Influenza
Conditions
Keywords
Influenza, Influenza Vaccine
Brief summary
To submit remaining available sera to Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.
Interventions
BIOLOGICALInfluenza Virus Vaccine (2006-2007 Fluzone® vaccine)
Influenza vaccine
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant aged 18 years or older on the day of inclusion. * 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. * 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 (temperature ≥ 99.5 °F oral) in the 72 hours preceding enrollment in the trial. * Clinically significant findings in vital signs (including temperature ≥ 99.5 °F oral) on 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 3. * Vaccination planned in the 4 weeks following Fluzone® vaccination at Visit 1. * Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study. * Immunocompromising 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 form of contraception for the duration of the trial. * Current abuse of alcohol or drug addiction 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | 0-3 days post-vaccination | Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation) |
| Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | 21 days post-vaccination | GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from October through December 2006 in 1 medical clinic in the US
Pre-assignment details
A total of 116 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Aged 18 to 59 Years Participants aged 18 to 59 years at enrollment | 60 |
| Aged ≥ 60 Years Participants aged 60 years and older at enrollment | 56 |
| Total | 116 |
Baseline characteristics
| Characteristic | Aged ≥ 60 Years | Aged 18 to 59 Years | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 47 Participants | 0 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 60 Participants | 69 Participants |
| Age, Continuous | 76.4 years STANDARD_DEVIATION 8.55 | 39.5 years STANDARD_DEVIATION 12.25 | 57.3 years STANDARD_DEVIATION 21.33 |
| Region of Enrollment United States | 56 participants | 60 participants | 116 participants |
| Sex: Female, Male Female | 37 Participants | 49 Participants | 86 Participants |
| Sex: Female, Male Male | 19 Participants | 11 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 60 | 2 / 56 |
| serious Total, serious adverse events | 0 / 60 | 0 / 56 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination
GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.
Time frame: 21 days post-vaccination
Population: Geometric Mean Titers were evaluated in the per-protocol immunogenicity Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Aged 18 to 59 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | B FLU B/MALAYSIA SPLIT/2506/2004 - PRE | 117 Titer |
| Aged 18 to 59 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | H1N1 FLU A/NEW CALEDONIA/20/99 - POST | 214 Titer |
| Aged 18 to 59 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | B FLU B/MALAYSIA SPLIT/2506/2004 - POST | 788 Titer |
| Aged 18 to 59 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | H3N2 FLU A/WISCONSIN/67/2005 - PRE | 67.9 Titer |
| Aged 18 to 59 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | H1N1 FLU A/NEW CALEDONIA/20/99 - PRE | 66.2 Titer |
| Aged 18 to 59 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | H3N2 FLU A/WISCONSIN/67/2005 - POST | 453 Titer |
| Aged ≥ 60 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | B FLU B/MALAYSIA SPLIT/2506/2004 - POST | 597 Titer |
| Aged ≥ 60 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | H3N2 FLU A/WISCONSIN/67/2005 - POST | 513 Titer |
| Aged ≥ 60 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | B FLU B/MALAYSIA SPLIT/2506/2004 - PRE | 195 Titer |
| Aged ≥ 60 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | H1N1 FLU A/NEW CALEDONIA/20/99 - PRE | 36.9 Titer |
| Aged ≥ 60 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | H1N1 FLU A/NEW CALEDONIA/20/99 - POST | 77.0 Titer |
| Aged ≥ 60 Years | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination | H3N2 FLU A/WISCONSIN/67/2005 - PRE | 110 Titer |
Primary
Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination
Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)
Time frame: 0-3 days post-vaccination
Population: Analysis was on all enrolled and vaccinated participants, Intend-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Solicited Injection Site Reaction | 78 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Swelling | 3 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Fever | 3 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Redness | 7 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Fever (> 102.2°F) | 0 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Malaise | 25 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Headache | 39 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Pain (Incapacitating) | 0 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Headache (Prevented daily activities) | 2 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Malaise (Prevented daily activities) | 2 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Solicited Systemic Reaction | 49 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Myalgia | 27 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Pain | 78 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Myalgia (Prevented daily activities) | 2 Percentage of Participants |
| Aged 18 to 59 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Redness (≥ 5.0 cm) | 0 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Myalgia (Prevented daily activities) | 0 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Pain (Incapacitating) | 0 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Redness | 9 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Solicited Systemic Reaction | 29 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Fever | 2 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Malaise | 9 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Solicited Injection Site Reaction | 38 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Redness (≥ 5.0 cm) | 4 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Swelling | 6 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Swelling (≥ 5.0 cm) | 0 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Fever (> 102.2°F) | 0 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Headache | 11 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Headache (Prevented daily activities) | 0 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Grade 3 Malaise (Prevented daily activities) | 0 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Myalgia | 21 Percentage of Participants |
| Aged ≥ 60 Years | Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination | Any Pain | 30 Percentage of Participants |