Phase 4
N=120
Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00831987 ↗Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Aug 2009
Primary outcome: Primary: Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination — 60; 23; 8; 5 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fluzone®: Influenza virus vaccine 2004-2005 formulation (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Feb 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination |
60; 23; 8; 5; 0; 2 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine |
21.3; 15.6; 39.3; 19.8; 34.2; 25.6 | — |
| PRIMARY Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination |
60; 23; 87; 78; 45; 33 | — |
| PRIMARY Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination |
18; 5; 35; 33; 47; 23 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00831987). 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.