Healthy
Conditions
Keywords
safety and immunogenicity of dengue vaccine
Brief summary
A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine. Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline \[during the screening period or on day of vaccination (Day 0)\], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline \[during the screening period or on day of vaccination (Day 0)\], then on Days 30, 90 and 120. The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).
Interventions
TDV subcutaneous injection
BIOLOGICALTDV New Formulation
TDV New Formulation subcutaneous injection
DRUGPlacebo
Placebo subcutaneous injection
DRUGNew Formulation Placebo
New Formulation placebo subcutaneous injection
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female at least 18 years and ≤ 45 years old at time of screening 2. In good health as determined by medical history, physical examination including height and weight 3. Normal clinical safety laboratory examinations \[Sodium (Na), Potassium (K), Glucose, Blood Urea Nitrogen (BUN), creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin, White Blood Cell (WBC), neutrophil count, hemoglobin, platelets, Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and urinalysis (by dipstick)\]. 4. Weight: Body Mass Index (BMI) ≤32 5. Blood tests negative for antibodies to Human Immuno-virus (HIV-1), Hepatitis C, and Hepatitis B surface antigen
Exclusion criteria
1. Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator 2. Clinically significant ECG findings 3. History of any significant dermatologic disease in the last 6 months, 4. History of diabetes mellitus 5. History of recurring headaches or migraines (more frequent than once per week) or on prescription medication for treatment of recurring headaches or migraines 6. Hypersensitivity to any vaccine 7. Receipt of any vaccine in the 4 weeks preceding the first vaccination 8. Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study 9. Known history of Japanese Encephalitis Virus (JEV) and/or Yellow Fever (YF) 10. Previous vaccination (in a clinical trial or with an approved product) against flaviviruses including dengue, yellow fever (YF) and Japanese Encephalitis (JE) 11. Seropositivity to dengue or West Nile (WN) virus 12. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months 13. Use within the previous 6 months of systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or within the last 3 months. Note, inhaled prednisone (or equivalent) is allowed 14. Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination 15. Use of any prescription or over the counter medications (besides those specifically mentioned above or those required for medical management of concurrent diseases) 7 days before the first vaccination (Day 0) 16. Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids 17. Donation of blood 6 weeks before the first dose(s) (Day 0) until 30 days after the dose on day 90 18. Females who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Day 0 to Day 104 | Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported. |
| Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose | For 30 days after each dose (Up to Day 120) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. |
| Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose | For 30 days after each dose (Up to Day 120) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination. |
| Rate of Seroconversion to Each of Four Dengue Serotypes | Up to 30 days after the last immunization (Up to Day 120) | Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | various timepoints up to 30 days after each dose (Up to Day 120) | Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported. |
| Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Days 30, 90 and 120 after 1st vaccination | — |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 3 investigative sites in the United States from 23 January 2012 to 10 January 2014.
Pre-assignment details
Participants were enrolled in 1 of 6 treatment groups (GRP). GRP1: 1 dose TDV on Day 0 and 90, GRP2: 2 doses of TDV on Day 0, GRP3: 2 Doses of TDV on Day 0 and 1 dose of TDV on Day 90, GRP4: 1 Dose of TDV New Formula on Day 0 and 90, GRP5: 2 doses of TDV New Formula on Day 0 and 90 and GRP6: 1/10 dose of TDV on Day 0 and 90.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (D0:TDV,P D90:TDV) Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90). | 25 |
| Group 2 (DO:TDV,TDV D90:P) TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90. | 25 |
| Group 3 (D0:TDV,TDV D90:TDV) TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90. | 24 |
| Group 4 (D0:TDVN,P D90:TDVN,P) TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. | 21 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. | 21 |
| Group 6 (D0:1/10TDV D90:1/10TDV) 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90. | 24 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Sponsor/Investigator Decision | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal of Consent | 0 | 0 | 0 | 2 | 3 | 0 |
Baseline characteristics
| Characteristic | Group 2 (DO:TDV,TDV D90:P) | Group 1 (D0:TDV,P D90:TDV) | Group 3 (D0:TDV,TDV D90:TDV) | Group 4 (D0:TDVN,P D90:TDVN,P) | Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Group 6 (D0:1/10TDV D90:1/10TDV) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 28.2 years STANDARD_DEVIATION 6.36 | 29.6 years STANDARD_DEVIATION 5.74 | 29.2 years STANDARD_DEVIATION 6.4 | 30.0 years STANDARD_DEVIATION 6.67 | 30.3 years STANDARD_DEVIATION 7.95 | 32.5 years STANDARD_DEVIATION 6.04 | 30.0 years STANDARD_DEVIATION 6.54 |
| Body Mass Index (BMI) | 25.97 kg/m^2 STANDARD_DEVIATION 3.314 | 24.81 kg/m^2 STANDARD_DEVIATION 2.423 | 26.50 kg/m^2 STANDARD_DEVIATION 3.735 | 26.09 kg/m^2 STANDARD_DEVIATION 3.202 | 25.81 kg/m^2 STANDARD_DEVIATION 3.712 | 26.35 kg/m^2 STANDARD_DEVIATION 3.517 | 25.91 kg/m^2 STANDARD_DEVIATION 3.323 |
| Height | 1.71 m STANDARD_DEVIATION 0.084 | 1.71 m STANDARD_DEVIATION 0.092 | 1.70 m STANDARD_DEVIATION 0.108 | 1.76 m STANDARD_DEVIATION 0.105 | 1.73 m STANDARD_DEVIATION 0.099 | 1.75 m STANDARD_DEVIATION 0.104 | 1.72 m STANDARD_DEVIATION 0.1 |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Black/African American | 2 participants | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Hawaiian/Pacific Islander | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic Or Latino | 3 participants | 6 participants | 7 participants | 0 participants | 2 participants | 0 participants | 18 participants |
