A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)
NCT Number: NCT06579755
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Dengue Fever
Interventions: BIOLOGICAL: TDV|OTHER: Placebo
Sponsor: Takeda
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2025-03-17
Completion Date: 2026-03-14

Summary:
Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition.

In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first).

During the study, participants will visit their study clinic 5 times.

Primary Outcome Measures: Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1, An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medical product (IMP); it does not necessarily have to have a causal relationship with IMP administration. Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration., Within 7 days post-vaccination at Day 1|Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 90, Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration., Within 7 days post-vaccination at Day 90|Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1, Solicited systemic AEs include fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius \[C\], asthenia, malaise, headache, and myalgia., Within 14 days post-vaccination at Day 1|Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90, Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia., Within 14 days post-vaccination at Day 90|Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 1, Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe., Within 7 days post-vaccination at Day 1|Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 90, Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe., Within 7 days post-vaccination at Day 90|Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1, Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe., Within 14 days post-vaccination at Day 1|Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 90, Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe., Within 14 days post-vaccination at Day 90|Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1, An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day IMP administration)., Within 28 days post-vaccination at Day 1|Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90, An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day of IMP administration)., Within 28 days post-vaccination at Day 90|Percentage of Participants with a Serious Adverse Event (SAE), An SAE is 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., From first vaccination on Day 1 through the end of trial (up to Day 270)|Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of the 4 Dengue Virus Serotypes at Day 120, GMTs of neutralizing antibodies will be measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes in all participants. The 4 dengue virus serotypes are dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4., At Day 120
Secondary Outcome Measures: Number of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities), Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration., Within 7 days post-vaccination at Day 1 and Day 90|Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities), Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia., Within 14 days post-vaccination at Day 1 and Day 90|Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 days Post Vaccination at Day 1 and Day 90 (With Comorbidities), Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe., Within 7 days post-vaccination at Day 1 and Day 90|Percentage of Participants with Solicited Systemic AEs by Severity (With Comorbidities), Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe., Within 14 days post-vaccination at Day 1 and Day 90|Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination (With Comorbidities), An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day IMP administration)., Within 28 days post-vaccination at Day 1 and Day 90|Percentage of Participants with a SAE (With Comorbidities), An SAE is 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., From first vaccination on Day 1 through the end of trial (up to Day 270)|Geometric Mean Titers by MNT for Each of the 4 Dengue Virus Serotypes, GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 dengue serotypes in all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4., Day 1, Day 30, Day 90 and Day 270|Geometric Mean Titers by MNT for Each of the 4 Dengue Virus Serotypes (With Comorbidities), GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 dengue serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4., Day 1, Day 30, Day 90, Day 120 and Day 270|Seropositivity Rate for Each of the 4 Dengue Virus Serotypes, Seropositivity rate is defined as the percentage of participants with MNT titer \>=10 against each of the four dengue virus serotypes in all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4., Day 1, Day 30, Day 90, Day 120 and Day 270|Seropositivity Rate for Each of the 4 Dengue Virus Serotypes (With Comorbidities), Seropositivity rate is defined as the percentage of participants with MNT titer \>=10 against each of the four dengue virus serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4., Day 1, Day 30, Day 90, Day 120 and Day 270|Seropositivity Rate for Multiple (2, 3, or 4) Dengue Virus Serotypes, Seropositivity rate is defined as the percentage of participants with MNT titer \>=10 against multiple (2, 3, or 4) dengue virus serotypes in all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4., Day 1, Day 30, Day 90, Day 120 and Day 270|Seropositivity Rate for Multiple (2, 3, or 4) Dengue Virus Serotypes (With Comorbidities), Seropositivity rate is defined as the percentage of participants with MNT titer \>=10 against multiple (2, 3, or 4) dengue virus serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4., Day 1, Day 30, Day 90, Day 120 and Day 270