Dengue Fever
Conditions
Keywords
dengue fever, live attenuated tetravalent dengue vaccine, TDV, Drug therapy
Brief summary
The purpose of this study is to assess the safety of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) (previously DENVax) in healthy adults when given as either a subcutaneous (SC) or intradermal (ID) injection at two dose levels (low and high). The vaccine will be given as two doses 90 days apart. Safety assessments include injection site evaluation and adverse events. The immune response generated after vaccination will be assessed up to 9 months after the first vaccination.
Detailed description
This is a single center, placebo-controlled, randomized study assessing the safety and tolerability of two dose levels (low and high) of TDV administered subcutaneously or intradermally in two doses separated by an interval of 90 days. Initial dosing of low dose cohort will be performed and Day 21 safety assessed prior to administration of second dose to low dose cohort on Day 90 and initial dosing of high dose cohort. Day 21 safety for the high dose cohort will be assessed prior to administration of second dose for this cohort. Safety (local injection site reactions and solicited and unsolicited adverse events) will be assessed through Day 120 post-first (1 month after the second dose). Immunogenicity will be assessed at specified time points up to Day 120 post-prime (1 month after the second dose) and again on Days 180 and 270 (6 and 9 months post-first).
Interventions
BIOLOGICALTDV - Low Dose
TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8 x 10\^3 PFU, TDV-2: 5 x 10\^3 PFU, TDV-3: 1 x 10\^4 PFU, and TDV-4: 2 x 10\^5 PFU, total virus per dose 2.2 x 10\^5 PFU
BIOLOGICALTDV - High Dose
TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2 x 10\^4 PFU, TDV-2: 5 x 10\^4 PFU, TDV-3: 1 x 10\^5 PFU, and TDV-4: 3 x 10\^5 PFU, total virus per dose : 4.7 x 10\^5 PFU. TDV administered intradermally.
BIOLOGICALPlacebo
Phosphate Buffered Saline (PBS)
Sponsors
Inviragen Inc.
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
* Is male or female aged 18 to 45 years, inclusive, at time of screening. * Is in good health as determined by medical history, physical examination, and clinical safety laboratory examinations. * Has body mass index (BMI) in the range 18-27 kilogram per square meter (kg/m\^2). * Has negative serology for Human Immunodeficiency Virus (HIV), Hepatitis C antibody, and Hepatitis B surface antigen. * Females of child bearing potential must have a negative urine pregnancy test result during screening and a negative urine pregnancy test immediately prior to vaccination and be willing to use oral, implantable, transdermal or injectable contraceptives or another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicidal, cervical cap, use of condom by the sexual partner or a sterile sexual partner, or abstinence) from screening until after the last blood sample (at Day 270). * Is willing and able to give written informed consent to participate. * Is willing and able to communicate with the Investigator and understand the requirements of the study.
Exclusion criteria
* Has any condition which would limit the participant's ability to complete the study. * Clinically significant hematological, renal, hepatic, pulmonary, central nervous system, cardiovascular or gastrointestinal disorders. * Has abnormal electrocardiogram (ECG). * Has febrile illness (temperature greater than or equal to (\>=) 38 degree Celsius (°C) or 100.4 degree Fahrenheit (°F) or moderate or severe acute illness or infection within three days of vaccination. * Diabetes mellitus. * Has allergy to penicillin, neomycin, streptomycin or gentamicin. * Hypersensitivity to any vaccine. * Seropositivity to any of the four dengue serotypes (TDV-1, TDV-2, TDV-3 or TDV-4), yellow fever (YF) virus or West Nile (WN) virus. * Has previous vaccination (in a clinical trial or with an approved product) against flaviviruses including dengue, YF or WN. * Has planned vaccination against YF throughout the duration of this study. * Has receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study. * Travel to dengue-endemic areas in the two months prior to study start or planned travel to dengue-endemic areas during the study period, including low altitude regions of Colombia where dengue is endemic. * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months prior to the first vaccination, or long- term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 0.5 milligram per kilogram per day \[mg/kg/day\]) prior to the first vaccination. * Has a history of recurring migraines or on prescription medication for treatment of recurring headaches or migraines. * Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination. * Use of prescription or over the counter medications 7 days before the first vaccination (Day 0), excluding contraceptives and painkillers containing NSAIDs or acetaminophen, cold remedies, hormone replacement and antihistamines. * Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids. * Receipt of any other investigational product or