Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00845429|
Recruitment Status : Completed
First Posted : February 18, 2009
Results First Posted : December 17, 2012
Last Update Posted : December 19, 2012
To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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)
- 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.
- 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.
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
|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.|