Status:
COMPLETED
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
Lead Sponsor:
Alachua Government Services, Inc.
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 va...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT00161811
Start Date
November 1 2004
End Date
July 1 2005
Last Update
October 9 2015
Active Locations (4)
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1
Vienna General Hospital (AKH), Department of Clinical Pharmacology
Vienna, Vienna, Austria, 1090
2
Neuendorfstr. 20
Henningsdorf, Germany, 16761
3
Münstererstr. 1a
Mainz, Germany, 55116
4
Mainz University Children´s Clinic
Mainz, Germany, D-55101