participation in any other clinical trial in the month before the first vaccination (Day 0) or during the conduct of this study. * Receipt of blood products or immunoglobulins 8 weeks before the first vaccination (Day 0) or planned use during the study period. * Donation of blood 6 weeks before the first vaccination (Day 0) or at any time during the study. * Females who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Local Injection Site Reaction by Severity | Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination) | Solicited local reactions were reported using a participant diary. Pain was categorized as Mild (aware of pain but it does not interfere with daily activity and no pain medication is taken); Moderate (aware of pain; there is interference with daily activity or it requires use of pain medication); Severe (aware of pain and it prevents daily activity), redness was categorized as Mild (greater than \[\>\] 15 millimeter \[mm\]); Moderate as (15-30 mm); Severe (\>30 mm), swelling was categorized as Mild (\<15 mm); Moderate (15-30 mm); Severe (\>30 mm), and itching was categorized as Mild (slight itching at injection site); Moderate (moderate itching at injection extremity); Severe (itching over entire body). |
| Number of Participants With Systemic Adverse Events (AEs) by Severity | Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination) | Solicited systemic AEs were reported using a participant diary. Solicited systemic AEs included fever (\>= 37.8°C), headache, muscle pain, joint pain, eye pain, photophobia, fatigue, body rash, nausea, vomiting and other (any other symptom not listed in the diary) and were categorized as Mild: transient symptoms, discomfort noticed but easily tolerated, no interference to normal daily activities; Moderate: marked symptoms, moderate interference with daily activities; Severe: considerable interference with daily activities. |
| Number of Participants With Solicited Local and Systemic AEs | Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination) | — |
| Number of Participants With Unsolicited Local and Systemic AEs | Baseline up to 30 days after second vaccination (Day 120) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Durability of Immune Response | Days 180 and 270 | Immune response was considered durable if the participant had detectable neutralizing antibodies (seroconversion) to all 4 dengue serotypes at 90 and 180 days after the second dose (i.e. Days 180 and 270, respectively). Seroconversion is defined as post-vaccination PRNT(50) titer \>=10 where pre-vaccination PRNT 50 titer \<10, or post-vaccination PRNT(50) Titer \>=4-fold the pre-vaccination PRNT(50) titer value where pre-vaccination PRNT(50) titer \>=10. Percentage of participants with seroconversion on Days 180 and 270 are based on the number of participants in the FAS with non-missing MN assay samples at each visit. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. |
| Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Baseline and at multiple time points up to Day 14 after each vaccination | Serotype-specific vaccine viremia was assessed for the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. Only those serotypes and time-points where at least 1 participant had serotype-specific vaccine viremia detection were reported. |
| Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Days 14, 30, 60 and 90 after first vaccination | GMT was assessed for the four dengue serotypes: Dengue TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95 percent (%) confidence interval (CIs) were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers. |
| Titers of Vaccine Viremia | 14 Days after each vaccination | — |
| Duration of Vaccine Viremia | 14 Days after each vaccination | — |
| GMTs of All Four Dengue Serotypes After Second Vaccination | Days 14 and 30 after second vaccination (Day 104 and 120 respectively) | GMT was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95% CIs were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers. |
| Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Days 14, 30, 60 and 90 after first vaccination | Seroconversion was defined as a Plaque Reduction Neutralization Test (PRNT) titer resulting in 50% reduction in plaques (PRNT\[50\]) \>=10 (if the pre-vaccination PRNT\[50\] value was \<10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was \>=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT\[50\] value was \>=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit. |
| Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Days 14 and 30 after second vaccination (Days 104 and 120 respectively) | Seroconversion was defined as a PRNT titer resulting in 50% reduction in plaques (PRNT\[50\]) \>=10 (if the pre-vaccination PRNT\[50\] value was \<10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was \>=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT\[50\] value was \>=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit (n). |
Countries
Colombia
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in Colombia from 11 October 2010 to 09 November 2011.