| Race/Ethnicity, Customized Other | 0 participants | 2 participants | 1 participants | 0 participants | 0 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized White | 19 participants | 17 participants | 14 participants | 20 participants | 19 participants | 23 participants | 112 participants |
| Region of Enrollment United States | 25 participants | 25 participants | 24 participants | 21 participants | 21 participants | 24 participants | 140 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 12 Participants | 8 Participants | 9 Participants | 9 Participants | 67 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 12 Participants | 13 Participants | 12 Participants | 15 Participants | 73 Participants |
| Weight | 75.9 kg STANDARD_DEVIATION 13.22 | 73.3 kg STANDARD_DEVIATION 11.66 | 76.7 kg STANDARD_DEVIATION 15.76 | 80.8 kg STANDARD_DEVIATION 14.12 | 77.3 kg STANDARD_DEVIATION 14.91 | 81.7 kg STANDARD_DEVIATION 16.02 | 77.5 kg STANDARD_DEVIATION 14.36 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 24 / 25 | 18 / 25 | 20 / 24 | 16 / 21 | 17 / 21 | 18 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 24 | 0 / 21 | 0 / 21 | 0 / 24 |
Outcome results
Primary
Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Time frame: For 30 days after each dose (Up to Day 120)
Population: Safety Population included all enrolled participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (D0:TDV,P D90:TDV) | Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose | 22 participants |
| Group 2 (D0:TDV,TDV D90:P) | Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose | 19 participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose | 21 participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose | 17 participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose | 17 participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose | 18 participants |
Primary
Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.
Time frame: For 30 days after each dose (Up to Day 120)
Population: Safety Population included all enrolled participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 (D0:TDV,P D90:TDV) | Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose | 20 participants |
| Group 2 (D0:TDV,TDV D90:P) | Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose | 16 participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose | 18 participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose | 14 participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose | 12 participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose | 14 participants |
Primary
Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported
Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.
Time frame: Day 0 to Day 104
Population: Safety population included all enrolled participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (D0:TDV,P D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Edema=0 | 25 participants |
| Group 1 (D0:TDV,P D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=0 | 19 participants |
| Group 1 (D0:TDV,P D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Erythema=0 | 25 participants |
| Group 1 (D0:TDV,P D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=2 | 0 participants |
| Group 1 (D0:TDV,P D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=0 | 24 participants |
| Group 1 (D0:TDV,P D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=1 | 6 participants |
| Group 1 (D0:TDV,P D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=1 | 1 participants |
| Group 2 (D0:TDV,TDV D90:P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Erythema=0 | 25 participants |
| Group 2 (D0:TDV,TDV D90:P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=1 | 6 participants |
| Group 2 (D0:TDV,TDV D90:P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=0 | 19 participants |
| Group 2 (D0:TDV,TDV D90:P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=0 | 18 participants |
| Group 2 (D0:TDV,TDV D90:P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Edema=0 | 25 participants |
| Group 2 (D0:TDV,TDV D90:P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=2 | 0 participants |
| Group 2 (D0:TDV,TDV D90:P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=1 | 7 participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=0 | 23 participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Erythema=0 | 24 participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Edema=0 | 24 participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=0 | 19 participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=1 | 4 participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=1 | 1 participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=2 | 1 participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=1 | 1 participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Edema=0 | 21 participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Erythema=0 | 21 participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=0 | 20 participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=0 | 16 participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=1 | 5 participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=2 | 0 participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=0 | 21 participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Erythema=0 | 21 participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=2 | 1 participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Edema=0 | 21 participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=1 | 2 participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=1 | 0 participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=0 | 18 participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=2 | 0 participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=0 | 20 participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=0 | 22 participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Erythema=0 | 24 participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Pain=1 | 4 participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Edema=0 | 24 participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Itching=1 | 2 participants |
Primary
Rate of Seroconversion to Each of Four Dengue Serotypes
Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.
