Dengue Fever
Conditions
Keywords
Vaccine
Brief summary
The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60 years in non-endemic country(ies) for dengue.
Detailed description
The vaccine tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). The primary objective of this trial is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive lots of TDV in healthy participants in non-endemic country(ies) for dengue. The study will enroll approximately 924 healthy participants. Participants will be randomized in 2:2:2:1 to one of 4 trial groups to receive TDV (Lots 1, 2 or 3) or placebo: * TDV 0.5 mL subcutaneous injection OR * Placebo normal saline solution (0.9% NaCl) for injection. In each trial group, all participants will receive 2 doses of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3). Immunogenicity will be assessed in participants included in the immunogenicity subset (TDV groups: 176 participants each and placebo group: 88 participants) and safety will be assessed in all participants in each group. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 270 days. Participants will make multiple visits to the clinic including a final visit at Day 270.
Interventions
BIOLOGICALTAK-003
TDV subcutaneous injection
BIOLOGICALPlacebo
TDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A double-blind study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and the clinical judgment of the Investigator. 2. Signs and dates a written informed consent form 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.
Exclusion criteria
1. Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination. 2. Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccine or placebo). 3. Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome). 4. Known or suspected impairment/alteration of immune function, including: 1. 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 (M0) (use of inhaled, intranasal, or topical corticosteroids is allowed) 2. 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 (M0). 3. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial. 4. Receipt of immunostimulants within 60 days prior to Day 1 (M0). 5. Hepatitis C virus infection. 6. Genetic immunodeficiency. 5. Has abnormalities of splenic or thymic function. 6. Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 7. Has any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). 8. Has body mass index (BMI) greater than or equal to 35 kg/m\^2 (= weight in kg/\[height in meters\^2\]). 9. Has history of substance or alcohol abuse within the past 2 years. 10. Had previous and planned vaccination (during the trial conduct) against any flavivirus including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis. 11. Has a current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile (WN) fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a history of prolonged (≥1 year) habitation in a dengue endemic area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | 1 month post second dose (Day 120) | GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | 6 months post second dose (Day 270) | GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. |
| Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | Within 7 Days of each Vaccination (day of vaccination + 6 days) | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (\<25 mm, mild: \>25 - ≤50 mm, moderate: \>50 - ≤100 mm, severe: \>100 mm) and swelling (edema/induration) (\<25 mm, mild: \>25 - ≤50 mm, moderate: \>50 - ≤100 mm, severe: \>100 mm ). The percentages were rounded off to the first decimal place. |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | Within 14 Days of each Vaccination (day of vaccination + 13 days) | Solicited systemic AEs include fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. Solicited systemic AEs (headache, asthenia, malaise and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it. The percentages were rounded off to the first decimal place. |
| Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | 1 month post second dose (Day 120) and 6 months post second dose (Day 270) | Seropositivity was defined as a reciprocal neutralizing titer ≥ 10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. |
| Percentage of Participants With Serious Adverse Events (SAEs) | From the first vaccination on Day 1 until the end of the trial (Day 270) | An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event that may require intervention to prevent any of the above mentioned criteria and/or may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. The percentages were rounded off to the first decimal place. |
| Percentage of Participants With Medically Attended Adverse Events (MAAEs) | From the first vaccination on Day 1 until the end of the trial (Day 270) | MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria. The percentages were rounded off to the first decimal place. |
| Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination | Within 28 days (day of vaccination + 27 days) after each vaccination | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 14 investigative sites in the United States from 12 February 2018 to 14 January 2019.
Pre-assignment details
Healthy participants were enrolled in 2:2:2:1 ratio into one of the four trial groups and received either Tetravalent Dengue Vaccine (TDV) lot 1, TDV Lot 2, TDV Lot 3 or Placebo for the investigation of lot to lot consistency of three consecutive lots.
