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Comparison of the Safety and Immune Response of Three Different Lots of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2004/2005

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00161811
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : October 9, 2015
Information provided by:
Ology Bioservices

Brief Summary:
The objectives of the study are to assess the immunogenicity and safety among three different lots 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 cell-derived Influenza Vaccine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Single-blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety After a Single Vaccination With Three Different Lots of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell-derived) in Comparison to a Licensed Egg Derived Influenza Vaccine for Season 2004/2005.
Study Start Date : November 2004
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

  • are >= 18 and <= 60 years old on the day of screening (for Stratum A only);
  • are > 60 years old on the day of screening (for Stratum B only);
  • are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study);
  • 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 - have a negative pregnancy test (urine) result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Subjects will be excluded from participation in this study if they:

  • have received any influenza vaccine for the 2003/2004 season and/or for the 2004/2005 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 the normal immunologic functions;
  • have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
  • have received a blood transfusion or immunoglobulins within 30 days of study entry;
  • have donated blood or plasma within 30 days of study entry;
  • have a history of any vaccine-related contraindicating event (e.g. anaphylaxis or other known contraindications);
  • 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;
  • were administered an investigational drug within six weeks prior to study entry;
  • are concurrently participating in a clinical study including the administration of an investigational product;
  • if female, 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 identifier (NCT number): NCT00161811

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Vienna General Hospital (AKH), Department of Clinical Pharmacology
Vienna, Austria, 1090
Neuendorfstr. 20
Henningsdorf, Germany, 16761
Münstererstr. 1a
Mainz, Germany, 55116
Mainz University Children´s Clinic
Mainz, Germany, D-55101
Sponsors and Collaborators
Ology Bioservices
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Principal Investigator: Markus Müller, MD Vienna General Hospital (AKH), Department of Clinical Pharmacology
Principal Investigator: Pirmin Habermehl, MD Mainz University Children´s Clinic, Center for Clinical Studies
Layout table for additonal information Identifier: NCT00161811    
Other Study ID Numbers: 231
EudraCT Number: 2004-001374-34
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2006
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs