Dengue Fever
Conditions
Keywords
Vaccine
Brief summary
The purpose of this study is to assess the post-vaccination neutralizing antibody response against each dengue serotype by vaccine group.
Detailed description
The vaccine being tested in this study was Takeda's Tetravalent Dengue Vaccine Candidate (TDV). TDV is being tested to protect people against dengue fever. This study looked at safety and the titers of antibodies to dengue fever induced in people who were administered a high-dose of TDV (HD-TDV) compared to TDV. The study enrolled 351 patients. Before being assigned to a treatment group participants were screened for previous exposure to the dengue virus using a Dengue immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA). Participants were randomly assigned in 1:1 ratio (by chance) to one of the two treatment groups-which remained undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * HD-TDV 0.5 mL subcutaneous injection * TDV 0.5 mL subcutaneous injection All participants received a single injection on Day 1. Participants were asked to record any symptoms that may or may not be related to the vaccine or the injection site in a diary card for 28 days after vaccination. This multi-center trial was conducted in Singapore. The overall time of participation in this study was 12 months. Participants made multiple visits to the clinic, including a final visit 1 year after receiving their dose of TDV.
Interventions
TDV subcutaneous injection
BIOLOGICALTakeda's High-Dose Tetravalent Dengue Vaccine Candidate (HD-TDV)
High-dose TDV subcutaneous injection
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participant signs and dates a written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements. 2. Is aged 21 to 45 years of age, inclusive. 3. Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator. 4. Can comply with trial procedures and are available for the duration of follow-up. 5. Has self-declared as never having been vaccinated against Yellow Fever or Japanese Encephalitis Virus.
Exclusion criteria
1. Has febrile illness (temperature ≥38°C or ≥100.4°F) or moderate or severe acute illness or infection at the time of enrollment. 2. Has history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose an additional risk to the participant due to participation in the trial, including but not limited to: 1. Known hypersensitivity or allergy to any of the vaccine components. 2. Female participants who are pregnant or breastfeeding. 3. Individuals with any serious chronic or progressive disease according to judgment of the Investigator (e.g. neoplasm, insulin-dependent diabetes, cardiac, renal or hepatic disease, neurologic or seizure disorder or Guillain-Barré syndrome). 4. Known or suspected impairment/alteration of immune function, including: * i. Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month 0) (use of inhaled, intranasal, or topical corticosteroids is allowed). * ii. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥ 2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month 0). * iii. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (Month 0) or planned administration during the trial. * iv. Receipt of immunostimulants within 60 days prior to Day 1(Month 0). * v. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (Month 0). * vi. Human immunodeficiency virus (HIV) infection and HIV-related diseases. * vii. Hepatitis C virus (HCV) infection. * viii. Genetic immunodeficiency. 3. Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccine within 28 days after Day 1 (Month 0). 4. Has participated in any clinical trial with another investigational product 30 days prior to Day 1 (Month 0) or intent to participate in another clinical trial at any time during the conduct of this trial. 5. Has previously participated in any clinical trial of a dengue candidate vaccine, or previous receipt of a dengue vaccine. 6. Is first-degree relative of individuals involved in trial conduct. 7. For females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (Month 0). 1. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: bilateral tubal ligation (at least 1 year previously), bilateral oophorectomy (at least 1 year previously) or hysterectomy. 2. Acceptable birth control methods are defined as one or more of the following: * i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring). * ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse. * iii. Intrauterine device (IUD). * iv. Monogamous relationship with vasectomized partner (partner must have been vasectomized for at least six months prior to Day 1 \[Month 0\]). 8. Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method from signing the informed consent up to 6 weeks post-vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 | Day 365 | Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4. |
| Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 | Day 15 | GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by microneutralization test \[MNT\]. |
| Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 | Day 30 | GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT. |
| Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 | Day 90 | GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT. |
| Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 | Day 180 | GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT. |
| Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 | Day 365 | GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT. |
| Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 | Day 15 | Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4. |
| Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 | Day 30 | Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4. |
| Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 | Day 90 | Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4. |
| Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 | Day 180 | Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Within 14 days after Vaccination | Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, asthenia, malaise and myalgia. Severity grades were: Grade 0: none, Grade 1: mild (no interference with daily activity), Grade 2: moderate (interference with daily activity with or without treatment), Grade 3: severe (prevents normal daily activity with or without treatment). A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. |
| Number of Participants With at Least One Unsolicited Adverse Events (AEs) Following Vaccination | Within 28 days after Vaccination | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a study vaccine; it does not necessarily have to have a causal relationship with study vaccine administration. |
| Number of Participants With Serious Adverse Events (SAEs) | From first vaccination through end of study (Day 365) | A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose 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. |
| Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Days 15, 30, 90, 180 and 365 | Baseline dengue seropositivity was based on the microneutralization test (MNT) result and was defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. The four DENV serotypes are DENV-1, DENV-2, DENV-3, and DENV-4. |
| Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Days 15, 30, 90, 180, and 365 | Baseline dengue seropositivity was based on the MNT result and was defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. Seropositive rate was defined as a reciprocal neutralizing titer ≥ 10. Seropositivity was assessed for the four Dengue serotypes are DENV-1, DENV-2, DENV-3, and DEN-4. |
| Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Days 5, 7, 9, 11, 15, 17, 21 and 30 | Vaccine Viremia was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay. |
| Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Days 5, 7, 9, 11, 15, 17, 21 and 30 | The duration of vaccine viremia for each vaccine strain was defined as the date when vaccine viremia was last detected (positive result) to date when vaccine viremia was first detected (positive result) + 1 day. It was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay. |
| Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Days 5, 7, 9, 11, 15, 17, 21 and 30 | Vaccine Viremia was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay. |
| Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Within 7 days after Vaccination | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain \[Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)\], erythema \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\] and swelling \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\]. |
Countries
Singapore
Participant flow
Recruitment details
Participants took part in the study at 3 investigative sites into Singapore from 03 June 2015 to 18 September 2017.
Pre-assignment details
Healthy volunteers were enrolled and randomized in 1:1 ratio to receive single injection of either high-dose tetravalent dengue vaccine (HD-TDV) or tetravalent dengue vaccine (TDV).
Participants by arm
| Arm | Count |
|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) High-dose Tetravalent Dengue Vaccine \[HD-TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\*10\^4 plaque forming units (PFU), 5\*10\^4 PFU, 1\*10\^5 PFU, and 3\*10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively. | 176 |
| Tetravalent Dengue Vaccine (TDV) Tetravalent Dengue Vaccine \[TDV\], 0.5 mL, subcutaneous injection on Day 1. TDV comprised one molecularly-characterized and cloned TDV-2 live attenuated dengue virus strain and three recombinant live attenuated dengue virus strains: TDV-1, TDV-3 and TDV-4. TDV contained 2\*10\^4 plaque forming units (PFU), 5\*10\^3 PFU, 1\*10\^5 PFU, and 3\*10\^5 PFU of TDV-1, TDV-2, TDV-3 and TDV-4 respectively. | 175 |
| Total | 351 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 7 |
| Overall Study | Pregnancy | 2 | 0 |
| Overall Study | Reason not Specified | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 8 |
Baseline characteristics
| Characteristic | Tetravalent Dengue Vaccine (TDV) | High-dose Tetravalent Dengue Vaccine (HD-TDV) | Total |
|---|---|---|---|
| Age, Continuous | 30.9 years STANDARD_DEVIATION 6.74 | 31.2 years STANDARD_DEVIATION 6.52 | 31.0 years STANDARD_DEVIATION 6.63 |
| Baseline Seropositivity Rate for Each Serotype DENV-1 | 48.6 percentage of participants | 48.6 percentage of participants | 48.6 percentage of participants |
| Baseline Seropositivity Rate for Each Serotype DENV-2 | 50.3 percentage of participants | 47.4 percentage of participants | 48.9 percentage of participants |
| Baseline Seropositivity Rate for Each Serotype DENV-3 | 46.3 percentage of participants | 44.0 percentage of participants | 45.1 percentage of participants |
| Baseline Seropositivity Rate for Each Serotype DENV-4 | 40.6 percentage of participants | 41.7 percentage of participants | 41.1 percentage of participants |
| Baseline Seropositivity Status Seronegative for all Dengue Serotypes | 80 Participants | 83 Participants | 163 Participants |
| Baseline Seropositivity Status Seropositive for at least one Dengue Serotype | 95 Participants | 92 Participants | 187 Participants |
| Body Mass Index (BMI) | 23.86 kg/m^2 STANDARD_DEVIATION 4.681 | 24.51 kg/m^2 STANDARD_DEVIATION 5.049 | 24.18 kg/m^2 STANDARD_DEVIATION 4.873 |
| Height | 164.33 cm STANDARD_DEVIATION 9.505 | 164.26 cm STANDARD_DEVIATION 9.714 | 164.29 cm STANDARD_DEVIATION 9.597 |
| Race/Ethnicity, Customized Asian | 172 Participants | 173 Participants | 345 Participants |
| Race/Ethnicity, Customized Multiracial | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic or Latino | 175 Participants | 176 Participants | 351 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment Singapore | 175 Participants | 176 Participants | 351 Participants |
| Sex: Female, Male Female | 91 Participants | 103 Participants | 194 Participants |
| Sex: Female, Male Male | 84 Participants | 73 Participants | 157 Participants |
| Weight | 64.96 kg STANDARD_DEVIATION 16.295 | 66.44 kg STANDARD_DEVIATION 16.184 | 65.70 kg STANDARD_DEVIATION 16.234 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 176 | 0 / 175 |
| other Total, other adverse events | 45 / 176 | 49 / 175 |
| serious Total, serious adverse events | 3 / 176 | 3 / 175 |
Outcome results
Primary
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15
GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by microneutralization test \[MNT\].
