The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,271
0.5 mL SC dose of V181 High-Potency vaccine
0.5 mL SC dose of V181 Mid-Potency vaccine
0.5 mL SC dose of V181 Low-Potency vaccine
0.5 mL SC dose of placebo
California Research Foundation ( Site 0114)
San Diego, California, United States
Advanced Medical Research Institute ( Site 0115)
Miami, Florida, United States
Rochester Clinical Research, Inc. ( Site 0122)
Rochester, New York, United States
University of Texas Medical Branch ( Site 0113)
Galveston, Texas, United States
IMA Clinical Research San Antonio ( Site 0111)
San Antonio, Texas, United States
Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT)
A dengue VRNT was conducted to assess neutralizing antibody Geometric Mean Titers (GMTs) for each of the 4 dengue vaccine serotypes (DENV1, DENV2, DENV3, and DENV4) in specimens collected from participants on Day 28 post-vaccination.
Time frame: Day 28 post-vaccination
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator.
Time frame: Up to 28 days post-vaccination
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs include pain, erythema (redness), and swelling.
Time frame: Up to 5 days post-vaccination
Percentage of Participants With Solicited Systemic AEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include rash, headache, fatigue (tiredness), pyrexia (oral temperature ≥100.4 °F or 38.0 °C), myalgia (muscle pain), and arthralgia (joint pain).
Time frame: Up to 28 days post-vaccination
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Alliance for Multispecialty Research LLC (AMR - Norfolk) ( Site 0123)
Norfolk, Virginia, United States
Paratus Clinical Research Western Sydney ( Site 0007)
Blacktown, New South Wales, Australia
Emeritus Research ( Site 0010)
Botany, New South Wales, Australia
USC Clinical Trials Moreton Bay ( Site 0001)
Morayfield, Queensland, Australia
USC Clinical Trials Sunshine Coast ( Site 0005)
Sippy Downs, Queensland, Australia
...and 22 more locations