Pre-assignment details
Healthy male and female participants were enrolled in 1 of the 8 treatment groups: Low Dose Subcutaneous:TDV, Low Dose Subcutaneous: Placebo, Low Dose Intradermal:TDV, Low Dose Intradermal:Placebo, High Dose Subcutaneous:TDV, High Dose Subcutaneous:Placebo, High Dose Intradermal:TDV, High Dose Intradermal:Placebo.
Participants by arm
| Arm | Count |
|---|---|
| Low Dose Subcutaneous: TDV TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU. | 19 |
| Low Dose Subcutaneous: Placebo TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). | 5 |
| Low Dose Intradermal: TDV TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8\*10\^3 PFU, TDV-2: 5\*10\^3 PFU, TDV-3: 1\*10\^4 PFU, and TDV-4: 2\*10\^5 PFU, total virus per dose: 2.2\*10\^5 PFU. | 21 |
| Low Dose Intradermal: Placebo TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). | 3 |
| High Dose Subcutaneous: TDV TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU. | 21 |
| High Dose Subcutaneous: Placebo TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). | 4 |
| High Dose Intradermal: TDV TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2\*10\^4 PFU, TDV-2: 5\*10\^4 PFU, TDV-3: 1\*10\^5 PFU, and TDV-4: 3\*10\^5 PFU, total virus per dose: 4.7\*10\^5 PFU. | 18 |
| High Dose Intradermal: Placebo TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). | 5 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | High Dose Intradermal: Placebo | High Dose Intradermal: TDV | High Dose Subcutaneous: Placebo | Low Dose Subcutaneous: TDV | High Dose Subcutaneous: TDV | Low Dose Intradermal: Placebo | Low Dose Intradermal: TDV | Low Dose Subcutaneous: Placebo |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized >=65 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized Greater than or equal to (>=) 18 and <65 years | 96 participants | 5 participants | 18 participants | 4 participants | 19 participants | 21 participants | 3 participants | 21 participants | 5 participants |
| Age, Customized Less than (<) 18 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 89 participants | 4 participants | 18 participants | 4 participants | 17 participants | 21 participants | 3 participants | 17 participants | 5 participants |
| Race/Ethnicity, Customized White | 7 participants | 1 participants | 0 participants | 0 participants | 2 participants | 0 participants | 0 participants | 4 participants | 0 participants |
| Sex: Female, Male Female | 67 Participants | 4 Participants | 12 Participants | 3 Participants | 14 Participants | 17 Participants | 2 Participants | 11 Participants | 4 Participants |
| Sex: Female, Male Male | 29 Participants | 1 Participants | 6 Participants | 1 Participants | 5 Participants | 4 Participants | 1 Participants | 10 Participants | 1 Participants |
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 | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 19 | 5 / 5 | 13 / 21 | 3 / 3 | 15 / 21 | 2 / 4 | 13 / 18 | 3 / 5 |
| serious Total, serious adverse events | 0 / 19 | 0 / 5 | 0 / 21 | 1 / 3 | 1 / 21 | 0 / 4 | 0 / 18 | 0 / 5 |
Outcome results
Primary
Number of Participants With Local Injection Site Reaction by Severity
Solicited local reactions were reported using a participant diary. Pain was categorized as Mild (aware of pain but it does not interfere with daily activity and no pain medication is taken); Moderate (aware of pain; there is interference with daily activity or it requires use of pain medication); Severe (aware of pain and it prevents daily activity), redness was categorized as Mild (greater than \[\>\] 15 millimeter \[mm\]); Moderate as (15-30 mm); Severe (\>30 mm), swelling was categorized as Mild (\<15 mm); Moderate (15-30 mm); Severe (\>30 mm), and itching was categorized as Mild (slight itching at injection site); Moderate (moderate itching at injection extremity); Severe (itching over entire body).