Time frame: Day 15
Population: Per-protocol set (PPS) included all randomized participants who received study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 | DENV-1 | 156.2 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 | DENV-2 | 183.0 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 | DENV-3 | 113.5 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 | DENV-4 | 41.2 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 | DENV-4 | 33.9 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 | DENV-1 | 110.2 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 | DENV-3 | 69.0 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 | DENV-2 | 117.6 Titer |
Primary
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180
GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.
Time frame: Day 180
Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 | DENV-1 | 379.4 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 | DENV-2 | 2585.5 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 | DENV-3 | 236.2 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 | DENV-4 | 91.0 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 | DENV-4 | 92.9 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 | DENV-1 | 312.2 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 | DENV-3 | 161.0 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180 | DENV-2 | 1235.0 Titer |
Primary
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30
GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.
Time frame: Day 30
Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 | DENV-1 | 771.0 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 | DENV-2 | 8640.3 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 | DENV-3 | 390.6 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 | DENV-4 | 110.2 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 | DENV-4 | 143.3 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 | DENV-1 | 470.5 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 | DENV-3 | 250.8 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30 | DENV-2 | 1992.7 Titer |
Primary
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365
GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.
Time frame: Day 365
Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 | DENV-1 | 247.3 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 | DENV-2 | 1726.0 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 | DENV-3 | 163.2 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 | DENV-4 | 75.3 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 | DENV-4 | 77.0 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 | DENV-1 | 264.1 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 | DENV-3 | 132.6 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365 | DENV-2 | 809.5 Titer |
Primary
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90
GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.
Time frame: Day 90
Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 | DENV-1 | 376.5 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 | DENV-2 | 4090.2 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 | DENV-3 | 266.5 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 | DENV-4 | 85.6 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 | DENV-4 | 117.4 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 | DENV-1 | 394.0 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 | DENV-3 | 218.0 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90 | DENV-2 | 1647.3 Titer |
Primary
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Time frame: Day 15
Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 | DENV-1 | 70.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 | DENV-2 | 74.1 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 | DENV-3 | 68.8 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 | DENV-4 | 57.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 | DENV-4 | 60.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 | DENV-1 | 72.4 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 | DENV-3 | 62.4 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15 | DENV-2 | 65.9 percentage of participants |
Primary
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Time frame: Day 180
Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 | DENV-1 | 93.4 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 | DENV-3 | 88.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 | DENV-2 | 98.2 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 | DENV-4 | 78.9 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 | DENV-2 | 92.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 | DENV-1 | 89.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 | DENV-4 | 84.0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180 | DENV-3 | 82.2 percentage of participants |
Primary
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Time frame: Day 30
Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 | DENV-1 | 97.1 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 | DENV-2 | 98.8 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 | DENV-3 | 89.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 | DENV-4 | 78.0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 | DENV-4 | 87.2 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 | DENV-1 | 91.3 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 | DENV-3 | 83.7 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30 | DENV-2 | 89.5 percentage of participants |
Primary
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Time frame: Day 365
Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 | DENV-1 | 84.4 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 | DENV-2 | 98.8 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 | DENV-3 | 79.4 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 | DENV-4 | 72.5 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 | DENV-4 | 81.4 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 | DENV-1 | 89.7 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 | DENV-3 | 77.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365 | DENV-2 | 91.0 percentage of participants |
Primary
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Time frame: Day 90
Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 | DENV-1 | 89.3 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 | DENV-2 | 99.4 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 | DENV-3 | 85.8 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 | DENV-4 | 76.9 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 | DENV-4 | 86.4 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 | DENV-1 | 89.5 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 | DENV-3 | 86.4 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90 | DENV-2 | 92.6 percentage of participants |
Secondary
Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination
The duration of vaccine viremia for each vaccine strain was defined as the date when vaccine viremia was last detected (positive result) to date when vaccine viremia was first detected (positive result) + 1 day. It was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay.
Time frame: Days 5, 7, 9, 11, 15, 17, 21 and 30
Population: Participants from the safety analysis set, all randomized participants who received at least 1 dose of study vaccine. Here 'number analyzed' refers to participants with a positive vaccine viremia test result.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | TDV-2 | 5.0 days |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | TDV-3 | 1.0 days |
| Tetravalent Dengue Vaccine (TDV) | Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | TDV-2 | 4.0 days |
| Tetravalent Dengue Vaccine (TDV) | Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | TDV-3 | 1.0 days |
| Tetravalent Dengue Vaccine (TDV) | Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | TDV-4 | 1.0 days |
| Unknown | Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | TDV-1 | — days |
Secondary
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status
Baseline dengue seropositivity was based on the microneutralization test (MNT) result and was defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. The four DENV serotypes are DENV-1, DENV-2, DENV-3, and DENV-4.
Time frame: Days 15, 30, 90, 180 and 365
Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-3 (Seropositive) | 677.7 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-1 (Seronegative) | 46.1 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-3 (Seropositive) | 1940.7 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-2 (Seronegative) | 2941.4 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-2 (Seronegative) | 15.0 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-3 (Seronegative) | 36.7 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-4 (Seropositive) | 492.8 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-4 (Seronegative) | 16.5 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-2 (Seropositive) | 1603.0 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-1 (Seropositive) | 2327.2 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-1 (Seronegative) | 122.0 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-2 (Seropositive) | 4412.0 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-3 (Seronegative) | 14.5 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-3 (Seropositive) | 1248.3 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-2 (Seronegative) | 10965.9 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-4 (Seropositive) | 399.5 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-4 (Seropositive) | 181.8 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-1 (Seronegative) | 46.6 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-3 (Seronegative) | 65.9 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-2 (Seronegative) | 1394.1 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-4 (Seronegative) | 7.5 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-3 (Seronegative) | 34.5 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-4 (Seronegative) | 20.9 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-4 (Seronegative) | 16.4 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-1 (Seropositive) | 1256.2 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-1 (Seropositive) | 1633.3 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-1 (Seropositive) | 2486.8 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-2 (Seropositive) | 3316.0 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-1 (Seropositive) | 4058.9 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-3 (Seropositive) | 830.6 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-2 (Seropositive) | 5501.1 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-4 (Seropositive) | 346.3 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-1 (Seronegative) | 14.2 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-1 (Seronegative) | 30.7 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-3 (Seropositive) | 1582.8 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-2 (Seronegative) | 838.7 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-3 (Seronegative) | 27.0 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-2 (Seropositive) | 6970.3 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-4 (Seronegative) | 13.9 Titer |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-4 (Seropositive) | 375.6 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-1 (Seropositive) | 1356.2 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-1 (Seropositive) | 675.2 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-2 (Seropositive) | 1057.4 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-3 (Seropositive) | 376.0 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-4 (Seropositive) | 110.6 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-1 (Seronegative) | 12.3 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-2 (Seronegative) | 8.3 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-3 (Seronegative) | 8.9 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-4 (Seronegative) | 8.1 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-1 (Seropositive) | 1763.7 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-2 (Seropositive) | 4193.3 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-3 (Seropositive) | 1015.7 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-4 (Seropositive) | 304.7 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-1 (Seronegative) | 95.7 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-2 (Seronegative) | 812.9 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-3 (Seronegative) | 46.5 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-4 (Seronegative) | 57.7 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-1 (Seropositive) | 1714.5 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-2 (Seropositive) | 3601.4 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-3 (Seropositive) | 925.6 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-4 (Seropositive) | 303.8 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-1 (Seronegative) | 71.6 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-2 (Seronegative) | 664.9 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-3 (Seronegative) | 40.7 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-4 (Seronegative) | 39.0 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-2 (Seronegative) | 247.6 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-2 (Seropositive) | 2952.0 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-3 (Seropositive) | 693.6 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-4 (Seropositive) | 268.3 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-1 (Seronegative) | 55.7 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-2 (Seronegative) | 444.3 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-3 (Seronegative) | 29.0 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-4 (Seronegative) | 26.8 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-1 (Seropositive) | 1081.5 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-2 (Seropositive) | 2177.3 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-3 (Seropositive) | 600.2 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-4 (Seropositive) | 212.6 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-1 (Seronegative) | 48.8 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-3 (Seronegative) | 21.7 Titer |
| Tetravalent Dengue Vaccine (TDV) | Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-4 (Seronegative) | 22.9 Titer |
Secondary
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination
Vaccine Viremia was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay.
