Trial record 1 of 1 for:
GCE03
Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
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| ClinicalTrials.gov Identifier: NCT00845429 |
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Recruitment Status :
Completed
First Posted : February 18, 2009
Results First Posted : December 17, 2012
Last Update Posted : December 19, 2012
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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Brief Summary:
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 or disease | Intervention/treatment | 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 (Clinical Trial) |
| Actual Enrollment : | 729 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (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 |
| Study Start Date : | October 2007 |
| Actual Primary Completion Date : | August 2008 |
| Actual Study Completion Date : | November 2008 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Influenza Vaccines
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1: Standard-dose Cell-based Influenza Vaccine
Participants will receive a single dose of standard-dose cell-based influenza virus vaccine.
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Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)
0.5 mL, Intramuscular |
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Experimental: Group 2: High-dose Cell-based Influenza Vaccine
Participants will receive a single dose of high-dose cell-based influenza virus vaccine.
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Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)
1.0 mL, Intramuscular |
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Active Comparator: Group 3: Licensed Fluzone® Influenza Vaccine
Participants will receive a single dose of licensed Fluzone® influenza vaccine.
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Biological: Influenza virus vaccine (2007-2008 Formulation)
0.5 mL, Intramuscular
Other Name: Fluzone® (2007-2008 formulation) |
Primary Outcome Measures :
- 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 ]
- Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. [ Time Frame: Day 21 post-vaccination ]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 ]
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.
Secondary Outcome Measures :
- 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 ]
Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.
Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.
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| Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845429
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 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
Additional Information:
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00845429 |
| Other Study ID Numbers: |
GCE03 |
| First Posted: | February 18, 2009 Key Record Dates |
| Results First Posted: | December 17, 2012 |
| Last Update Posted: | December 19, 2012 |
| Last Verified: | December 2012 |
Keywords provided by Sanofi:
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Influenza Orthomyxoviruses Split-virion inactivated influenza vaccine cell-based vaccine Adults |
Additional relevant MeSH terms:
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Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |