Eligibility Details:
Inclusion Criteria:
1. Aged between 18 and 49 years of age (inclusive).
2. Female subjects must fulfill one of the following: (i) not able to bear children
because she has been surgically sterilized (tubal ligation or hysterectomy) or (ii)
agrees to practice effective methods of contraception that may include, but are not
limited to abstinence, barrier methods, monogamous relationship with vasectomized
partner, birth control pills, patches, hormonal shots or hormonal implants, NuvaRing
and IUDs (intrauterine devices), from 30 days prior to study enrollment through 30
days following receipt of the last dose of vaccine.
3. Female subjects of childbearing potential must have a negative pregnancy test (urine
or serum) within 24 hours prior to vaccination.
4. The subject must be in good health, as determined by: vital signs (heart rate >55 to
<100 bpm; blood pressure: systolic ≥ 90 mm Hg and ≤150 mm Hg; diastolic ≤ 90 mm Hg;
oral temperature <100.0ºF); medical history; and targeted physical examination, when
necessary, based on medical history. Stable medical condition is defined as: no recent
increase in prescription medication, dose, or frequency of medication in the last 3
months and health outcomes of the specific disease are considered to be within
acceptable limits in the last 6 months.
5. The subject is able to understand and comply with the planned study procedures,
including being available for all study visits.
6. The subject has provided informed consent prior to any study procedures.
7. Subjects who have not received seasonal flu vaccine for the current year.
Exclusion Criteria
1. Subject report of known hypersensitivity to allergy to components of the study vaccine
or other components of the study vaccine.
2. Subject report of known latex allergy
3. Subject report of a history of severe reactions following previous immunization with
licensed or unlicensed influenza virus vaccines.
4. Subject report of a history of Guillain-Barre syndrome within 6 weeks of receipt of a
previous influenza vaccine.
5. The subject is a woman who is pregnant or breastfeeding or intends to become pregnant
during the study period between enrollment and 30 days following receipt of vaccine.
6. The subject is immunosuppressed as a result of an underlying illness or treatment with
immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation
therapy within the preceding 36 months.
7. The subject has an active neoplastic disease (excluding non-melanoma skin cancer or
prostate cancer that is stable in the absence of therapy) or a history of any
hematological malignancy. For this criterion, "active" is defined as having received
treatment within the past 5 years.
8. The subject has long-term (greater than 2 weeks) use of oral or parenteral steroids,
or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or
equivalent) within the preceding 6 months (nasal and topical steroids are allowed).
9. The subject received immunoglobulin or another blood product within the 3 months prior
to enrollment in this study.
10. The subject has received an inactivated vaccine within the 2 weeks or a live vaccine
within the 4 weeks prior to enrollment in this study or plans to receive another
vaccine within the next 28 days.
11. The subject has an acute or chronic medical condition that, in the opinion of the
investigator or appropriate sub-investigator, would render vaccination unsafe or would
interfere with the evaluation of responses. These conditions include any acute or
chronic medical disease or conditions defined as persisting for 3 months (defines ad
90 days) or longer, that would place the subject at an unacceptable risk of injury,
render the subject unable to meet the requirements of the protocol, or may interfere
with the evaluation of responses of the subject's successful completion of the study.
12. Subjects with an active infection or that has an acute illness or an oral temperature
greater than 99.9F (37.7C) within 3 days prior to enrollment or vaccination. Subjects
who had an acute illness that was treated symptoms resolved are eligible to enroll as
long as treatment is completed and symptoms resolved > 3 days prior to enrollment.
13. The subject is currently participating or plans to participate in a study that
involves an experimental agent (vaccine, drug, biologic, device, blood product, or
medication) or has received an experimental agent within 1 month prior to enrollment
in this study, or expects to receive another experimental agent during participation
in this study, or intends to donate blood during the study period.
14. The subject has any condition that would, in the opinion of the site investigator,
place the subject at an unacceptable risk of injury or render the subject unable to
meet the requirements of the protocol.
15. Have been hospitalized for psychiatric illness, history of suicide attempt, or
confinement for danger to self or others, within the past 10 years.
16. The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe
(disabling) chronic psychiatric diagnosis, or is receiving psychiatric drugs. Subjects
who are receiving a single antidepressant drug and are stable for at least 3 months
prior to enrollment without decompensation are allowed enrollment into the study.
17. The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment.
18. The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C
infection.
19. The subject has any condition that the principal investigator (PI) believes may
interfere with successful completion of the study.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
