Influenza Clinical Trial
Official title:
Annual Study of Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005
Verified date | April 2016 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To observe and to describe the safety during Days 0 to 21 following injection of the
2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in
subjects aged 18-59 years and subjects aged ≥ 60 years.
To measure and to describe the immune response (antibodies to hemagglutinin) 21 days
following injection of the 2004-2005 formulation of the inactivated, split-virion influenza
vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.
Status | Completed |
Enrollment | 120 |
Est. completion date | February 2006 |
Est. primary completion date | February 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria : - Participant aged 18 years or older. - Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study. - Participant is in reasonably good health as assessed by the investigator. - Participant willing and able to meet protocol requirements. - Participant 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) on 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. - Immunogenicity or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 3 months. - Receipt of blood or blood products within the 3 months preceding enrollment in the study. - Diabetes mellitus requiring pharmacological control. - Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine. - 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 Local and Systemic Reactions After Fluzone® Vaccination | Solicited local reactions: Erythema (redness), Induration, Bruising, and Pain at the injection site. Solicited systemic events: Fever (temperature), Chills, Rash, Headache, Cough, Runny nose, Nausea, Vomiting, Diarrhea, Malaise, Myalgia, and Arthralgia |
0 to 3 days post-vaccination | Yes |
Primary | Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine | GMTs and their 95% Confidence Intervals for each of the 3 antigens pre- and post-vaccination with Fluzone® 2004-2005 formulation. | Day 0 and Day 21 Post-Vaccination | No |
Primary | Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | 21 Days post-vaccination | Yes | |
Primary | Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination | Day 21 post-vaccination | No |
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