Time frame: Days 5, 7, 9, 11, 15, 17, 21 and 30
Population: Participants from the safety analysis set, all randomized participants who received at least 1 dose of study vaccine. Here 'number analyzed' refers to participants with a positive vaccine viremia test result.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-2 | 3.60 log10 [genome equivalents per mL] | Standard Deviation 0.32 |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-2 | 3.63 log10 [genome equivalents per mL] | Standard Deviation 0.494 |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-3 | 2.81 log10 [genome equivalents per mL] | — |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 11, TDV-2 | 3.64 log10 [genome equivalents per mL] | Standard Deviation 0.458 |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 17, TDV-2 | 3.53 log10 [genome equivalents per mL] | Standard Deviation 0.336 |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 7, TDV-3 | 2.82 log10 [genome equivalents per mL] | — |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 21, TDV-2 | 3.57 log10 [genome equivalents per mL] | — |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-3 | 2.71 log10 [genome equivalents per mL] | — |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 7, TDV-2 | 3.73 log10 [genome equivalents per mL] | Standard Deviation 0.631 |
| Tetravalent Dengue Vaccine (TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 21, TDV-2 | 3.41 log10 [genome equivalents per mL] | Standard Deviation 0.426 |
| Tetravalent Dengue Vaccine (TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 30, TDV-2 | 3.22 log10 [genome equivalents per mL] | — |
| Tetravalent Dengue Vaccine (TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 7, TDV-2 | 3.78 log10 [genome equivalents per mL] | Standard Deviation 0.446 |
| Tetravalent Dengue Vaccine (TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-2 | 3.63 log10 [genome equivalents per mL] | Standard Deviation 0.711 |
| Tetravalent Dengue Vaccine (TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-3 | 2.67 log10 [genome equivalents per mL] | Standard Deviation 0.019 |
| Tetravalent Dengue Vaccine (TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 11, TDV-2 | 3.66 log10 [genome equivalents per mL] | Standard Deviation 0.481 |
| Tetravalent Dengue Vaccine (TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 11, TDV-3 | 2.89 log10 [genome equivalents per mL] | — |
| Tetravalent Dengue Vaccine (TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-2 | 3.54 log10 [genome equivalents per mL] | Standard Deviation 0.348 |
| Tetravalent Dengue Vaccine (TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-4 | 3.76 log10 [genome equivalents per mL] | — |
| Tetravalent Dengue Vaccine (TDV) | Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 17, TDV-2 | 3.44 log10 [genome equivalents per mL] | Standard Deviation 0.332 |
Secondary
Number of Participants With at Least One Unsolicited Adverse Events (AEs) Following Vaccination
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a study vaccine; it does not necessarily have to have a causal relationship with study vaccine administration.
Time frame: Within 28 days after Vaccination
Population: The safety set included all randomized participants who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With at Least One Unsolicited Adverse Events (AEs) Following Vaccination | 70 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With at Least One Unsolicited Adverse Events (AEs) Following Vaccination | 78 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose 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 through end of study (Day 365)
Population: The safety set included all randomized participants who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
Secondary
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain \[Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)\], erythema \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\] and swelling \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\].
