Influenza Clinical Trial
Official title:
Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)
Verified date | January 2014 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009
formulation.
To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion
influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human
Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
Status | Completed |
Enrollment | 120 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Participant is 18 years of age or older on the day of inclusion. - Participant willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study. - Participant in reasonably good health as assessed by the Investigator. - Participant willing and able to give informed consent. - For a woman, inability to bear a child or negative serum/urine pregnancy test. 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 in the 72 hours preceding enrollment in the trial. - Clinically significant findings in vital signs (including temperature = 99.5°F oral) or review of systems. - Self-reported history of severe adverse event to any influenza vaccine. - Laboratory-confirmed influenza infection or 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 2. - Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.* - Immunocompromising condition 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 6 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 potential, 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. - Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures. - Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. - Prior personal history of Guillain-Barré syndrome. * Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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 | Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine. | Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering | Days 0-3 post-vaccination | Yes |
Primary | Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation | Day 0 and 21 days post-vaccination | No | |
Primary | Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection) | Seroprotection was defined as post-vaccination titer value of = 1:40. | 21 days post-vaccination | No |
Primary | Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion) | Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation | 21 days post-vaccination | No |
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