Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Able to understand and give informed consent
- * Participants of child bearing potential must agree to use effective birth control for the duration of the study. A negative urine pregnancy test must be documented prior to vaccination.
- * History of allergy or serious adverse reaction, including Guillain-Barré syndrome, to a vaccine or vaccine products
- * History of a medical condition resulting in impaired immunity such as active solid tumors, leukemia, lymphoma, chemotherapy or radiation therapy, autoimmune conditions, or splenic dysfunction. Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
- * History of asthma, cochlear implant, or active cerebrospinal fluid leak
- * Use of immune modifying drugs including: systemic steroids for more than 1 week (such as prednisone \> 20mg/day), chronic administration (more than 14 days total) of immunosuppressive or immunomodulatory drugs in the prior 3 months
- * History of HIV, Hepatitis B or Hepatitis C infection
- * Chronic clinically significant medical problems that could be considered active or unstable (i.e diagnosed within the past 3 months or requiring a change in medication within the past 3 months). This is including (but not limited to):
- * Insulin dependent diabetes
- * Severe heart disease (including arrhythmias)
- * Severe lung disease
- * Severe liver disease
- * Severe kidney disease
- * Severe hypertension: defined as life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit).
- * Congenital genetic syndromes (e.g., trisomy 21)
- * Body Mass Index (BMI) \> 35
- * Pregnancy or breast feeding, or plans to become pregnant in the next month
- * History of influenza infection or vaccination within the current or previous influenza season
- * Receipt of blood products or immune globulin product within the prior 3 months
- * History of excessive alcohol consumption, drug use, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the trial
- * Receipt of any live vaccines 30 days before, or plans to receive any live vaccines 30 days after vaccination
- * Receipt of any inactivated vaccines 14 days before, or plans to receive any inactivated vaccines 14 days after vaccination
- * Receipt of any non-registered or other investigational product in 30 days before, or plans to receive any other investigational product 30 days after vaccination
- * Temporary
Ages Eligible for Study
18 Years to 49 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
Yes