A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2003 |
| End Date: | September 2003 |
Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004
To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation
of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and
subjects aged ≥ 60 years.
To describe the immune response at 21 days following injection of the 2003-2004 formulation
of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years
and subjects aged ≥ 60 years.
of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and
subjects aged ≥ 60 years.
To describe the immune response at 21 days following injection of the 2003-2004 formulation
of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years
and subjects aged ≥ 60 years.
Safety will be assessed throughout the trial period. Using antigens provided by Aventis
Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine
strains will be measured.
Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine
strains will be measured.
Inclusion Criteria :
- Age of 18 years or greater.
- Ambulatory.
- In reasonably good health as assessed by the investigator.
- Available for duration of the study (21 days + 2d).
- Willing and able to meet protocol requirements.
- Willing and able to give informed consent.
Exclusion Criteria :
- Self-reported allergy to egg proteins, chicken proteins, or one of the constituents
of the vaccine, such as thimerosal or formaldehyde.
- An acute illness with or without fever (temperature >100.4°F) in the 72 hours
preceding enrollment in the trial.
- Clinically significant findings in vital signs (including temperature >100.4°F) or
review of systems.
- Self-reported history of severe adverse event to any influenza vaccine.
- Vaccination against influenza in the 6 months preceding enrollment in the study.
- Any vaccination in the 14 days preceding enrollment in the study or scheduled between
Visit 1 and Visit 3.
- Participation in any other experimental drug or vaccine trial within the 30 days
preceding enrollment into the study.
- Immunosuppressive therapy including long-term (> 2 weeks) systemic corticosteroids or
cancer therapy within the past 3 months or ongoing.
- Receipt of blood or blood products within the 3 months preceding enrollment in the
study.
- Diabetes
- Any condition which, in the opinion of the investigator, would pose a health risk to
the subject or interfere with the evaluation of the vaccine (e.g., existing severe
chronic illness such as pulmonary disorders, cardiovascular disorders, chronic blood
disorders, etc.).
- Person deprived of freedom by an administrative or court order (having legal or
medical guardian).
- For women of childbearing age, a positive urine pregnancy test, breast feeding, or
not using a medically approved and reliable form of contraception (oral
contraceptives or double barrier method) for the duration of the trial.
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