Participants by arm
| Arm | Count |
|---|---|
| Placebo TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90. | 132 |
| TDV Lot 1 Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. | 263 |
| TDV Lot 2 Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. | 264 |
| TDV Lot 3 Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. | 264 |
| Total | 923 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 | 1 |
| Overall Study | Death | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 10 | 19 | 17 | 22 |
| Overall Study | Randomized but not vaccinated | 1 | 0 | 2 | 1 |
| Overall Study | Reason not Specified | 2 | 5 | 3 | 1 |
| Overall Study | Withdrawal of consent | 4 | 10 | 4 | 5 |
Baseline characteristics
| Characteristic | TDV Lot 2 | Total | TDV Lot 3 | TDV Lot 1 | Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 11.71 | 41.2 years STANDARD_DEVIATION 12.25 | 40.9 years STANDARD_DEVIATION 12.77 | 40.8 years STANDARD_DEVIATION 12.54 | 40.7 years STANDARD_DEVIATION 11.7 |
| Body Mass Index (BMI) | 27.50 kg/m^2 STANDARD_DEVIATION 4.464 | 27.55 kg/m^2 STANDARD_DEVIATION 4.309 | 27.84 kg/m^2 STANDARD_DEVIATION 4.408 | 27.17 kg/m^2 STANDARD_DEVIATION 4.27 | 27.84 kg/m^2 STANDARD_DEVIATION 3.825 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 70 Participants | 20 Participants | 16 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 239 Participants | 850 Participants | 244 Participants | 247 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Height | 171.6 cm STANDARD_DEVIATION 10.11 | 171.5 cm STANDARD_DEVIATION 9.99 | 171.8 cm STANDARD_DEVIATION 9.86 | 171.0 cm STANDARD_DEVIATION 9.68 | 171.7 cm STANDARD_DEVIATION 10.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 12 Participants | 3 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 56 Participants | 178 Participants | 44 Participants | 55 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 13 Participants | 6 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 202 Participants | 714 Participants | 208 Participants | 200 Participants | 104 Participants |
| Sex: Female, Male Female | 150 Participants | 497 Participants | 134 Participants | 144 Participants | 69 Participants |
| Sex: Female, Male Male | 114 Participants | 426 Participants | 130 Participants | 119 Participants | 63 Participants |
| Weight | 81.31 kg STANDARD_DEVIATION 16.543 | 81.28 kg STANDARD_DEVIATION 15.827 | 82.35 kg STANDARD_DEVIATION 15.928 | 79.63 kg STANDARD_DEVIATION 15.203 | 82.37 kg STANDARD_DEVIATION 15.275 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 131 | 0 / 264 | 0 / 261 | 0 / 263 |
| other Total, other adverse events | 4 / 131 | 16 / 264 | 26 / 261 | 23 / 263 |
| serious Total, serious adverse events | 4 / 131 | 10 / 264 | 3 / 261 | 3 / 263 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset
GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: 1 month post second dose (Day 120)
Population: Per protocol Set (PPS) included all DENV-naïve participants in immunogenicity subset who received at least 1 dose of trial vaccine, with data available for Baseline (Day 1) and at least 1 post-Baseline immunogenicity measurement and had no major protocol violations.Number of participants analyzed:participants with data available at given timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-1 | 5.3 titer |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-2 | 6.3 titer |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-3 | 5.4 titer |
| Placebo | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-4 | 5.4 titer |
| TDV Lot 1 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-2 | 3090.3 titer |
| TDV Lot 1 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-3 | 149.5 titer |
| TDV Lot 1 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-4 | 116.3 titer |
| TDV Lot 1 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-1 | 202.9 titer |
| TDV Lot 2 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-3 | 117.3 titer |
| TDV Lot 2 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-2 | 2386.0 titer |
| TDV Lot 2 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-4 | 187.9 titer |
| TDV Lot 2 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-1 | 293.8 titer |
| TDV Lot 3 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-4 | 115.8 titer |
| TDV Lot 3 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-2 | 3574.1 titer |
| TDV Lot 3 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-1 | 322.1 titer |
| TDV Lot 3 | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | DENV-3 | 122.8 titer |
Comparison: DENV-195% CI: [0.46, 1.04]
Comparison: DENV-195% CI: [0.6, 1.38]
Comparison: DENV-195% CI: [0.41, 0.96]