Time frame: Up to 30 days after the last immunization (Up to Day 120)
Population: Participants from the Full Analysis Set, all enrolled participants, with data available at the given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 90 (n=25, 24, 23, 20, 18, 24) | 80.0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 120 (n=25, 24, 23, 19, 17, 24) | 60.0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 120 (n=25, 24, 23, 19, 17, 24) | 100.0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 90 (n=25, 24, 23, 20, 18, 24) | 24.0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 30 (n=25, 24, 24, 21, 19, 24) | 100.0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 30 (n=25, 24, 24, 21, 19, 24) | 84.0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 30 (n=25, 24, 24, 21, 19, 24) | 96.0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 30 (n=25, 24, 24, 21, 19, 24) | 36.0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 120 (n=25, 24, 23, 19, 17, 24) | 100.0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 90 (n=25, 24, 23, 20, 18, 24) | 96.0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 120 (n=25, 24, 23, 19, 17, 24) | 100.0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 90 (n=25, 24, 23, 20, 18, 24) | 100.0 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 120 (n=25, 24, 23, 19, 17, 24) | 33.3 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 90 (n=25, 24, 23, 20, 18, 24) | 91.7 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 90 (n=25, 24, 23, 20, 18, 24) | 100.0 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 90 (n=25, 24, 23, 20, 18, 24) | 91.7 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 30 (n=25, 24, 24, 21, 19, 24) | 58.3 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 120 (n=25, 24, 23, 19, 17, 24) | 95.8 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 30 (n=25, 24, 24, 21, 19, 24) | 100.0 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 90 (n=25, 24, 23, 20, 18, 24) | 29.2 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 120 (n=25, 24, 23, 19, 17, 24) | 100.0 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 30 (n=25, 24, 24, 21, 19, 24) | 95.8 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 120 (n=25, 24, 23, 19, 17, 24) | 95.8 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 30 (n=25, 24, 24, 21, 19, 24) | 100.0 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 120 (n=25, 24, 23, 19, 17, 24) | 95.7 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 30 (n=25, 24, 24, 21, 19, 24) | 100.0 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 30 (n=25, 24, 24, 21, 19, 24) | 33.3 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 30 (n=25, 24, 24, 21, 19, 24) | 87.5 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 90 (n=25, 24, 23, 20, 18, 24) | 100.0 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 120 (n=25, 24, 23, 19, 17, 24) | 100.0 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 90 (n=25, 24, 23, 20, 18, 24) | 82.6 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 90 (n=25, 24, 23, 20, 18, 24) | 95.7 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 90 (n=25, 24, 23, 20, 18, 24) | 21.7 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 120 (n=25, 24, 23, 19, 17, 24) | 52.2 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 30 (n=25, 24, 24, 21, 19, 24) | 100.0 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 120 (n=25, 24, 23, 19, 17, 24) | 91.3 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 90 (n=25, 24, 23, 20, 18, 24) | 50.0 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 30 (n=25, 24, 24, 21, 19, 24) | 85.7 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 30 (n=25, 24, 24, 21, 19, 24) | 81.0 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 30 (n=25, 24, 24, 21, 19, 24) | 100.0 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 30 (n=25, 24, 24, 21, 19, 24) | 81.0 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 90 (n=25, 24, 23, 20, 18, 24) | 75.0 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 90 (n=25, 24, 23, 20, 18, 24) | 100.0 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 90 (n=25, 24, 23, 20, 18, 24) | 75.0 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 120 (n=25, 24, 23, 19, 17, 24) | 84.2 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 120 (n=25, 24, 23, 19, 17, 24) | 100.0 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 120 (n=25, 24, 23, 19, 17, 24) | 94.7 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 120 (n=25, 24, 23, 19, 17, 24) | 73.7 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 90 (n=25, 24, 23, 20, 18, 24) | 83.3 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 90 (n=25, 24, 23, 20, 18, 24) | 100.0 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 30 (n=25, 24, 24, 21, 19, 24) | 94.7 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 120 (n=25, 24, 23, 19, 17, 24) | 94.1 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 90 (n=25, 24, 23, 20, 18, 24) | 72.2 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 120 (n=25, 24, 23, 19, 17, 24) | 100.0 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 30 (n=25, 24, 24, 21, 19, 24) | 57.9 