Clinical Trial: Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process with a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004

This study has been completed.

Sponsored by: Baxter BioScience
Information provided by: Baxter BioScience
ClinicalTrials.gov Identifier: NCT00161837

Purpose

The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.
Condition Intervention Phase
Influenza
 Vaccine: Vero Cell-derived Influenza Vaccine
 Vaccine: Egg-derived Influenza Vaccine
Phase II
Phase III

MedlinePlus related topics:  Flu

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment

Official Title: Single-Blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) in Comparison to a Licensed Egg-Derived Influenza Vaccine for Season 2003/2004

Further Study Details: 

Study start: December 2003;  Study completion: July 2004

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

  • are >= 18 and <= 60 years old (for Stratum A only);
  • are > 60 years old (for Stratum B only);
  • are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial;
  • will reliably keep a daily record of symptoms;
  • understand the nature of the study, agree to its provisions, and give written informed consent;
  • if female and capable of bearing children – show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Male and female subjects will be excluded from participation in this study if they:

  • have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 season;
  • suffer from any kind of immunodeficiency;
  • suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions;
  • have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
  • have received a blood transfusion or immunoglobulins within one month of study entry;
  • have a history of any vaccine-related contraindicating event (e.g. anaphylaxis);
  • have a rash or dermatological condition which may interfere with injection site reaction rating;
  • have a known or suspected problem with drug or alcohol abuse;
  • are unable to lead an independent life either physically or mentally;
  • had administration of an investigational drug within six weeks prior to the study start;
  • are concurrently participating in a clinical trial;
  • are pregnant or lactating.

Location Information


Poland
      PANTAMED Sp.z o.o., Olsztyn,  PL-10-461,  Poland

Study chairs or principal investigators

Baxter BioScience Investigator,  Principal Investigator,  Baxter BioScience   

More Information

Study ID Numbers:  227
Last Updated:  September 12, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00161837
Health Authority: Poland: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13

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