Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
Study Group
Participants received one dose of Fluzone® vaccine on Day 0.
Intervention: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®) (Biological)
Outcomes
Primary Outcomes
Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion)
Time Frame: 21 days post-vaccination
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
Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation
Time Frame: Day 0 and 21 days post-vaccination
Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Time Frame: Days 0-3 post-vaccination
Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering
Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection)
Time Frame: 21 days post-vaccination
Seroprotection was defined as post-vaccination titer value of ≥ 1:40.
Secondary Outcomes
No secondary outcomes reported