| Eligibility |
Inclusion Criteria:
1. Man or non-pregnant / non-lactating woman between the ages of 50 years and 70 years at
the time of enrollment into the study.
2. Subjects who the investigator believes can and will comply with the requirements of
the protocol (e.g., completion of the diary cards, return for follow-up visits).
3. Subject who allows to access to their Medical Record.
4. Subjects whose residence is in Taiwan who will remain available for the duration of
the study, approximately 3 years following the first vaccination.
5. Good general health as determined by physical examination, laboratory screening, and
review of medical history.
6. An informed consent form signed and dated by the subject.
7. If the subject is female, she must be of non-childbearing potential, i.e. surgically
sterilized or one year post-menopausal; or, if of childbearing potential, she must be
abstinent or have used adequate contraceptive precautions (i.e. intrauterine
contraceptive device; condom and spermicide combination, oral contraceptives or other
equivalent hormonal contraception, e.g. progestin implantable, cutaneous hormonal
patch or injectable contraceptives) for 30 days prior to vaccination, have a negative
pregnancy test prior to vaccination and must agree to continue such precautions for 90
days after completion of the vaccination. For male subject, he must be abstinent or
use a condom together with spermicide for 14 days after completion of the vaccination.
Exclusion Criteria:
1. Pregnant or lactating female or female planning to become pregnant within 90 days of
receiving an investigational product or planning to discontinue abstinence or
contraceptive precautions within 90 days of receiving an investigational product.
2. Acute or chronic, clinically significant neurological, pulmonary, cardiovascular,
hepatic, renal, autoimmune, hematologic, endocrine disease or functional defect, as
determined by history, physical examination or screening tests that in the opinion of
the investigator would, will jeopardize the safety or rights of a subject
participating in the trial or would render the subject unable to comply with the
protocol.
3. Psychiatric, behavioral disorder, or seizures (with the exception of a single febrile
seizure in childhood) that in the opinion of the investigator, will affect the ability
of the subject to understand and cooperate with the requirements of the study
protocol.
4. Self-reported or suspected congenital or acquired immunodeficiency, or asplenia; or
receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation
therapy within the preceding 6 months, or long-term systemic corticosteroid therapy
(prednisone or equivalent, = 0.5 mg/kg/day or 20 mg/day, for more than 2 consecutive
weeks within the past 3 months). Inhaled and topical steroids are allowed.
5. HIV infection by screening (by HIV Ag/Ab combo test or HIV Ab test) and confirmatory
assays (by Western blot), Hepatitis C virus (HCV) infection by Anti-HCV antibody, or
Hepatitis B virus (HBV) infection by Hepatitis B surface antigen (HBsAg) screening or,
unwilling to allow HIV, HCV and HBV testing.
6. Screening laboratory values of hemoglobin <9.5 gm/dL in female adults or <11 gm/dL in
male adults, neutrophil <1,000 mm3, platelet < 100,000/mm3, Creatinine >1.5 mg/dL,
Bilirubin-T >1.5 times of upper limit, or ALT > 2 times of upper limit.
7. History of allergic disease/reaction likely to be exacerbated by any component of the
vaccine, or any history of a severe allergic reaction or anaphylaxis.
8. Current alcohol abuse or drug addiction that might interfere with the ability to
comply with trial procedures.
9. Any 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.
10. Planned administration of any vaccine not foreseen by the study protocol, during the
period starting from 30 days before the study vaccine and ending 30 days after study
vaccination; with the exceptions of the inactivated influenza vaccine or the
inactivated rabies vaccine (without administration of immunoglobulin) administered.
11. Use of any investigational or non-registered drug or vaccine other than the study
vaccine within 30 days preceding the study vaccine/placebo or planned use at any time
during the study period or history of having received any investigational dengue
vaccine at any previous time.
12. Administration of immunoglobulins and/or blood products within 90 days preceding the
study vaccine dose or planned administration at any time during the study period,
which might interfere with assessment of the immune response. Or administration of
killed vaccine within 14 days, or attenuated vaccine within 28 days.
13. A planned or anticipated move to a location that will prohibit participating in the
trial for the 12-month duration and unavailable for schedule visit during 2nd and 3rd
year follow-up.
14. Potential volunteers who do not have easy access to a fixed or mobile telephone.
15. Any subject identified as a site employee of the Investigator or study clinic, with
direct involvement in the proposed study or other studies under the direction of that
Investigator or study clinic, as well as any family member (i.e., immediate, husband,
wife and their children, adopted or natural) of the clinic employees or the
Investigator.
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