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 30 (n=25, 24, 24, 21, 19, 24) | 89.5 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 120 (n=25, 24, 23, 19, 17, 24) | 76.5 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 120 (n=25, 24, 23, 19, 17, 24) | 94.1 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 30 (n=25, 24, 24, 21, 19, 24) | 100.0 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 90 (n=25, 24, 23, 20, 18, 24) | 38.9 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 120 (n=25, 24, 23, 19, 17, 24) | 83.3 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 90 (n=25, 24, 23, 20, 18, 24) | 91.7 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 30 (n=25, 24, 24, 21, 19, 24) | 100.0 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 30 (n=25, 24, 24, 21, 19, 24) | 66.7 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-3 Day 90 (n=25, 24, 23, 20, 18, 24) | 62.5 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 120 (n=25, 24, 23, 19, 17, 24) | 95.8 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-1 Day 90 (n=25, 24, 23, 20, 18, 24) | 87.5 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 120 (n=25, 24, 23, 19, 17, 24) | 41.7 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 30 (n=25, 24, 24, 21, 19, 24) | 29.2 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 30 (n=25, 24, 24, 21, 19, 24) | 95.8 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-4 Day 90 (n=25, 24, 23, 20, 18, 24) | 37.5 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Rate of Seroconversion to Each of Four Dengue Serotypes | Dengue-2 Day 120 (n=25, 24, 23, 19, 17, 24) | 95.8 percentage of participants |
Secondary
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes
Time frame: Days 30, 90 and 120 after 1st vaccination
Population: Participants from the Full Analysis, all enrolled participants, with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-1 (n=25, 24, 23, 19, 17, 24) | 223.2 titer | Standard Deviation 3.55 |
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-1 (n=25, 24, 24, 21, 19, 24) | 428.6 titer | Standard Deviation 2.28 |
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-4 (n=25, 24, 23, 20, 18, 23) | 6.6 titer | Standard Deviation 1.76 |
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-4 (n=25, 24, 23, 19, 17, 24) | 11.5 titer | Standard Deviation 2.5 |
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-3 (n=25, 24, 24, 21, 19, 24) | 62.3 titer | Standard Deviation 5.78 |
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-3 (n=25, 24, 23, 19, 17, 24) | 51.3 titer | Standard Deviation 2.28 |
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-4 (n=25, 24, 24, 21, 19, 24) | 8.2 titer | Standard Deviation 2.2 |
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-1 (n=25, 24, 23, 20, 18, 23) | 155.6 titer | Standard Deviation 4.26 |
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-2 (n=25, 24, 23, 19, 17, 24) | 1597.9 titer | Standard Deviation 2.27 |
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-2 (n=25, 24, 23, 20, 18, 23) | 1597.9 titer | Standard Deviation 2.81 |
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-2 (n=25, 24, 24, 21, 19, 24) | 6411.9 titer | Standard Deviation 7.83 |
| Group 1 (D0:TDV,P D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-3 (n=25, 24, 23, 20, 18, 23) | 32.0 titer | Standard Deviation 4.1 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-2 (n=25, 24, 23, 20, 18, 23) | 1758.7 titer | Standard Deviation 3.29 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-3 (n=25, 24, 23, 20, 18, 23) | 44.9 titer | Standard Deviation 4.04 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-1 (n=25, 24, 23, 19, 17, 24) | 136.5 titer | Standard Deviation 3.88 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-2 (n=25, 24, 24, 21, 19, 24) | 4843.3 titer | Standard Deviation 3.42 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-1 (n=25, 24, 23, 20, 18, 23) | 130.7 titer | Standard Deviation 2.75 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-4 (n=25, 24, 24, 21, 19, 24) | 19.4 titer | Standard Deviation 4.65 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-1 (n=25, 24, 24, 21, 19, 24) | 473.6 titer | Standard Deviation 2.6 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-4 (n=25, 24, 23, 20, 18, 23) | 10.3 titer | Standard Deviation 3.44 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-3 (n=25, 24, 23, 19, 17, 24) | 42.4 titer | Standard Deviation 3.7 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-3 (n=25, 24, 24, 21, 19, 24) | 151.0 titer | Standard Deviation 4.12 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-4 (n=25, 24, 23, 19, 17, 24) | 8.9 titer | Standard Deviation 2.7 |
