Status:
COMPLETED
Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
The purpose of this Phase III, randomized, double-blinded, placebo-controlled, multi-center study is to evaluate the immunogenicity, safety, and tolerability of CSL Limited Inactivated Influenza Vacci...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
1359 Patients enrolled
Trial Details
Trial ID
NCT00333398
Start Date
June 1 2006
End Date
August 1 2006
Last Update
August 27 2010
Active Locations (10)
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1
Stanford University
Stanford, California, United States, 94305-5208
2
University of Iowa
Iowa City, Iowa, United States, 52242
3
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
4
Saint Louis University
St Louis, Missouri, United States, 63131