Time frame: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Population: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Severe | 4 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Moderate | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Itching: Moderate | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Itching: Mild | 4 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Pain: Moderate | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Pain: Mild | 12 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Severe | 4 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Moderate | 2 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Mild | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Mild | 1 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Pain: Mild | 1 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Moderate | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Itching: Mild | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Moderate | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Itching: Moderate | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Mild | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Mild | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Pain: Moderate | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Pain: Moderate | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Pain: Mild | 8 participants |
| Low Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Mild | 12 participants |
| Low Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Moderate | 8 participants |
| Low Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Severe | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Mild | 10 participants |
| Low Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Severe | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Itching: Mild | 12 participants |
| Low Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Itching: Moderate | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Moderate | 4 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Itching: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Mild | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Itching: Mild | 1 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Pain: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Pain: Mild | 2 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Mild | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Mild | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Moderate | 5 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Itching: Moderate | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Severe | 7 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Itching: Mild | 7 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Mild | 2 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Moderate | 2 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Pain: Moderate | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Severe | 3 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Local Injection Site Reaction by Severity | Pain: Mild | 8 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Moderate | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Pain: Moderate | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Itching: Moderate | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Itching: Mild | 1 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Mild | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Moderate | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Mild | 1 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Pain: Mild | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Mild | 5 participants |
| High Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Severe | 3 participants |
| High Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Pain: Moderate | 2 participants |
| High Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Moderate | 5 participants |
| High Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Severe | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Itching: Mild | 13 participants |
| High Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Pain: Mild | 10 participants |
| High Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Itching: Moderate | 2 participants |
| High Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Moderate | 9 participants |
| High Dose Intradermal: TDV | Number of Participants With Local Injection Site Reaction by Severity | Redness: Mild | 5 participants |
| High Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Pain: Mild | 1 participants |
| High Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Moderate | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Mild | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Moderate | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Redness: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Swelling: Mild | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Itching: Mild | 1 participants |
| High Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Pain: Moderate | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Local Injection Site Reaction by Severity | Itching: Moderate | 0 participants |
Primary
Number of Participants With Solicited Local and Systemic AEs
Time frame: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Population: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose Subcutaneous: TDV | Number of Participants With Solicited Local and Systemic AEs | Local solicited AEs | 15 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Solicited Local and Systemic AEs | Systemic solicited AEs | 17 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Solicited Local and Systemic AEs | Local solicited AEs | 1 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Solicited Local and Systemic AEs | Systemic solicited AEs | 4 participants |
| Low Dose Intradermal: TDV | Number of Participants With Solicited Local and Systemic AEs | Local solicited AEs | 20 participants |
| Low Dose Intradermal: TDV | Number of Participants With Solicited Local and Systemic AEs | Systemic solicited AEs | 17 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Solicited Local and Systemic AEs | Local solicited AEs | 2 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Solicited Local and Systemic AEs | Systemic solicited AEs | 2 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Solicited Local and Systemic AEs | Local solicited AEs | 14 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Solicited Local and Systemic AEs | Systemic solicited AEs | 17 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Solicited Local and Systemic AEs | Local solicited AEs | 1 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Solicited Local and Systemic AEs | Systemic solicited AEs | 3 participants |
| High Dose Intradermal: TDV | Number of Participants With Solicited Local and Systemic AEs | Systemic solicited AEs | 17 participants |
| High Dose Intradermal: TDV | Number of Participants With Solicited Local and Systemic AEs | Local solicited AEs | 18 participants |
| High Dose Intradermal: Placebo | Number of Participants With Solicited Local and Systemic AEs | Local solicited AEs | 1 participants |
| High Dose Intradermal: Placebo | Number of Participants With Solicited Local and Systemic AEs | Systemic solicited AEs | 4 participants |
Primary
Number of Participants With Systemic Adverse Events (AEs) by Severity
Solicited systemic AEs were reported using a participant diary. Solicited systemic AEs included fever (\>= 37.8°C), headache, muscle pain, joint pain, eye pain, photophobia, fatigue, body rash, nausea, vomiting and other (any other symptom not listed in the diary) and were categorized as Mild: transient symptoms, discomfort noticed but easily tolerated, no interference to normal daily activities; Moderate: marked symptoms, moderate interference with daily activities; Severe: considerable interference with daily activities.