| Group 2 (D0:TDV,TDV D90:P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-2 (n=25, 24, 23, 19, 17, 24) | 1478.9 titer | Standard Deviation 2.72 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-3 (n=25, 24, 23, 19, 17, 24) | 56.6 titer | Standard Deviation 4.43 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-3 (n=25, 24, 24, 21, 19, 24) | 70.3 titer | Standard Deviation 6.1 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-1 (n=25, 24, 23, 19, 17, 24) | 216.3 titer | Standard Deviation 6.23 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-4 (n=25, 24, 24, 21, 19, 24) | 11.6 titer | Standard Deviation 5 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-4 (n=25, 24, 23, 19, 17, 24) | 12.0 titer | Standard Deviation 3.58 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-2 (n=25, 24, 23, 19, 17, 24) | 1893.9 titer | Standard Deviation 2.89 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-3 (n=25, 24, 23, 20, 18, 23) | 28.7 titer | Standard Deviation 5.38 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-4 (n=25, 24, 23, 20, 18, 23) | 9.4 titer | Standard Deviation 3.62 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-1 (n=25, 24, 23, 20, 18, 23) | 142.2 titer | Standard Deviation 6.16 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-2 (n=25, 24, 24, 21, 19, 24) | 6274.1 titer | Standard Deviation 3.57 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-1 (n=25, 24, 24, 21, 19, 24) | 370.1 titer | Standard Deviation 3.87 |
| Group 3 (D0:TDV,TDV D90:TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-2 (n=25, 24, 23, 20, 18, 23) | 1814.4 titer | Standard Deviation 3.13 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-4 (n=25, 24, 23, 20, 18, 23) | 13.7 titer | Standard Deviation 3.6 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-1 (n=25, 24, 24, 21, 19, 24) | 45.6 titer | Standard Deviation 3.97 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-2 (n=25, 24, 24, 21, 19, 24) | 4953.8 titer | Standard Deviation 3.01 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-3 (n=25, 24, 24, 21, 19, 24) | 47.2 titer | Standard Deviation 5.69 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-4 (n=25, 24, 24, 21, 19, 24) | 45.6 titer | Standard Deviation 5.13 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-1 (n=25, 24, 23, 20, 18, 23) | 27.3 titer | Standard Deviation 3.11 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-2 (n=25, 24, 23, 20, 18, 23) | 1383.1 titer | Standard Deviation 2.82 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-3 (n=25, 24, 23, 20, 18, 23) | 20.0 titer | Standard Deviation 4.17 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-1 (n=25, 24, 23, 19, 17, 24) | 38.6 titer | Standard Deviation 2.7 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-2 (n=25, 24, 23, 19, 17, 24) | 1631.8 titer | Standard Deviation 3.49 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-3 (n=25, 24, 23, 19, 17, 24) | 30.5 titer | Standard Deviation 3.36 |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-4 (n=25, 24, 23, 19, 17, 24) | 23.2 titer | Standard Deviation 3.52 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-1 (n=25, 24, 23, 20, 18, 23) | 37.0 titer | Standard Deviation 5.91 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-3 (n=25, 24, 24, 21, 19, 24) | 62.0 titer | Standard Deviation 6.19 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-1 (n=25, 24, 24, 21, 19, 24) | 69.1 titer | Standard Deviation 5.51 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-4 (n=25, 24, 23, 19, 17, 24) | 25.5 titer | Standard Deviation 3.74 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-3 (n=25, 24, 23, 19, 17, 24) | 51.2 titer | Standard Deviation 3 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-4 (n=25, 24, 24, 21, 19, 24) | 21.5 titer | Standard Deviation 5.89 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-2 (n=25, 24, 24, 21, 19, 24) | 5419.6 titer | Standard Deviation 3.06 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-1 (n=25, 24, 23, 19, 17, 24) | 65.4 titer | Standard Deviation 5 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-2 (n=25, 24, 23, 19, 17, 24) | 1295.5 titer | Standard Deviation 3.22 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-3 (n=25, 24, 23, 20, 18, 23) | 27.7 titer | Standard Deviation 4.68 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-4 (n=25, 24, 23, 20, 18, 23) | 11.2 titer | Standard Deviation 3.62 |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-2 (n=25, 24, 23, 20, 18, 23) | 1288.7 titer | Standard Deviation 3.14 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-4 (n=25, 24, 23, 20, 18, 23) | 13.5 titer | Standard Deviation 6.85 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-1 (n=25, 24, 23, 20, 18, 23) | 127.6 titer | Standard Deviation 5.92 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-1 (n=25, 24, 23, 19, 17, 24) | 179.6 titer | Standard Deviation 4.85 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-4 (n=25, 24, 24, 21, 19, 24) | 17.4 titer | Standard Deviation 10.28 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-4 (n=25, 24, 23, 19, 17, 24) | 12.8 titer | Standard Deviation 5.81 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-2 (n=25, 24, 23, 19, 17, 24) | 1356.1 titer | Standard Deviation 5.37 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-3 (n=25, 24, 24, 21, 19, 24) | 37.4 titer | Standard Deviation 6.13 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-2 (n=25, 24, 24, 21, 19, 24) | 7315.3 titer | Standard Deviation 5.9 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 120 Dengue-3 (n=25, 24, 23, 19, 17, 24) | 25.9 titer | Standard Deviation 3.87 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 30 Dengue-1 (n=25, 24, 24, 21, 19, 24) | 391.4 titer | Standard Deviation 3.3 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-3 (n=25, 24, 23, 20, 18, 23) | 22.6 titer | Standard Deviation 4.87 |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Day 90 Dengue-2 (n=25, 24, 23, 20, 18, 23) | 1756.5 titer | Standard Deviation 5.8 |
