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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
800
TDV SC injection.
Placebo SC injection.
Fundacion Huesped - PPDS
Buenos Aires, Argentina
RECRUITINGAssociacao Obras Sociais Irma Dulce Hospital Santo Antonio
Salvador, Estado de Bahia, Brazil
NOT_YET_RECRUITINGFundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, Brazil
NOT_YET_RECRUITINGSingapore General Hospital (SGH)
Singapore, Singapore
NOT_YET_RECRUITINGTan Tock Seng Hospital
Singapore, Singapore
NOT_YET_RECRUITINGRamathibodi Hospital
Ratchathewi, Bangkok, Thailand
NOT_YET_RECRUITINGHospital for Tropical Diseases
Ratchathewi, Krung Thep Maha Nakhon-Bangkok, Thailand
NOT_YET_RECRUITINGNumber 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At Day 120
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Within 28 days post-vaccination at Day 1 and Day 90
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1, Day 30, Day 90, Day 120 and Day 270