Status:
COMPLETED
Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004
Lead Sponsor:
Alachua Government Services, Inc.
Conditions:
Influenza
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.
Eligibility Criteria
Inclusion
- Male and female subjects will be eligible for participation in this study if they:
- are \>= 18 and \<= 60 years old (for Stratum A only);
- are \> 60 years old (for Stratum B only);
- are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial;
- 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 - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.
Exclusion
- Male and female subjects will be excluded from participation in this study if they:
- have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 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 immunological functions;
- have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
- have received a blood transfusion or immunoglobulins within one month of study entry;
- have a history of any vaccine-related contraindicating event (e.g. anaphylaxis);
- 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;
- had administration of an investigational drug within six weeks prior to the study start;
- are concurrently participating in a clinical trial;
- are pregnant or lactating.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00161837
Start Date
December 1 2003
End Date
July 1 2004
Last Update
October 9 2015
Active Locations (1)
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1
PANTAMED Sp.z o.o.
Olsztyn, Poland, PL-10-461