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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014