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

NCT ID: NCT00161811

Last Updated: 2015-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2005-07-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Vero Cell-derived Influenza Vaccine

Intervention Type: BIOLOGICAL

Egg cell-derived Influenza Vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alachua Government Services, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Markus Müller, MD

Role: PRINCIPAL_INVESTIGATOR

Vienna General Hospital (AKH), Department of Clinical Pharmacology

Pirmin Habermehl, MD

Role: PRINCIPAL_INVESTIGATOR

Mainz University Children´s Clinic, Center for Clinical Studies

Locations

Vienna General Hospital (AKH), Department of Clinical Pharmacology

Vienna, Vienna, Austria

Neuendorfstr. 20

Henningsdorf, , Germany

Münstererstr. 1a

Mainz, , Germany

Mainz University Children´s Clinic

Mainz, , Germany

Countries

Austria; Germany

Other Identifiers

EudraCT Number: 2004-001374-34

Identifier Type: -

Identifier Source: secondary_id

231

Identifier Type: -

Identifier Source: org_study_id