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Yearly Strain Variation Study, 2009/2010

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00943657
First received: July 21, 2009
Last updated: October 6, 2009
Last verified: October 2009
History of Changes
  Purpose

The purpose of this study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to World Heath Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly licensing application.


Condition Intervention Phase
Influenza
Seasonal Influenza
 Biological: Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-Label Phase 3 Study to Assess the Immunogenicity and Safety of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult and Elderly Population

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Number of subjects demonstrating seroconversion to each of the three antigens contained in the vaccine 21 days after vaccination [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]
    Single intramuscular injection of vaccine
    Other Name: Preflucel
  Eligibility

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

Inclusion Criteria:

  • Subject is 18 to 59 years of age , inclusive, at the time of screening (for subjects in age stratum A only)
  • Subject is 60 years of age or older , inclusive, at the time of screening (for subjects in age stratum B only)
  • Subject has given written informed consent prior to study entry
  • Subject is generally healthy , as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
  • Subject agrees to keep a daily record of symptoms for the duration of the study
  • If female of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
  • Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

  • Subject has a history of severe allergic reaction or anaphylaxis
  • Subject has an oral temperature of >= 37.5°C on the day of vaccination in this study
  • Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating
  • Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
  • Subject has received a seasonal influenza vaccine within 6 months of study entry
  • Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
  • Subject has any inherited or acquired immunodeficiency
  • Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
  • Subject has a functional or surgical asplenia
  • Subject has a known or suspected problem with alcohol or drug abuse
  • Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
  • If female, subject is pregnant or lactating at the time of study enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943657

Locations
Austria
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Gerald Aichinger, MD; Study Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00943657     History of Changes
Other Study ID Numbers: 720901
Study First Received: July 21, 2009
Last Updated: October 6, 2009
Health Authority: Austria: Federal Ministry for Health Family and Youth

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 June 18, 2013