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

Who is this study for? Patients with Dengue Fever
What treatments are being studied? Tetravalent Live Attenuated Dengue Vaccine Admixture TV005
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 70
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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.

Locations
Other Locations
Taiwan
National Taiwan University Hospital
Recruiting
Taipei
Contact Information
Primary
Shan-Chwen Chang
changsc@ntu.edu.tw
+886-2-2312-3456
Backup
Jann-Tay Wang
wang.jt1968@gmail.com
+886-2-2312-3456
Time Frame
Start Date: October 15, 2018
Estimated Completion Date: June 30, 2023
Participants
Target number of participants: 252
Treatments
Experimental: Tetravalent live attenuated dengue vaccine admixture TV005
Tetravalent live attenuated dengue vaccine admixture TV005
Placebo Comparator: placebo
Plasma-Lyte A
Related Therapeutic Areas
Sponsors
Collaborators: Centers for Disease Control, Taiwan
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov

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