The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60 years in non-endemic country(ies) for dengue.
The vaccine tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). The primary objective of this trial is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive lots of TDV in healthy participants in non-endemic country(ies) for dengue. The study will enroll approximately 924 healthy participants. Participants will be randomized in 2:2:2:1 to one of 4 trial groups to receive TDV (Lots 1, 2 or 3) or placebo: * TDV 0.5 mL subcutaneous injection OR * Placebo normal saline solution (0.9% NaCl) for injection. In each trial group, all participants will receive 2 doses of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3). Immunogenicity will be assessed in participants included in the immunogenicity subset (TDV groups: 176 participants each and placebo group: 88 participants) and safety will be assessed in all participants in each group. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 270 days. Participants will make multiple visits to the clinic including a final visit at Day 270.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
923
Optimal Research
Huntsville, Alabama, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Advanced Clinical Research
Boise, Idaho, United States
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset
GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: 1 month post second dose (Day 120)
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset
Seropositivity was defined as a reciprocal neutralizing titer ≥ 10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: 1 month post second dose (Day 120) and 6 months post second dose (Day 270)
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset
GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: 6 months post second dose (Day 270)
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (\<25 mm, mild: \>25 - ≤50 mm, moderate: \>50 - ≤100 mm, severe: \>100 mm) and swelling (edema/induration) (\<25 mm, mild: \>25 - ≤50 mm, moderate: \>50 - ≤100 mm, severe: \>100 mm ). The percentages were rounded off to the first decimal place.
Time frame: Within 7 Days of each Vaccination (day of vaccination + 6 days)
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Optimal Research
Peoria, Illinois, United States
Synexus Limited- Council Bluffs
Council Bluffs, Iowa, United States
Heartland Research Associates LLC - Augusta
Augusta, Kansas, United States
Heartland Research Associates LLC
Park City, Kansas, United States
Optimal Research
Rockville, Maryland, United States
Synexus Limited - Minneapolis
Edina, Minnesota, United States
Synexus Limited - St. Louis
St Louis, Missouri, United States
...and 4 more locations
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
Solicited systemic AEs include fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. Solicited systemic AEs (headache, asthenia, malaise and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it. The percentages were rounded off to the first decimal place.
Time frame: Within 14 Days of each Vaccination (day of vaccination + 13 days)
Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
Time frame: Within 28 days (day of vaccination + 27 days) after each vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event that may require intervention to prevent any of the above mentioned criteria and/or may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. The percentages were rounded off to the first decimal place.
Time frame: From the first vaccination on Day 1 until the end of the trial (Day 270)
Percentage of Participants With Medically Attended Adverse Events (MAAEs)
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria. The percentages were rounded off to the first decimal place.
Time frame: From the first vaccination on Day 1 until the end of the trial (Day 270)