Vaccine Safety: Data-Sharing Process |
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Clinical Trial: 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
This study has been completed.
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Influenza | Vaccine: Vero Cell-derived Influenza Vaccine Vaccine: Egg-derived Influenza Vaccine | Phase II Phase III |
MedlinePlus related topics: Flu
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title: Single-Blind Randomized Controlled Phase II/III Study to Investigate the Immunogenicity and Safety of an Inactivated Influenza Vaccine (Whole Virion, Vero Cell Derived) in Comparison to a Licensed Egg-Derived Influenza Vaccine for Season 2003/2004
Study start: December 2003; Study completion: July 2004
Eligibility
Accepts Healthy Volunteers
Inclusion Criteria:
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 Criteria:
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.
Location Information
Poland
PANTAMED Sp.z o.o., Olsztyn, PL-10-461, Poland
Baxter BioScience Investigator, Principal Investigator, Baxter BioScience
More Information
Last Updated: September 12, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00161837
Health Authority: Poland: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13

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