Influenza Clinical Trial
Official title:
A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults Greater Than or Equal to 18 to Less Than 65 Years of Age
The purpose of this study is to investigate the effectiveness, safety, and tolerability of an influenza vaccine. Influenza is a highly infectious disease that occurs throughout the world in the winter months. Infection with an influenza virus is a major public health threat as it has the ability to spread rapidly and affect large numbers of people. Up to 1359 healthy adults ages 18 to less than 65 years old will participate in this study for up to 24 days. Volunteers will receive an injection of either influenza vaccine with thimerosal, vaccine without thimerosal, or placebo with thimerosal. Volunteers will be asked to document information about any health changes for 21 days following vaccination. Volunteers will return to the clinic on days 5 and 21 after vaccination to share this information with study staff. On day 21, volunteers will have a physical examination. Blood samples will be taken prior to vaccination and at Day 21 post-vaccination.
Status | Completed |
Enrollment | 1359 |
Est. completion date | August 2006 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Is a healthy male or nonpregnant female (as indicated by a negative urine or serum pregnancy test immediately prior to vaccine administration) aged greater than or equal to 18 years to less than 65 years at the time of informed consent. - Provides written informed consent to participate in the study and adherence to all protocol requirements. - Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history. - Is able to understand and comply with planned study procedures. - Is female of nonchildbearing potential, ie, either surgically sterilized or 1 year postmenopausal. If female is of child bearing potential, she must be abstinent or using adequate contraceptive precautions, eg, intrauterine device, oral contraceptive, or equivalent hormonal contraception (eg, progestogen-only implant, cutaneous hormonal patch, injectable contraceptives, or diaphragm) and agree to continue such precautions for 2 months after vaccination. Exclusion Criteria: - Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken feathers, neomycin, polymyxin, thimerosal, or any components of the study vaccines. - Has been vaccinated against influenza in the previous 6 months. - Has underlying medical condition for which influenza vaccination is recommended; chronic heart or lung condition including asthma; metabolic disease; kidney disease; blood disorder (such as sickle cell anemia); or weakened immune system including HIV/AIDS. - Has acute clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality. - Has known history of Guillain-Barré Syndrome. - Has clinical signs of active infection and/or an oral temperature of greater than or equal to 38°C (100.4°F). Study entry may be deferred for such individuals at the discretion of the Principal Investigator (PI). - Has history of neurological disorders or seizures, with exception of a single febrile seizure during childhood. - Has confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed immunodeficiency disorder (congenital or acquired). - Currently receiving (within the 90 days before receiving the study vaccines) immunosuppressive or immunomodulative therapy, systemic corticosteroids, and including the following medications: - Chronic or long-term corticosteroids: greater than 15mg/day of oral prednisolone or equivalent daily; - Sporadic corticosteroids: greater than 40mg/day of oral prednisolone or equivalent for more than 2 courses of greater than 14 days in the 3 months preceding vaccination; - Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. Note: Use of topical or inhalant corticosteroids prior to administration of the study vaccines or throughout the study is acceptable. - Participated in a clinical trial or use of an investigational compound within 30 days before receiving the study vaccine or plans to enter a study during the study period. - Was vaccinated with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the study vaccine. - Currently treated with cytotoxic drugs or at any time during the 6 months before administration of the study vaccines. - Has major congenital defects or serious chronic illness. - Has evidence or history of (within the previous 12 months) drug or alcohol abuse. - Is unwilling or unable to comply with the study protocol. - Has a history of psychiatric disorders that, in the opinion of the PI, would prevent the subject from giving proper informed consent or otherwise interfere with the study. - Is a resident of nursing home or long-term care facility. - Has any condition that, in the opinion of the PI, would prevent the subject from complying with all aspects of the protocol or will put the subject at unnecessary risk. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Clinical Alliance for Research & Education - Infectious Diseases | Annandale | Virginia |
United States | University of Maryland Baltimore | Baltimore | Maryland |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Baylor College of Medicine | Houston | Texas |
United States | University of Iowa | Iowa City | Iowa |
United States | Vanderbilt University | Nashville | Tennessee |
United States | University of Rochester | Rochester | New York |
United States | Saint Louis University | St. Louis | Missouri |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Talbot HK, Keitel W, Cate TR, Treanor J, Campbell J, Brady RC, Graham I, Dekker CL, Ho D, Winokur P, Walter E, Bennet J, Formica N, Hartel G, Skeljo M, Edwards KM. Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine. Vaccine. 2008 Jul 29;26(32):4057-61. doi: 10.1016/j.vaccine.2008.05.024. Epub 2008 Jun 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunogenicity endpoints of seroprotection rate and seroconversion rate will be assessed. | Day 0 prior to vaccination and day 21 after vaccination. | No | |
Secondary | Comparison of the geometric mean titers to influenza hemagglutinin antigens after vaccination of the active treatment arms. | Day 0 prior to vaccination and day 21 after vaccination. | No | |
Secondary | The number and rate of the type, frequency and intensity of adverse events in the active treatment arms. | Solicited adverse events through day 4 (days 0, 1, 2, 3, 4) following vaccination; unsolicited adverse events to day 21 after vaccination. | Yes |
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