Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The TDV in current formulation has been approved by health authorities in many countries around the world. The main aim of the study is to confirm that the TDV new formulation induces the similar immune response as approved TDV. Healthy adults who live in an area in which dengue fever does not occur will receive 2 TDV vaccinations 3-months apart with either the new or the current TDV. Blood samples will be taken before and after the vaccinations. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 5 times.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
496
TDV subcutaneous injection
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
Emeritus Research Sydney
Botany, New South Wales, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
Veritus Research
Bayswater, Victoria, Australia
Emeritus Research Camberwell (Melbourne)
Camberwell, Victoria, Australia
Geometric Mean Titers (GMTs) of Neutralizing Antibodies (By MNT) Against Each of the 4 Dengue Serotypes at Day 120 In the TDV (New) And TDV (Current) Groups
GMTs of neutralizing antibodies will be measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. GMTs of neutralizing antibodies (by MNT) against each of the 4 dengue serotypes at Day 120 in the TDV (new) and TDV (current) groups will be reported.
Time frame: At Day 120
GMTs of Neutralizing Antibodies (By MNT) Against Each of the 4 Dengue Serotypes at Day 270 In the TDV (New) And TDV (Current) Groups
GMTs of neutralizing antibodies will be measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. GMTs of neutralizing antibodies (by MNT) against each of the 4 dengue serotypes at Day 270 in the TDV (new) and TDV (current) groups will be reported.
Time frame: At Day 270
Seropositivity Rates Against Each of the 4 Dengue Serotypes at Day 120 And Day 270 In the TDV (New) And TDV (Current) Groups
Seropositivity rate is defined the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a neutralizing 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: At Days 120 and 270
Seropositivity Rates Against Multiple (2, 3 or 4) Dengue Virus Serotypes at Day 120 And Day 270 In the TDV (New) And TDV (Current) Groups
Seropositivity rate is defined the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a neutralizing 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: At Days 120 and 270
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 days Post Vaccination (Overall and by Severity)
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 of severity will be graded by investigator as 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 for 14 days Post Vaccination (Overall and by Severity)
Solicited systemic AEs include fever (body temperature greater than or equal to \[\>=\] 38-degree Celsius \[C\], drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as 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 Adverse Events (AEs) for 28 days Post Vaccination
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
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: From first vaccination (Day 1) through end of study (Day 270)
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