Dengue fever is caused by an infection with the dengue virus. Vaccination with TDV can help prevent dengue fever. The main purpose of this study is to learn about TDV's ability to create an immune response in adults, adolescents, and children administered. 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. Participants will be in this study for approximately 270 days (9 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
187
PS Clinic
Fukuoka, Fukuoka, Japan
Saitama City Hospital
Saitama-shi, Saitama, Japan
Sumida Hospital
Sumida-ku, Tokyo, Japan
OKURA Otolaryngology Clinic
Toshima-ku, Tokyo, Japan
Tamura Clinic
Tokyo, Japan
Percentage of Seropositive Participants for Each of the 4 Dengue Virus Serotypes on Day 120
Seropositivity is defined as a reciprocal neutralizing titer greater than or equal to (\>=) 10. The 4 dengue virus serotypes (DENV) are DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: Day 120
Percentage of Seropositive Participants for Each of the 4 Dengue Virus Serotypes on Day 1, Day 30, Day 90 and Day 270
Seropositivity is defined as a reciprocal neutralizing titer \>=10. 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 (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Virus Serotypes on Day 1, Day 30, Day 90, Day 120 and Day 270
GMTs of neutralizing antibodies will be measured by microneutralization Test (MNT) 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
Percentage of Seropositive Participants for Multiple (2, 3, or 4) Dengue Serotypes on Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity is defined as a reciprocal neutralizing titer \>=10 for multiple dengue serotypes (2, 3, or 4).
Time frame: Day 1, Day 30, Day 90, Day 120 and Day 270
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 days After Vaccination at Day 1 and Day 90
The solicited local (at injection site) AEs includes pain, erythema, and swelling.
Time frame: For 7 days after vaccination at Day 1 and Day 90
Number of Participants with Solicited Local (Injection Site) AEs by Severity for 7 days After Vaccination at Day 1 and Day 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The solicited local (at injection site) AEs includes pain, erythema, and swelling. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time frame: For 7 days after vaccination at Day 1 and Day 90
Number of Participants With Solicited Systemic AEs for 14 days After Vaccination at Day 1 and Day 90
The solicited systemic AEs for less than (\<) 6 years of age will be fever, irritability/fussiness, drowsiness, and loss of appetite; and for \>=6 years of age will be asthenia, fever, headache, malaise, and myalgia.
Time frame: For 14 days after vaccination at Day 1 and Day 90
Number of Participants With Solicited Systemic AEs by Severity for 14 days After Vaccination at Day 1 and Day 90
The solicited systemic AEs for \<6 years of age will be fever, irritability/fussiness, drowsiness, and loss of appetite; and for \>=6 years of age will be asthenia, fever, headache, malaise, 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: For 14 days after vaccination at Day 1 and Day 90
Percentage of Participants With Any Unsolicited AEs for 28 days After Vaccination at Day 1 and 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 Investigational Medicinal Product \[IMP\] administration).
Time frame: For 28 days after vaccination at Day 1 and Day 90
Percentage of Participants With Serious Adverse Event (SAE)
A 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)
Percentage of Participants With Medically Attended AEs (MAAEs)
MAAEs are defined as AEs leading to an unscheduled visit or by a healthcare professional including visits to an emergency department (medically attended visits), but not fulfilling seriousness criteria.
Time frame: From first vaccination on Day 1 through the end of trial (up to Day 270)