Secondary
Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations
Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.
Time frame: various timepoints up to 30 days after each dose (Up to Day 120)
Population: Full Analysis Set included all enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 (D0:TDV,P D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 14 Dengue-2 | 52 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-3 | 0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 90 Dengue-3 | 0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-2 | 24 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-4 | 0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-2 | 56 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 7 Dengue-2 | 20 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-3 | 0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-2 | 64 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-1 | 0 percentage of participants |
| Group 1 (D0:TDV,P D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 21 Dengue-2 | 0 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 21 Dengue-2 | 0 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 14 Dengue-2 | 52 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-2 | 68 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-3 | 0 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-3 | 0 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 90 Dengue-3 | 4 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-2 | 12 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-1 | 0 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 7 Dengue-2 | 8 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-4 | 0 percentage of participants |
| Group 2 (D0:TDV,TDV D90:P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-2 | 72 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-4 | 0 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-1 | 0 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 14 Dengue-2 | 66 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-2 | 66 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 7 Dengue-2 | 12 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-3 | 0 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 21 Dengue-2 | 0 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-2 | 75 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 90 Dengue-3 | 0 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-2 | 8 percentage of participants |
| Group 3 (D0:TDV,TDV D90:TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-3 | 0 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 21 Dengue-2 | 4 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 7 Dengue-2 | 19 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-2 | 47 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-3 | 4 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-2 | 61 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-3 | 4 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-4 | 4 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 14 Dengue-2 | 33 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-1 | 4 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-2 | 14 percentage of participants |
| Group 4 (D0:TDVN,P D90:TDVN,P) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 90 Dengue-3 | 0 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-1 | 0 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-3 | 0 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 90 Dengue-3 | 0 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 21 Dengue-2 | 0 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-2 | 0 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-2 | 61 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-3 | 0 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 7 Dengue-2 | 19 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-2 | 52 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 14 Dengue-2 | 28 percentage of participants |
| Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-4 | 0 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-4 | 0 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 90 Dengue-3 | 0 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-1 | 0 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-3 | 0 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 11 Dengue-2 | 70 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 17 Dengue-2 | 12 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-3 | 0 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 9 Dengue-2 | 45 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 21 Dengue-2 | 0 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 7 Dengue-2 | 16 percentage of participants |
| Group 6 (D0:1/10TDV D90:1/10TDV) | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Day 14 Dengue-2 | 41 percentage of participants |