Phase 4
N=120
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00743275 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcome: Primary: Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine. — 35; 18; 34; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Split, Inactivated, Trivalent Influenza vaccine (Fluzone®) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine. |
35; 18; 34; 16; 0; 1 | — |
| PRIMARY Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation |
26.9; 16.9; 34.9; 31.5; 28.5; 21.6 | — |
| PRIMARY Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection) |
88; 63; 98; 98; 82; 67 | — |
| PRIMARY Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion) |
42; 33; 77; 84; 36; 31 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00743275). 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.