Phase II, Randomized, Double-blind, Clinical Tial of the Safety and Immunogenicity of a Tetravalent Dengue Virus Vaccine Admixture TV005 in the Elderly Aged 50-70 Years in Taiwan
Phase II, randomized, double-blind, placebo-controlled study of the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 in the elderly in Taiwan
• Man or non-pregnant / non-lactating woman between the ages of 50 years and 70 years at the time of enrollment into the study.
• 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).
• Subject who allow to access to their Medical Record.
• Subjects whose residence is in Taiwan who will remain available for the duration of the study, approximately 3 years following the first vaccination.
• Good general health as determined by physical examination, laboratory screening, and review of medical history.
• An informed consent form signed and dated by the subject.
• 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.