Status:
COMPLETED
Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years
Lead Sponsor:
Takeda
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine (TDV) (previously DENVax) administered subcutaneously in healthy adults and children. In addition the antibody ...
Detailed Description
The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to assess safety and immunogenicity in healthy adults and children living in dengue endemic countries. The study ...
Eligibility Criteria
Inclusion
- In good health as determined by medical history, physical examination including height and weight
- Normal safety laboratory values at screening
- Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies \& Hepatitis B surface antigen
- Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception
- Weight: Within 1.3 times of the upper limit of local normal age-adjusted body mass index (BMI)
Exclusion
- For participants ≥12 years, clinically significant electrocardiogram (ECG) findings
- History of significant dermatologic (skin) disease within last 6 months
- History of diabetes mellitus
- History of thymic pathology, thymectomy, myasthenia or any immunodeficiency
- History of recurring headaches or migraines
- Hypersensitivity to any vaccine
- For participants ≥12 years, positive urine screen for cocaine, amphetamines, opiates, or cannabinoids
- History of alcohol abuse
- Pregnant or lactating female
Key Trial Info
Start Date :
November 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2016
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01511250
Start Date
November 16 2011
End Date
April 15 2016
Last Update
April 12 2023
Active Locations (8)
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1
Program For The Study and Control of Tropical Diseases
Medellín, Colombia
2
Ponce School of Medicine, CAIMED Center
Ponce, Puerto Rico, 716
3
University of Puerto Rico School of Medicine
San Juan, Puerto Rico, 00935
4
Latin Clinical Trial Center
San Juan, Puerto Rico, 909