Comparison: DENV-295% CI: [0.98, 1.71]
Comparison: DENV-295% CI: [0.51, 0.88]
Comparison: DENV-295% CI: [0.65, 1.15]
Comparison: DENV-395% CI: [0.91, 1.78]
Comparison: DENV-395% CI: [0.68, 1.33]
Comparison: DENV-395% CI: [0.87, 1.71]
Comparison: DENV-495% CI: [0.46, 0.82]
Comparison: DENV-495% CI: [1.22, 2.17]
Comparison: DENV-495% CI: [0.75, 1.35]
Secondary
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset
GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: 6 months post second dose (Day 270)
Population: Per protocol Set (PPS) included all DENV-naïve participants in immunogenicity subset who received at least 1 dose of trial vaccine, with data available for Baseline (Day 1) and at least 1 post-Baseline immunogenicity measurement and had no major protocol violations.Number of participants analyzed:participants with data available at given timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-1 | 5.4 titer |
| Placebo | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-2 | 5.8 titer |
| Placebo | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-3 | NA titer |
| Placebo | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-4 | NA titer |
| TDV Lot 1 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-2 | 1507.2 titer |
| TDV Lot 1 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-3 | 88.0 titer |
| TDV Lot 1 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-4 | 64.1 titer |
| TDV Lot 1 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-1 | 122.5 titer |
| TDV Lot 2 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-3 | 63.1 titer |
| TDV Lot 2 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-2 | 1097.5 titer |
| TDV Lot 2 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-4 | 77.5 titer |
| TDV Lot 2 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-1 | 136.7 titer |
| TDV Lot 3 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-4 | 51.2 titer |
| TDV Lot 3 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-2 | 1693.3 titer |
| TDV Lot 3 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-1 | 168.4 titer |
| TDV Lot 3 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | DENV-3 | 71.6 titer |
Comparison: DENV-195% CI: [0.56, 1.42]
Comparison: DENV-195% CI: [0.51, 1.28]
Comparison: DENV-195% CI: [0.46, 1.16]
Comparison: DENV-295% CI: [1.02, 1.86]
Comparison: DENV-295% CI: [0.48, 0.87]
Comparison: DENV-295% CI: [0.66, 1.21]
Comparison: DENV-395% CI: [1, 1.94]
Comparison: DENV-395% CI: [0.64, 1.21]
Comparison: DENV-395% CI: [0.88, 1.71]
Comparison: DENV-495% CI: [0.58, 1.18]
Comparison: DENV-495% CI: [1.07, 2.14]
Comparison: DENV-495% CI: [0.88, 1.78]
Secondary
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset
Seropositivity was defined as a reciprocal neutralizing titer ≥ 10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: 1 month post second dose (Day 120) and 6 months post second dose (Day 270)
Population: PPS included all DENV-naïve participants in the immunogenicity subset who received at least 1 dose of trial vaccine, with data available for Baseline (Day 1) and at least 1 post-Baseline immunogenicity measurement, and who had no major protocol violations. Number analyzed are participants with data available at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-3, Day 270 | 0 percentage of participants |
| Placebo | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-2, Day 270 | 6.8 percentage of participants |
| Placebo | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-1, Day 270 | 3.4 percentage of participants |
| Placebo | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-4, Day 270 | 0 percentage of participants |
| Placebo | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-2, Day 120 | 6.7 percentage of participants |
| Placebo | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-1, Day 120 | 1.7 percentage of participants |
| Placebo | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-3, Day 120 | 1.7 percentage of participants |
| Placebo | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-4, Day 120 | 1.7 percentage of participants |
| TDV Lot 1 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-2, Day 270 | 100.0 percentage of participants |
| TDV Lot 1 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-3, Day 270 | 95.5 percentage of participants |
| TDV Lot 1 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-4, Day 120 | 97.5 percentage of participants |
| TDV Lot 1 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-1, Day 270 | 97.3 percentage of participants |
| TDV Lot 1 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-3, Day 120 | 97.5 percentage of participants |
