Status:
COMPLETED
A Clinical Study to Evaluate TV003 in Healthy Adults in Taiwan
Lead Sponsor:
Medigen Vaccine Biologics Corp.
Conditions:
Dengue
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
The goal of this study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan
Eligibility Criteria
Inclusion
- Adult male or female between 20 and 70 years of age
- Good general health as determined by physical examination, laboratory screening, and review of medical history
- Available for the duration of the study
- Willingness to sign the informed consent document
- Female of childbearing potential willing to use effective contraception for the duration of the trial
Exclusion
- Females currently pregnant, as determined by positive β- human choriogonadotropin (HCG) test, and/or breast-feeding.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
- Behavioral, cognitive, or psychiatric disease
- Below lower limit of normal for absolute neutrophil count
- Any significant alcohol or drug abuse in the past 12 months
- History of a severe allergic reaction or anaphylaxis
- Self-reported systemic hypersensitivity to any of the vaccine components
- Severe asthma
- Known HIV, Hepatitis B or hepatitis C
- Any known immunodeficiency syndrome
- Use of anticoagulant medications
- Receive chronic administration of immunosuppressant drugs within 6 months prior to the administration of the study vaccine
- Use of any investigational product within 30 days before study vaccination or at any time during the study
- Asplenia
- Receive administration of immunoglobulins and/or any blood products within 12 months preceding the administration of the study vaccine or at any time during the study
- Fever or suspected fever within 72 hours prior to vaccination or tympanic temperature greater than 38°C on the day of vaccination
- Receive administration of any licensed live attenuated vaccines within 30 days preceding the administration of the study vaccine and ending 30 days after
- Receive administration of any licensed inactivated vaccines within 14 days preceding the administration of the study vaccine and ending 14 days after
- 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
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2019
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03485144
Start Date
December 12 2017
End Date
May 10 2019
Last Update
August 14 2019
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan