Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedImmune LLC
Age
18–49
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Males or females, 18 to 49 years of age (not yet reached their 50th birthday) at the time of study vaccination
Healthy by medical history and health assessment
Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral, implanted, injectable, or transdermal contraceptives, intrauterine device \[IUD\], female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for at least 30 days prior to study vaccination, and must agree to continue using such precautions for at least 90 days after study vaccination; the volunteer must also have a negative serum or urine pregnancy test within 14 days prior to study vaccination (if screening and study vaccination do not occur on the same day) and on the day of study vaccination prior to randomization
Sexually active males, unless surgically sterile, must use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions for at least 30 days after study vaccination
Available by telephone
Written informed consent (and Health Insurance Portability and Accountability Act \[HIPAA\] authorization if applicable) obtained from the participant
Ability to understand and comply with the requirements of the protocol, as judged by the investigator
Ability to complete follow-up period of 180 days after study vaccination, as required by the protocol
You may not be if
History of hypersensitivity of any component of the vaccine, including egg or egg protein
History of hypersensitivity to gentamicin
Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (e.g., asthma); chronic metabolic diseases (e.g., diabetes mellitus); renal dysfunction; or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year.
Acute febrile (\>100.0°F oral or equivalent) and/or clinically significant respiratory illness (e.g., cough or sore throat) within the 14 days prior to randomization
Any known immunosuppressive condition or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy
History of Guillain-Barré syndrome
Household contact who is immunocompromised (participant should also avoid close contact with immunocompromised individuals for at least 21 days post study vaccination)
Receipt of any investigational agent within 30 days prior to enrollment, or expected receipt through 180 days after study vaccination (use of licensed agents for indications not listed in the package insert is permitted)
Chronic or regular use of anti-pyretic or analgesic medication on a daily or every other day basis.
Note: A daily dose of 81 mg of aspirin is not considered a contraindication to enrollment. Discontinuation of prophylactic use of anti-pyretic or analgesic medications at the time of enrollment and for 14 days following vaccination is not considered a contraindication to enrollment.
Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after study vaccination
Nursing mother
Employee of the research center, any individual involved with the conduct of the study, or any family member of such individuals
Any condition that, in the opinion of the investigator, would interfere with evaluation of the vaccine or interpretation of study results
Clareo Health | Study to Evaluate the Safety of a Bivalent Vaccine of New 6:2 Influenza Virus Reassortants in Healthy Adults
