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

October 7, 2015 updated by: Ology Bioservices

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Vienna General Hospital (AKH), Department of Clinical Pharmacology
  • Germany
      • Henningsdorf, Germany, 16761
        • Neuendorfstr. 20
      • Mainz, Germany, 55116
        • Münstererstr. 1a
      • Mainz, Germany, D-55101
        • Mainz University Children´s Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ology Bioservices

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 231
  • EudraCT Number: 2004-001374-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe