Evaluating the Safety and Immunogenicity of a Live Attenuated Virus Vaccine to Prevent Influenza H3N2v Disease

This is an interventional prevention trial for Influenza focused on measuring H3N2v Influenza Viruses Read More

Inclusion Criteria:

• Males and non-pregnant females between 6 and 26 years of age inclusive.
• For children, presence of an adult caregiver who is in good health and able to understand and carry out the requirements
• General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
• Agree to storage of blood specimens for future research.
• Available for the duration of the trial.
• Willingness to participate in the study as evidenced by signing the informed consent document. Verbal assent will be obtained from minors 6 to 12 years of age and signed assent will be obtained from minors 13 and older.
• Female subjects of childbearing potential must agree to use effective birth control methods for the duration of the study (e.g., pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse, surgical sterilization).

Exclusion Criteria:

• Anticipated direct routine [e.g. weekly or more frequent] contact with individuals younger than the designated age groups being studied as a result of household contact, occupation, or participation in day care with such individuals.
• Pregnancy as determined by a positive urine or serum human choriogonadotropin (β-HCG) test.
• Currently breast-feeding.
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history or physical examination.
• Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, affects the ability of the subject to understand and cooperate with the study protocol.
• Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
• History of anaphylaxis.
• Allergy to oseltamivir as determined by subject report.
• Current diagnosis of asthma or reactive airway disease (within the past 2 years).
• Use of aspirin or salicylate-containing medications within 28 days prior to randomization or expected receipt through 28 days after final vaccination.
• History of Guillain-Barré Syndrome.
• Known history of HIV, hepatitis C, or active hepatitis B infection.
• Known immunodeficiency syndrome.
• Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination.
• Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination.
• Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination.
• Travel to the Southern Hemisphere within 14 days prior to study vaccination.
• Travel on a cruise ship within 14 days prior to study vaccination.
• Receipt of another investigational vaccine or drug within 30 days prior to study vaccination.
• Allergy to eggs or egg products, gentamicin, or gelatin.
• Chronic use of intranasal medications.