TDV
BiologicalTDV SC injection.
Other names: TAK-003
NCT Number: NCT06741683
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).
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Notify Me4 year–60 year
All sexes
Interventional
Phase 2 / Phase 3
PS Clinic, Fukuoka, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: In principle, oral temperature should be measured for body temperature. In cases where it is difficult to measure oral temperature, such as in young children, underarm (axillary) temperature may be used instead.
TDV SC injection.
Other names: TAK-003
Placebo SC injection.
Other names: Placebo SC injection.
Time frame: 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 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, 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
Seropositivity is defined as a reciprocal neutralizing titer >=10 for multiple dengue serotypes (2, 3, or 4).
Time frame: 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
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 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
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 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: From first vaccination on Day 1 through the end of trial (up to Day 270)
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)
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.
Takeda
Industry
A Randomized, Double-Blind, Placebo-Controlled (Participants Aged 18 to 60 Years) and Open-Label (Participants Aged 4 to 17 Years), Phase 2/3 Trial to Evaluate the Immunogenicity and Safety of 2 Doses of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to Healthy Adults, Adolescents, and Children in Japan
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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