Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
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Purpose
Primary Objective:
To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
Secondary Objective:
To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Orthomyxoviruses Myxovirus Infection |
Biological: Influenza virus vaccine - cell based (2007-2008 Formulation) Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation) Biological: Influenza virus vaccine (2007-2008 Formulation) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Immunogenicity of Two Dosages of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine Administered in Healthy Adult Subjects Aged 18 to 49 Years |
- Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. [ Time Frame: Days 0 and 21 post-vaccination ] [ Designated as safety issue: No ]
- Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. [ Time Frame: Day 21 post-vaccination ] [ Designated as safety issue: No ]Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
- Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. [ Time Frame: Day 21 post-vaccination ] [ Designated as safety issue: No ]
Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21.
Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.
- Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]
Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.
Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.
| Enrollment: | 729 |
| Study Start Date: | October 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1: Standard-dose Cell-based Influenza Vaccine
Participants will receive a single dose of standard-dose cell-based influenza virus vaccine.
|
Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)
0.5 mL, Intramuscular
|
|
Experimental: Group 2: High-dose Cell-based Influenza Vaccine
Participants will receive a single dose of high-dose cell-based influenza virus vaccine.
|
Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)
1.0 mL, Intramuscular
|
|
Active Comparator: Group 3: Licensed Fluzone® Influenza Vaccine
Participants will receive a single dose of licensed Fluzone® influenza vaccine.
|
Biological: Influenza virus vaccine (2007-2008 Formulation)
0.5 mL, Intramuscular
Other Name: Fluzone® (2007-2008 formulation)
|
Detailed Description:
This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
- Healthy male or female subject, aged ≥ 18 to < 50 years on the day of inclusion
- Informed consent form signed
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman of childbearing potential: a negative urine pregnancy test and documented use of an effective method of contraception or abstinence for at least four weeks pre vaccination and up until three weeks post-vaccination
Exclusion Criteria :
- Subject currently breast-feeding.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Prior participation in the Phase I trial of FLU INTERPAN (PER.C6) vaccine (study GCE01).
- Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
- Systemic corticosteroid therapy as except the use of topical or inhalant corticosteroids
- Systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion (chronic illness may include, but is not limited to, cardiac, renal or auto-immune disorders, or diabetes).
- Receipt of blood or blood-derived products in the 3 months preceding vaccination.
- Receipt of any vaccination in the 4 weeks preceding vaccination, or planned receipt of any vaccination in the 4 weeks following the trial vaccination.
- History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months preceding vaccination.
- Previous vaccination against influenza (in the 6 months preceding the trial vaccination).
- Planned receipt of any other 2007-2008 influenza vaccine.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- History of Guillain-Barré syndrome
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Any other condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Contacts and Locations| United States, Alabama | |
| Hoover, Alabama, United States, 35216 | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Tucson, Arizona, United States, 85710 | |
| United States, Connecticut | |
| Milford, Connecticut, United States, 06460 | |
| United States, Florida | |
| Pinellas Park, Florida, United States, 33781 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60610 | |
| United States, Kansas | |
| Wichita, Kansas, United States, 67207 | |
| United States, Missouri | |
| Kansas City, Missouri, United States, 64114 | |
| Springfield, Missouri, United States, 65802 | |
| United States, North Carolina | |
| Cary, North Carolina, United States, 27518 | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45249 | |
| United States, Pennsylvania | |
| Bensalem, Pennsylvania, United States, 19020 | |
| United States, Rhode Island | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, South Carolina | |
| Mt Pleasant, South Carolina, United States, 29464 | |
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00845429 History of Changes |
| Other Study ID Numbers: | GCE03 |
| Study First Received: | February 13, 2009 |
| Results First Received: | November 17, 2012 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Influenza Orthomyxoviruses Split-virion inactivated influenza vaccine cell-based vaccine Adults |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013