Time frame: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Population: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Moderate | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Mild | 6 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Moderate | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Moderate | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Severe | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Severe | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Moderate | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Severe | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Severe | 2 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Moderate | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Mild | 4 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Mild | 4 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Severe | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Severe | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Mild | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Moderate | 7 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Severe | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Mild | 2 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Severe | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Moderate | 3 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Mild | 9 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Mild | 10 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Mild | 5 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Severe | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Moderate | 2 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Moderate | 2 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Mild | 4 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Moderate | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Severe | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Mild | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Moderate | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Mild | 4 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Mild | 1 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Moderate | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Mild | 2 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Moderate | 1 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Moderate | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Mild | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Mild | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Moderate | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Mild | 1 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Moderate | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Moderate | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Moderate | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Mild | 2 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Moderate | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Mild | 2 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Mild | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Mild | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Mild | 1 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Moderate | 1 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Severe | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Moderate | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Mild | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Moderate | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Moderate | 4 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Mild | 2 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Moderate | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Severe | 1 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Mild | 12 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Mild | 3 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Moderate | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Severe | 1 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Mild | 2 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Moderate | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Severe | 1 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Mild | 8 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Moderate | 1 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Severe | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Mild | 6 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Mild | 7 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Severe | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Moderate | 4 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Severe | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Moderate | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Severe | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Severe | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Mild | 1 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Moderate | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Severe | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Mild | 4 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Moderate | 2 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Severe | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Mild | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Moderate | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Mild | 2 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Moderate | 4 participants |
| Low Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Mild | 1 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Mild | 1 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Mild | 1 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Mild | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Mild | 1 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Mild | 2 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Mild | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Mild | 2 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Severe | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Mild | 1 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Moderate | 1 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Mild | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Moderate | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Mild | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Mild | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Moderate | 2 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Severe | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Severe | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Severe | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Mild | 9 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Mild | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Moderate | 4 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Moderate | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Moderate | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Moderate | 2 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Moderate | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Severe | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Severe | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Moderate | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Moderate | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Mild | 4 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Moderate | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Severe | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Severe | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Mild | 4 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Mild | 2 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Severe | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Mild | 4 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Mild | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Moderate | 2 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Mild | 6 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Severe | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Severe | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Mild | 5 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Mild | 3 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Moderate | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Mild | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Mild | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Mild | 1 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Mild | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Moderate | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Mild | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Mild | 1 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Moderate | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Mild | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Moderate | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Moderate | 1 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Mild | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Mild | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Moderate | 1 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Moderate | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Moderate | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Mild | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Moderate | 1 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Moderate | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Moderate | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Severe | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Mild | 1 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Moderate | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Severe | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Severe | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Moderate | 2 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Severe | 1 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Mild | 10 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Moderate | 3 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Severe | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Moderate | 1 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Moderate | 1 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Severe | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Mild | 3 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Mild | 6 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Mild | 7 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Mild | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Moderate | 1 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Severe | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Mild | 1 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Moderate | 2 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Moderate | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Moderate | 1 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Severe | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Severe | 1 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Mild | 4 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Mild | 4 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Severe | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Mild | 6 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Severe | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Mild | 4 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Mild | 3 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Moderate | 0 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Severe | 2 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Moderate | 2 participants |
