Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived)

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00289510
First received: February 9, 2006
Last updated: October 16, 2007
Last verified: October 2007
  Purpose

The objective of this study is to assess the safety and immunogenicity of inactivated influenza vaccine (whole virion, Vero cell derived). Subjects will be randomly assigned to receive a single injection of whole virion, Vero cell derived or egg derived influenza vaccine on Day 0. Subjects will return to the study site for safety evaluation at predetermined intervals for 180 days after vaccination. Subjects will also have blood drawn at predetermined intervals to measure their immunologic response to vaccination.


Condition Intervention Phase
Influenza
Biological: Inactivated influenza vaccine (whole virion, Vero cell-derived)
Biological: Inactivated influenza vaccine (egg derived) [licensed control vaccine]
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Single-Blind, Randomized, Controlled Phase I/II Study to Compare the Safety and Immunogenicity of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) With a License Egg Derived Influenza Vaccine

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment: 423
Study Start Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Male and female subjects who

  • are 18 to 45 years of age, inclusive, on the day of screening;
  • have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry;
  • 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);
  • agree to keep a daily record of symptoms;
  • if female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Subjects who

  • have received any influenza vaccination for the 2005/2006 influenza season and/or the 2004/2005 influenza season;
  • have received any vaccination within 2 weeks prior to vaccination in this study;
  • 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) that can be expected to influence immune response;
  • 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, allergy to eggs, allergy to components of the test or comparator vaccine, other known contraindications);
  • have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating;
  • have a known or suspected problem with alcohol or drug abuse;
  • are unable to lead an independent life as a result of either physical or mental handicap;
  • were administered an investigational drug within six weeks prior to study entry;
  • are concurrently participating in a clinical study that includes the administration of an investigational product;
  • if female, are pregnant or lactating;
  • are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289510

Locations
Austria
Allgemeines Krankenhaus Wien (General Hospital Vienna)
Vienna, Austria, 1090
Germany
Klinikum Westend, Haus 18
Berlin, Germany, 14050
Internistische Gemeinschaftspraxis Dr. Regner & Dr. Schmitt (Group practice for internal medicine)
Mainz, Germany, 55116
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Markus Müller, MD Allgemeines Krankenhaus Wien (General Hospital Vienna)
Principal Investigator: Kasra Shakeri-Nejad, MD Klinikum Westend, Berlin
Principal Investigator: Bernhard Schmitt, MD Internistische Gemeinschaftspraxis (Group practice for internal medicine) Dr. Regner & Dr. Schmitt, Mainz
Principal Investigator: Alen Jambrecina, MD MDS Pharma Services Germany GmbH, Hamburg
Principal Investigator: Stephan De la Motte, MD Harrison Clinical Research / Clinical Unit, Munich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00289510     History of Changes
Other Study ID Numbers: 710501
Study First Received: February 9, 2006
Last Updated: October 16, 2007
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Federal Ministry for Health and Women

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 August 28, 2014