| TDV Lot 1 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-4, Day 270 | 92.8 percentage of participants |
| TDV Lot 1 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-1, Day 120 | 97.5 percentage of participants |
| TDV Lot 1 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-2, Day 120 | 99.2 percentage of participants |
| TDV Lot 2 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-4, Day 120 | 100.0 percentage of participants |
| TDV Lot 2 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-1, Day 120 | 96.9 percentage of participants |
| TDV Lot 2 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-2, Day 120 | 98.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-3, Day 120 | 94.6 percentage of participants |
| TDV Lot 2 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-1, Day 270 | 89.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-2, Day 270 | 97.6 percentage of participants |
| TDV Lot 2 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-3, Day 270 | 88.7 percentage of participants |
| TDV Lot 2 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-4, Day 270 | 94.3 percentage of participants |
| TDV Lot 3 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-1, Day 120 | 99.2 percentage of participants |
| TDV Lot 3 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-2, Day 270 | 99.2 percentage of participants |
| TDV Lot 3 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-2, Day 120 | 100.0 percentage of participants |
| TDV Lot 3 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-4, Day 270 | 91.7 percentage of participants |
| TDV Lot 3 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-3, Day 270 | 92.5 percentage of participants |
| TDV Lot 3 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-1, Day 270 | 95.8 percentage of participants |
| TDV Lot 3 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-4, Day 120 | 97.5 percentage of participants |
| TDV Lot 3 | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | DENV-3, Day 120 | 98.3 percentage of participants |
Comparison: DENV-1 at Day 12095% CI: [-4.99, 6.06]
Comparison: DENV-1 at Day 12095% CI: [-6.9, 3.19]
Comparison: DENV-1 at Day 12095% CI: [-7.45, 2.69]
Comparison: DENV-1 at Day 27095% CI: [0.64, 15.3]
Comparison: DENV-1 at Day 27095% CI: [-4.67, 7.65]
Comparison: DENV-1 at Day 27095% CI: [-14, 1.04]
Comparison: DENV-2 at Day 12095% CI: [-3.87, 5.29]
Comparison: DENV-2 at Day 12095% CI: [-5.24, 3.17]
Comparison: DENV-2 at Day 12095% CI: [-6.05, 2.58]
Comparison: DENV-2 at Day 27095% CI: [-2.12, 7.44]
Comparison: DENV-2 at Day 27095% CI: [-3.41, 5.24]
Comparison: DENV-2 at Day 27095% CI: [-6.67, 3.17]
Comparison: DENV-3 at Day 12095% CI: [-3.07, 9.06]
Comparison: DENV-3 at Day 12095% CI: [-6.17, 4.44]
Comparison: DENV-3 at Day 12095% CI: [-9.74, 2.03]
Comparison: DENV-3 at Day 27095% CI: [-1.03, 14.56]
Comparison: DENV-3 at Day 27095% CI: [-4.28, 10.23]
Comparison: DENV-3 at Day 27095% CI: [-11.97, 4.39]
Comparison: DENV-4 at Day 12095% CI: [-7.68, 1.55]
Comparison: DENV-4 at Day 12095% CI: [-5.47, 5.62]
Comparison: DENV-4 at Day 12095% CI: [-1.52, 7.81]
Comparison: DENV-4 at Day 27095% CI: [-9.14, 5.69]
Comparison: DENV-4 at Day 27095% CI: [-6.9, 8.95]
Comparison: DENV-4 at Day 27095% CI: [-4.68, 10.18]
Secondary
Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
Time frame: Within 28 days (day of vaccination + 27 days) after each vaccination
Population: Safety Set included all participants who received at least 1 dose of trial vaccine (TDV or placebo). Participants were analyzed as treated. Number analyzed is the number of participants with data available for the specific category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination | After First Vaccination | 13.7 percentage of participants |
| Placebo | Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination | After Second Vaccination | 7.8 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination | After Second Vaccination | 10.5 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination | After First Vaccination | 18.6 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination | After First Vaccination | 18.0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination | After Second Vaccination | 7.7 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination | After First Vaccination | 16.7 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination | After Second Vaccination | 6.6 percentage of participants |
Secondary
Percentage of Participants With Medically Attended Adverse Events (MAAEs)
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria. The percentages were rounded off to the first decimal place.