Time frame: Within 7 days after Vaccination
Population: The safety set included all randomized participants who received the study vaccine. Here 'number analyzed' is the number of participants with data available for analysis. Only categories for which there was at least 1 participant are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Pain, Grade 1 | 77 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Erythema, Grade 1 | 18 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Pain, Grade 3 | 1 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Erythema, Grade 2 | 1 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Pain, Grade 2 | 3 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Swelling, Any Severity | 3 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Erythema, Any Severity | 19 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Swelling, Grade 1 | 3 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Pain, Any Severity | 81 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Swelling, Grade 1 | 4 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Pain, Any Severity | 91 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Pain, Grade 1 | 84 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Pain, Grade 2 | 6 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Pain, Grade 3 | 1 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Erythema, Any Severity | 27 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Erythema, Grade 1 | 21 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Erythema, Grade 2 | 6 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Swelling, Any Severity | 4 Participants |
Secondary
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity
Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, asthenia, malaise and myalgia. Severity grades were: Grade 0: none, Grade 1: mild (no interference with daily activity), Grade 2: moderate (interference with daily activity with or without treatment), Grade 3: severe (prevents normal daily activity with or without treatment). A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination.
Time frame: Within 14 days after Vaccination
Population: The safety set included all randomized participants who received the study vaccine. Here 'number analyzed' is the number of participants with data available for analysis. Only categories for which there was at least 1 participant are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Headache, Any Severity | 50 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Headache, Grade 1 | 33 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Headache, Grade 2 | 14 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Headache, Grade 3 | 3 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Myalgia, Any Severity | 47 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Myalgia, Grade 1 | 38 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Myalgia, Grade 2 | 7 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Myalgia, Grade 3 | 2 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Asthenia, Any Severity | 43 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Asthenia, Grade 1 | 27 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Asthenia, Grade 2 | 15 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Asthenia, Grade 3 | 1 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Malaise, Any Severity | 41 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Malaise, Grade 1 | 26 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Malaise, Grade 2 | 12 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Malaise, Grade 3 | 3 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Fever, Any Severity | 9 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Fever, 38.0-<38.5 (C) | 5 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Fever, 38.5-<39.0 (C) | 2 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Fever, 39.0-<39.5 (C) | 1 Participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Fever, 39.5-<40.0 (C) | 1 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Asthenia, Grade 2 | 15 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Headache, Any Severity | 61 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Fever, 38.5-<39.0 (C) | 4 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Headache, Grade 1 | 40 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Asthenia, Grade 3 | 3 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Headache, Grade 2 | 18 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Fever, Any Severity | 9 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Headache, Grade 3 | 3 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Malaise, Any Severity | 49 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Myalgia, Any Severity | 47 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Fever, 39.5-<40.0 (C) | 0 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Myalgia, Grade 1 | 33 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Malaise, Grade 1 | 32 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Myalgia, Grade 2 | 11 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Fever, 38.0-<38.5 (C) | 3 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Myalgia, Grade 3 | 3 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Malaise, Grade 2 | 12 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Asthenia, Any Severity | 56 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Fever, 39.0-<39.5 (C) | 2 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Asthenia, Grade 1 | 38 Participants |
| Tetravalent Dengue Vaccine (TDV) | Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity | Malaise, Grade 3 | 5 Participants |
Secondary
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination
Vaccine Viremia was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay.
Time frame: Days 5, 7, 9, 11, 15, 17, 21 and 30
Population: Participants from the safety analysis set, all randomized participants who received at least 1 dose of study vaccine, with data available at the given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-1 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 5, TDV-2 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 5, TDV-3 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 5, TDV-4 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 7, TDV-1 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 7, TDV-2 | 16.6 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 7, TDV-3 | 0.6 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 7, TDV-4 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 5, TDV-1 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-2 | 44.6 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-3 | 0.6 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-4 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 11, TDV-1 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 11, TDV-2 | 48.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 11, TDV-3 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 11, TDV-4 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-1 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-2 | 35.5 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-3 | 0.6 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-4 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 17, TDV-1 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 17, TDV-2 | 15.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 17, TDV-3 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 17, TDV-4 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 21, TDV-1 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 21, TDV-2 | 0.6 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 21, TDV-3 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 21, TDV-4 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 30, TDV-1 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 30, TDV-2 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 30, TDV-3 | 0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 30, TDV-4 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 30, TDV-4 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 5, TDV-1 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-1 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 5, TDV-2 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 21, TDV-1 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 5, TDV-3 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-2 | 14.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 5, TDV-4 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 30, TDV-1 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 7, TDV-1 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-3 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 7, TDV-2 | 3.4 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 21, TDV-2 | 1.7 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 7, TDV-3 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 15, TDV-4 | 0.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 7, TDV-4 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 30, TDV-3 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-1 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 17, TDV-1 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-2 | 13.4 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 21, TDV-3 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-3 | 1.2 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 17, TDV-2 | 11.7 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 9, TDV-4 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 30, TDV-2 | 0.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 11, TDV-1 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 17, TDV-3 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 11, TDV-2 | 19.8 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 21, TDV-4 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 11, TDV-3 | 0.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 17, TDV-4 | 0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination | Day 11, TDV-4 | 0 percentage of participants |
Secondary
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status
Baseline dengue seropositivity was based on the MNT result and was defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. Seropositive rate was defined as a reciprocal neutralizing titer ≥ 10. Seropositivity was assessed for the four Dengue serotypes are DENV-1, DENV-2, DENV-3, and DEN-4.
