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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
ClinicalTrials.gov Identifier:
NCT00778297
First received: October 22, 2008
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Influenza
Biological: Vaccination with FluvalAB FL-K-004 trivalent flu vaccine
Biological: Vaccination with FluvalAB trivalent influenza vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine With 6 Mcg HA/Strain/Dos Antigen Content

Resource links provided by NLM:


Further study details as provided by Omninvest Vaccine Manufacturing, Researching and Trading Ltd.:

Primary Outcome Measures:
  • Post-vaccination HI antibody titre [ Time Frame: 21-28 days after vaccination ] [ Designated as safety issue: No ]
  • Incidence of adverse reactions [ Time Frame: 21-28 days after vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post-vaccination HI antibody titer [ Time Frame: 110-120 days after vaccination ] [ Designated as safety issue: No ]

Enrollment: 234
Study Start Date: November 2007
Study Completion Date: May 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Biological: Vaccination 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).
Active Comparator: Group 2 Biological: Vaccination with FluvalAB trivalent influenza vaccine
Treatment: 15 μg HA/strain/dos of FluvalAB trivalent influenza vaccine will be administered once (at Day 0).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778297

Locations
Hungary
Pilisvörösvár District Doctor's Office
Pilisvörösvár, Hungary, 2085
Sponsors and Collaborators
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
Investigators
Principal Investigator: Ferenc Tamás, MD Pilisvörösvár District Doctor's Office
Study Director: Zsuzsa Galambos, MD Omninvest Ltd.
  More Information

No publications provided

Responsible Party: Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
ClinicalTrials.gov Identifier: NCT00778297     History of Changes
Other Study ID Numbers: FluvalAB-H-05, OGYI 28438/82/07, EudraCT 2007-004239-52
Study First Received: October 22, 2008
Last Updated: May 18, 2012
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Omninvest Vaccine Manufacturing, Researching and Trading Ltd.:
prevention
influenza
infection
vaccine
Influenza vaccine
Influenza in humans

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014