Phase 4
N=121
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00835926 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Oct 2009
Primary outcome: Primary: Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® — 15; 7; 0; 2 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Influenza virus vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Sep 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® |
15; 7; 0; 2; 20; 12 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® |
29.6; 20.4; 67.1; 37.5; 18.3; 9.5 | — |
| PRIMARY Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® |
28; 18; 30; 8; 38; 22 | — |
| PRIMARY Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® |
74; 60; 62; 25; 41; 25 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00835926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.