| High Dose Intradermal: TDV | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Moderate | 5 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Mild | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Mild | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Moderate | 2 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Mild | 2 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Moderate | 1 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Mild | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Moderate | 1 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Moderate | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Mild | 4 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Moderate | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Moderate | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Headache: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fever: Moderate | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Muscle pain: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Moderate | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Fatigue: Moderate | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Moderate | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Body Rash: Mild | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Mild | 1 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Other: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Photophobia: Mild | 2 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Moderate | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Joint pain: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Nausea: Mild | 2 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Mild | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Vomiting: Severe | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Mild | 1 participants |
| High Dose Intradermal: Placebo | Number of Participants With Systemic Adverse Events (AEs) by Severity | Eye pain: Severe | 0 participants |
Primary
Number of Participants With Unsolicited Local and Systemic AEs
Time frame: Baseline up to 30 days after second vaccination (Day 120)
Population: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose Subcutaneous: TDV | Number of Participants With Unsolicited Local and Systemic AEs | Local unsolicited AEs | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants With Unsolicited Local and Systemic AEs | Systemic unsolicited AEs | 18 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Unsolicited Local and Systemic AEs | Local unsolicited AEs | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants With Unsolicited Local and Systemic AEs | Systemic unsolicited AEs | 5 participants |
| Low Dose Intradermal: TDV | Number of Participants With Unsolicited Local and Systemic AEs | Local unsolicited AEs | 3 participants |
| Low Dose Intradermal: TDV | Number of Participants With Unsolicited Local and Systemic AEs | Systemic unsolicited AEs | 16 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Unsolicited Local and Systemic AEs | Local unsolicited AEs | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants With Unsolicited Local and Systemic AEs | Systemic unsolicited AEs | 3 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Unsolicited Local and Systemic AEs | Local unsolicited AEs | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants With Unsolicited Local and Systemic AEs | Systemic unsolicited AEs | 16 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Unsolicited Local and Systemic AEs | Local unsolicited AEs | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants With Unsolicited Local and Systemic AEs | Systemic unsolicited AEs | 2 participants |
| High Dose Intradermal: TDV | Number of Participants With Unsolicited Local and Systemic AEs | Systemic unsolicited AEs | 14 participants |
| High Dose Intradermal: TDV | Number of Participants With Unsolicited Local and Systemic AEs | Local unsolicited AEs | 4 participants |
| High Dose Intradermal: Placebo | Number of Participants With Unsolicited Local and Systemic AEs | Local unsolicited AEs | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants With Unsolicited Local and Systemic AEs | Systemic unsolicited AEs | 3 participants |
Secondary
Duration of Vaccine Viremia
Time frame: 14 Days after each vaccination
Population: Due to the low prevalence of vaccine viremia, estimates of average titer duration of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.
Secondary
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
GMT was assessed for the four dengue serotypes: Dengue TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95 percent (%) confidence interval (CIs) were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.
Time frame: Days 14, 30, 60 and 90 after first vaccination
Population: The full analysis set (FAS) included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing microneutralization (MN) Assay samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 7.75 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 181.80 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 25.82 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 30.99 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 34.57 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 11.16 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 12.45 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 17.93 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 13.39 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 363.60 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 230.44 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-1(n=19, 5, 21, 3, 21, 4, 18, 5) | 49.79 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 33.33 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 34.57 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 6.94 titer |
| Low Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 49.79 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-1(n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 38.70 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 262.51 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 50.40 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 28.29 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 22.08 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 60.43 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 7.43 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 20.00 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 309.61 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 11.04 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-1(n=19, 5, 21, 3, 21, 4, 18, 5) | 48.76 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 43.44 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 475.52 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 67.83 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 57.51 titer |
| Low Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 26.48 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-1(n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 6.30 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 1912.01 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 6.73 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 111.29 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 6.22 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-1(n=19, 5, 21, 3, 21, 4, 18, 5) | 208.37 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 8682.13 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 34.57 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 1280.00 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 42.03 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.58 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 30.99 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 103.28 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 9.06 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.71 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 26.04 titer |
| High Dose Subcutaneous: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 109.09 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-1(n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Subcutaneous: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-1(n=19, 5, 21, 3, 21, 4, 18, 5) | 153.96 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 7.64 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 10.60 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 22.88 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 72.66 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 80.00 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 2370.24 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 11.30 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 135.92 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 666.63 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 11.22 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 838.01 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 307.91 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 148.14 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 117.58 titer |
| High Dose Intradermal: TDV | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 86.40 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-1(n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
| High Dose Intradermal: Placebo | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.00 titer |
Secondary
GMTs of All Four Dengue Serotypes After Second Vaccination
GMT was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95% CIs were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.
