Influenza Clinical Trial
Official title:
Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Cell-Derived Trivalent Subunit Influenza Vaccine in Subjects Aged >= 18 Years and <= 64 Years During Two Consecutive Years.
Verified date | September 2013 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination
Status | Completed |
Enrollment | 1270 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria 1. Willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. Men and women aged >= 18 and <= 64 years. 3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator. Exclusion Criteria 1. Known to be allergic to constituents of the vaccine. 2. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator. 3. Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Site Reference ID/Investigator# 45683 | Austin | Texas |
United States | Site Reference ID/Investigator# 45695 | Fort Worth | Texas |
United States | Site Reference ID/Investigator# 45690 | Jacksonville | Florida |
United States | Site Reference ID/Investigator# 45684 | Kansas City | Missouri |
United States | Site Reference ID/Investigator# 45686 | Las Vegas | Nevada |
United States | Site Reference ID/Investigator# 45691 | Lenexa | Kansas |
United States | Site Reference ID/Investigator# 45682 | Lexington | Kentucky |
United States | Site Reference ID/Investigator# 45696 | Nashville | Tennessee |
United States | Site Reference ID/Investigator# 45685 | Omaha | Nebraska |
United States | Site Reference ID/Investigator# 45689 | Overland Park | Kansas |
United States | Site Reference ID/Investigator# 45687 | Pembroke Pines | Florida |
United States | Site Reference ID/Investigator# 45688 | Raleigh | North Carolina |
United States | Site Reference ID/Investigator# 45692 | Salt Lake City | Utah |
United States | Site Reference ID/Investigator# 45697 | South Miami | Florida |
United States | Site Reference ID/Investigator# 45694 | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Abbott Biologicals | Quintiles, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines. | 3 weeks | No | |
Primary | To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo. | 6 months | Yes | |
Secondary | To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine. | 6 months | No | |
Secondary | To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination. | 3 weeks | No | |
Secondary | To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine. | 6 months | Yes |
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