Time frame: Days 15, 30, 90, 180, and 365
Population: The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here 'number analyzed' refers to participants with valid MNT results available at given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-3 (Seropositive) | 96.7 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-1 (Seropositive) | 93.4 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-2 (Seropositive) | 93.4 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-3 (Seropositive) | 91.2 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-4 (Seropositive) | 89.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-1 (Seronegative) | 43.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-2 (Seronegative) | 51.9 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-3 (Seronegative) | 43.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-4 (Seronegative) | 21.5 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-1 (Seropositive) | 100.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-2 (Seropositive) | 98.9 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-4 (Seropositive) | 94.5 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-1 (Seronegative) | 93.9 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-2 (Seronegative) | 98.8 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-3 (Seronegative) | 80.5 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-4 (Seronegative) | 59.8 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-1 (Seropositive) | 98.9 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-2 (Seropositive) | 100.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-3 (Seropositive) | 100.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-4 (Seropositive) | 95.5 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-1 (Seronegative) | 78.8 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-2 (Seronegative) | 98.8 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-3 (Seronegative) | 70.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-4 (Seronegative) | 56.3 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-1 (Seropositive) | 100.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-2 (Seropositive) | 100.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-3 (Seropositive) | 100.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-4 (Seropositive) | 95.5 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-1 (Seronegative) | 85.7 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-2 (Seronegative) | 96.1 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-3 (Seronegative) | 74.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-4 (Seronegative) | 59.7 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-1 (Seropositive) | 97.6 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-2 (Seropositive) | 100.0 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-3 (Seropositive) | 95.2 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-4 (Seropositive) | 95.2 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-1 (Seronegative) | 69.7 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-2 (Seronegative) | 97.4 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-3 (Seronegative) | 61.8 percentage of participants |
| High-dose Tetravalent Dengue Vaccine (HD-TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-4 (Seronegative) | 47.4 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-2 (Seronegative) | 81.7 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-1 (Seronegative) | 77.3 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-1 (Seropositive) | 98.9 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-3 (Seronegative) | 65.3 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-2 (Seropositive) | 95.7 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-2 (Seronegative) | 85.3 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-4 (Seropositive) | 95.3 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-4 (Seropositive) | 91.4 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-3 (Seronegative) | 73.3 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-1 (Seronegative) | 40.3 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-4 (Seronegative) | 69.3 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-2 (Seronegative) | 29.9 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-4 (Seronegative) | 72.0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-3 (Seronegative) | 27.3 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-4 (Seronegative) | 64.8 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-4 (Seronegative) | 23.4 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-1 (Seropositive) | 100.0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-1 (Seropositive) | 100.0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-1 (Seropositive) | 100.0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-2 (Seropositive) | 98.9 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 15, DENV-3 (Seropositive) | 91.4 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-3 (Seropositive) | 95.7 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-2 (Seropositive) | 100.0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-4 (Seropositive) | 96.8 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-1 (Seronegative) | 77.5 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-1 (Seronegative) | 80.8 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-3 (Seropositive) | 96.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-2 (Seronegative) | 78.2 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-2 (Seropositive) | 98.8 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-3 (Seronegative) | 69.2 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-4 (Seropositive) | 96.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 30, DENV-4 (Seronegative) | 75.6 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-3 (Seronegative) | 54.9 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-1 (Seropositive) | 100.0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-1 (Seronegative) | 77.3 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-2 (Seropositive) | 98.9 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 365, DENV-3 (Seropositive) | 96.5 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-3 (Seropositive) | 97.7 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 180, DENV-2 (Seronegative) | 84.0 percentage of participants |
| Tetravalent Dengue Vaccine (TDV) | Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status | Day 90, DENV-4 (Seropositive) | 98.9 percentage of participants |