be administered once (at Day 0).

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

* Adult volunteers in good health aged over 18 years, both sexes; * Full contractual capacity of the participants; * Are in good health (as determined by vital signs and medical history); * Negative urine or serum pregnancy test for females of childbearing potential; * Are able to understand and comply with planned study procedures; * Signed 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 titre	21-28 days after vaccination
Incidence of adverse reactions	21-28 days after vaccination

Secondary

Measure	Time frame
Post-vaccination HI antibody titer	110-120 days after vaccination

Countries

Hungary

Outcome results

None listed

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