Influenza Clinical Trial
Official title:
Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004
Verified date | April 2016 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 121 |
Est. completion date | September 2003 |
Est. primary completion date | September 2003 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® | Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site. Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia |
Days 0 to 3 Post-vaccination | Yes |
Primary | Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay. | Day 0 and Day 21 Post-vaccination | No |
Primary | Percentage of Participants With a = 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay. | Day 21 Post-vaccination | No |
Primary | Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers = 40 Post-Vaccination With Fluzone® | Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay | Day 21 Post-vaccination | No |
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