Time frame: From the first vaccination on Day 1 until the end of the trial (Day 270)
Population: Safety Set included all participants who received at least 1 dose of trial vaccine (TDV or placebo). Participants were analyzed as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Medically Attended Adverse Events (MAAEs) | 13.7 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Medically Attended Adverse Events (MAAEs) | 17.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Medically Attended Adverse Events (MAAEs) | 12.3 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Medically Attended Adverse Events (MAAEs) | 11.8 percentage of participants |
Secondary
Percentage of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event that may require intervention to prevent any of the above mentioned criteria and/or may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. The percentages were rounded off to the first decimal place.
Time frame: From the first vaccination on Day 1 until the end of the trial (Day 270)
Population: Safety Set included all participants who received at least 1 dose of trial vaccine (TDV or placebo). Participants were analyzed as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) | 3.1 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Serious Adverse Events (SAEs) | 3.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Serious Adverse Events (SAEs) | 1.1 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Serious Adverse Events (SAEs) | 1.1 percentage of participants |
Secondary
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (\<25 mm, mild: \>25 - ≤50 mm, moderate: \>50 - ≤100 mm, severe: \>100 mm) and swelling (edema/induration) (\<25 mm, mild: \>25 - ≤50 mm, moderate: \>50 - ≤100 mm, severe: \>100 mm ). The percentages were rounded off to the first decimal place.
Time frame: Within 7 Days of each Vaccination (day of vaccination + 6 days)
Population: Safety Set included all participants who received at least 1 dose of trial vaccine (TDV or placebo). Participants were analyzed as treated. Number analyzed are participants with data available for the specific category. Only categories with at least one participant are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Local AE-Any | 13.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Missing Severity | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1,Erythema-Moderate: >5-<=10(cm) | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Mild: 2.5-5(cm) | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1,Swelling-Moderate: >5-<=10(cm) | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Mild: 2.5-5(cm) | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Missing Severity | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Swelling-Any Severity | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Any Severity | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Mild | 15.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Missing Severity | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Missing Severity | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Moderate: >5-<=10(cm) | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Moderate | 1.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Mild: 2.5-5(cm) | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Erythema-Any Severity | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Moderate: >5-<=10(cm) | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Moderate | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Any Severity | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Any Severity | 16.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Mild | 13.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Any Severity | 13.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Mild: 2.5-5(cm) | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Any Local AE | 17.5 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Moderate | 5.5 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Any Local AE | 51.0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Any Severity | 45.5 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Mild | 39.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Severe | 0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Any Severity | 25.7 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Mild: 2.5-5(cm) | 23.7 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1,Erythema-Moderate: >5-<=10(cm) | 1.2 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Missing Severity | 0.8 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Any Severity | 7.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Mild: 2.5-5(cm) | 7.1 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1,Swelling-Moderate: >5-<=10(cm) | 0.4 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Missing Severity | 0.4 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Local AE-Any | 37.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Any Severity | 32.8 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Mild | 27.6 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Moderate | 3.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Severe | 1.3 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Erythema-Any Severity | 19.0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Mild: 2.5-5(cm) | 18.1 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Moderate: >5-<=10(cm) | 0.4 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Missing Severity | 0.4 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Swelling-Any Severity | 6.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Mild: 2.5-5(cm) | 6.5 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Moderate: >5-<=10(cm) | 0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Missing Severity | 0.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Mild: 2.5-5(cm) | 18.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Local AE-Any | 42.1 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Any Severity | 40.6 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Any Severity | 34.6 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Any Severity | 20.3 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Mild | 30.0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Mild: 2.5-5(cm) | 4.2 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Moderate | 3.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Severe | 0.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Severe | 0.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Erythema-Any Severity | 18.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Moderate | 5.1 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Missing Severity | 0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Mild: 2.5-5(cm) | 17.1 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Moderate: >5-<=10(cm) | 0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Moderate: >5-<=10(cm) | 1.7 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Mild | 34.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Missing Severity | 0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Missing Severity | 0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Any Severity | 5.5 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Mild: 2.5-5(cm) | 5.1 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1,Erythema-Moderate: >5-<=10(cm) | 2.0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Any Local AE | 48.