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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

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ClinicalTrials.gov Identifier: NCT00161837
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : October 9, 2015
Sponsor:
Information provided by:
Ology Bioservices

Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Biological: Vero Cell-derived Influenza Vaccine Biological: Egg-derived Influenza Vaccine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
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
Study Start Date : December 2003
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot





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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161837


Locations
Poland
PANTAMED Sp.z o.o.
Olsztyn, Poland, PL-10-461
Sponsors and Collaborators
Ology Bioservices
Investigators
Principal Investigator: Jerzy Romaszko, MD PANTAMED sp. z o o.

ClinicalTrials.gov Identifier: NCT00161837     History of Changes
Other Study ID Numbers: 227
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2006

Keywords provided by Ology Bioservices:
Influenza
Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs