NCT00778297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

2 months

First QC Date

October 22, 2008

Last Update Submit

May 18, 2012

Conditions

Influenza

Keywords

preventioninfluenzainfectionvaccineInfluenza vaccineInfluenza in humans

Outcome Measures

Primary Outcomes (2)

  • Post-vaccination HI antibody titre

    21-28 days after vaccination

  • Incidence of adverse reactions

    21-28 days after vaccination

Secondary Outcomes (1)

  • Post-vaccination HI antibody titer

    110-120 days after vaccination

Study Arms (2)

Group 1

EXPERIMENTAL
Biological: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine

Group 2

ACTIVE COMPARATOR
Biological: Vaccination with FluvalAB trivalent influenza vaccine

Interventions

Vaccination with FluvalAB FL-K-004 trivalent flu vaccineBIOLOGICAL

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

Group 1
Vaccination with FluvalAB trivalent influenza vaccineBIOLOGICAL

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

Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Known allergy to eggs or other components of the vaccine;
  • History of Guillain-Barré syndrome;
  • Pregnancy or breast feeding or positive pregnancy test prior to vaccination;
  • Immunosuppressive therapy in the preceding 36 months;
  • Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
  • Concomitant corticosteroid therapy, including inhaled corticosteroids;
  • Psychiatric illness and/or concomitant psychiatric drug therapy;
  • Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
  • Vaccine therapy within 4 weeks prior to the study;
  • Influenza vaccination within 6 months prior to the study;
  • Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immune response;
  • Documented HIV, HBV or HCV infection;
  • Acute febrile respiratory illness within one week prior to vaccination;
  • Experimental drug therapy within 1 month prior to vaccination;
  • Alcohol or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pilisvörösvár District Doctor's Office

Pilisvörösvár, 2085, Hungary

Location

MeSH Terms

Conditions

Influenza, HumanInfections

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Officials

  • Ferenc Tamás, MD

    Pilisvörösvár District Doctor's Office

    PRINCIPAL INVESTIGATOR

  • Zsuzsa Galambos, MD

    Omninvest Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

November 1, 2007

Primary Completion

January 1, 2008

Study Completion

May 1, 2008

Last Updated

May 21, 2012

Record last verified: 2012-05

Locations

HU(1)