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1,Swelling-Moderate: >5-<=10(cm) | 0.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Swelling-Any Severity | 4.2 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Missing Severity | 0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Any Severity | 6.3 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Swelling-Any Severity | 4.7 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Mild: 2.5-5(cm) | 13.1 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Local AE-Any | 37.1 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Any Severity | 23.0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Mild | 37.7 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1,Erythema-Moderate: >5-<=10(cm) | 0.8 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Any Severity | 30.9 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Any Severity | 41.7 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Missing Severity | 0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Moderate: >5-<=10(cm) | 1.3 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Mild | 28.4 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Severe | 0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Missing Severity | 0.8 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Moderate: >5-<=10(cm) | 0.4 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Moderate | 2.5 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Swelling-Mild: 2.5-5(cm) | 5.6 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Swelling-Mild: 2.5-5(cm) | 4.2 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Missing Severity | 0.4 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Pain-Severe | 0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Pain-Moderate | 4.0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Any Local AE | 50.0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1,Swelling-Moderate: >5-<=10(cm) | 0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Erythema-Any Severity | 14.3 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2,Erythema-Missing Severity | 0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Erythema-Mild: 2.5-5(cm) | 21.8 percentage of participants |
Secondary
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
Solicited systemic AEs include fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. Solicited systemic AEs (headache, asthenia, malaise and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it. The percentages were rounded off to the first decimal place.
Time frame: Within 14 Days of each Vaccination (day of vaccination + 13 days)
Population: Safety Set included all participants who received at least 1 dose of trial vaccine (TDV or placebo). Participants were analyzed as treated. Number analyzed are participants with data available for the specific category. Only categories with at least one participant are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Systemic AEs-Any | 23.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Moderate | 2.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Mild | 7.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Mild | 5.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Severe | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Mild | 15.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Any Severity | 15.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Any Severity | 7.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-39.0-<39.5 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Moderate | 2.6 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Mild | 13.3 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Moderate | 1.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Moderate | 4.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-38.0-<38.5 | 1.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Moderate | 2.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Moderate | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Mild | 5.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Systemic AEs-Any | 34.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Any Severity | 9.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Severe | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-Any Severity | 1.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Mild | 7.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Any Severity | 22.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Any Severity | 7.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-38.0-<38.5 | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-Any Severity | 1.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Severe | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Any Severity | 12.4 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-38.5-<39.0 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Any Severity | 8.7 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Mild | 17.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Severe | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-39.0-<39.5 | 0.8 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Any Severity | 19.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-39.5-<40.0 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Mild | 9.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-≥41.0 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Moderate | 3.5 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-38.5-<39.0 | 0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Moderate | 2.6 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Mild | 21.3 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Systemic AEs-Any | 26.7 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Mild | 7.3 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Any Severity | 18.1 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Any Severity | 13.1 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Mild | 15.1 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Any Severity | 11.6 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Moderate | 3.0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-38.0-<38.5 | 0.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Severe | 0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Severe | 0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Any Severity | 9.1 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Mild | 7.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Mild | 6.0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Any Severity | 28.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Moderate | 3.0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Moderate | 3.6 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-Any Severity | 0.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Severe | 1.6 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-39.0-<39.5 | 0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Any Severity | 15.5 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Severe | 0.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Mild | 7.1 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Moderate | 6.3 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Systemic AEs-Any | 43.3 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Moderate | 3.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Severe | 2.0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Any Severity | 26.5 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Mild | 19.0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Mild | 12.1 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Moderate | 7.1 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Moderate | 5.9 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Severe | 0.4 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-39.5-<40.0 | 0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Any Severity | 16.8 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-Any Severity | 0.8 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-38.5-<39.0 | 0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-38.0-<38.5 | 0.4 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Severe | 0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-38.5-<39.0 | 0.4 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Severe | 1.6 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-39.0-<39.5 | 0 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Moderate | 4.3 percentage of participants |
| TDV Lot 1 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-≥41.0 | 0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Mild | 7.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Systemic AEs-Any | 39.5 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Any Severity | 27.0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Mild | 19.9 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Moderate | 5.5 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Severe | 1.6 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Any Severity | 15.2 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Mild | 9.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Moderate | 4.3 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Severe | 1.6 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Any Severity | 14.5 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Severe | 2.0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Moderate | 4.7 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Any Severity | 25.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Mild | 16.0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Moderate | 7.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Severe | 1.6 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-Any Severity | 2.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-38.0-<38.5 | 0.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-38.5-<39.0 | 0.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-39.0-<39.5 | 0.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-≥41.0 | 0.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Systemic AEs-Any | 29.2 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Any Severity | 22.5 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Mild | 15.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Moderate | 5.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Severe | 1.3 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Any Severity | 8.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Mild | 6.3 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Moderate | 2.1 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Severe | 0.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Any Severity | 11.3 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Mild | 7.5 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Moderate | 3.3 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Severe | 0.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Any Severity | 14.6 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Mild | 10.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Moderate | 3.3 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Severe | 0.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-Any Severity | 0.8 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-38.0-<38.5 | 0.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-38.5-<39.0 | 0.4 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-39.0-<39.5 | 0 percentage of participants |
| TDV Lot 2 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-39.5-<40.0 | 0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-≥41.0 | 0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-39.0-<39.5 | 0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Moderate | 6.0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Moderate | 2.1 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-38.5-<39.0 | 0.8 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-38.0-<38.5 | 1.2 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Severe | 1.6 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Severe | 0.9 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Fever-Any Severity | 2.0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Severe | 0.4 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-38.5-<39.0 | 0.4 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Any Severity | 14.9 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Moderate | 7.5 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Mild | 14.3 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Mild | 21.4 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Mild | 11.9 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Myalgia-Any Severity | 22.2 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Moderate | 5.6 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Any Severity | 28.6 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Moderate | 2.6 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Mild | 8.3 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Malaise-Any Severity | 15.5 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-39.5-<40.0 | 0.4 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Myalgia-Severe | 0.4 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Severe | 0.8 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Moderate | 4.8 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-39.0-<39.5 | 0.4 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-Any Severity | 2.1 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Mild | 6.3 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Mild | 3.4 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Asthenia-Any Severity | 11.9 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Moderate | 2.1 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Any Severity | 6.0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Severe | 0.8 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Systemic AEs-Any | 42.9 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Asthenia-Severe | 0.4 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Moderate | 4.2 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Mild | 13.6 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Fever-38.0-<38.5 | 0.9 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Any Severity | 7.7 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Headache-Any Severity | 18.6 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Systemic AEs-Any | 28.0 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 1, Headache-Severe | 1.2 percentage of participants |
| TDV Lot 3 | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | After Vaccination 2, Malaise-Mild | 4.7 percentage of participants |