Time frame: Days 14 and 30 after second vaccination (Day 104 and 120 respectively)
Population: The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received. Here 'n' is number of participants with non-missing MN Assay samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 69.14 titer |
| Low Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 73.03 titer |
| Low Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 222.18 titer |
| Low Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 206.55 titer |
| Low Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-1(n=19, 5, 21, 3, 19, 4, 17, 3) | 128.55 titer |
| Low Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 20.74 titer |
| Low Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 21.51 titer |
| Low Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 111.09 titer |
| Low Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| Low Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-1(n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 144.92 titer |
| Low Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 341.84 titer |
| Low Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 88.33 titer |
| Low Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 314.76 titer |
| Low Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 48.76 titer |
| Low Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 72.46 titer |
| Low Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-1(n=19, 5, 21, 3, 19, 4, 17, 3) | 92.81 titer |
| Low Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 137.92 titer |
| Low Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-1(n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| Low Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| High Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 78.56 titer |
| High Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 1382.48 titer |
| High Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-1(n=19, 5, 21, 3, 19, 4, 17, 3) | 181.82 titer |
| High Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 63.50 titer |
| High Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 1536.13 titer |
| High Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 10.39 titer |
| High Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 244.39 titer |
| High Dose Subcutaneous: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 9.64 titer |
| High Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-1(n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| High Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| High Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| High Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| High Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Subcutaneous: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 250.56 titer |
| High Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-1(n=19, 5, 21, 3, 19, 4, 17, 3) | 160.00 titer |
| High Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 16.99 titer |
| High Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 230.93 titer |
| High Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 589.88 titer |
| High Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 271.84 titer |
| High Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 543.69 titer |
| High Dose Intradermal: TDV | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 27.71 titer |
| High Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
| High Dose Intradermal: Placebo | GMTs of All Four Dengue Serotypes After Second Vaccination | Day 120 TDV-1(n=19, 5, 21, 3, 19, 4, 17, 3) | 5.00 titer |
Secondary
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Serotype-specific vaccine viremia was assessed for the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. Only those serotypes and time-points where at least 1 participant had serotype-specific vaccine viremia detection were reported.
Time frame: Baseline and at multiple time points up to Day 14 after each vaccination
Population: The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 104 TDV-2 (n= 19, 5, 21, 3, 18, 4, 17, 3) | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 11 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 4 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-4 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 5 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 14 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 3 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-4 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 1 participants |
| Low Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 14 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-4 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 104 TDV-2 (n= 19, 5, 21, 3, 18, 4, 17, 3) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 11 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-4 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 11 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 7 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 2 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-4 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 1 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-4 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 6 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 14 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 3 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 104 TDV-2 (n= 19, 5, 21, 3, 18, 4, 17, 3) | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 1 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 11 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-4 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-4 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 104 TDV-2 (n= 19, 5, 21, 3, 18, 4, 17, 3) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| Low Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 14 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 9 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 14 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 10 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 104 TDV-2 (n= 19, 5, 21, 3, 18, 4, 17, 3) | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 6 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-4 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-4 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 1 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 11 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 17 participants |
| High Dose Subcutaneous: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-4 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 14 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 104 TDV-2 (n= 19, 5, 21, 3, 18, 4, 17, 3) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 11 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Subcutaneous: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-4 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 1 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 1 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 1 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-4 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 5 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 104 TDV-2 (n= 19, 5, 21, 3, 18, 4, 17, 3) | 0 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 14 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 8 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 4 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-4 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 11 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 5 participants |
| High Dose Intradermal: TDV | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 1 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 5 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 104 TDV-2 (n= 19, 5, 21, 3, 18, 4, 17, 3) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 101 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 99 TDV-3 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-4 (n= 19, 5, 21, 3, 19, 4, 17, 3) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 9 TDV-3 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 7 TDV-4 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 14 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 11 TDV-2 (n= 19, 5, 21, 3, 21, 4, 18, 5) | 0 participants |
| High Dose Intradermal: Placebo | Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination | Day 97 TDV-2 (n= 19, 5, 21, 3, 21, 3, 17, 3) | 0 participants |
Secondary
Percentage of Participants With Durability of Immune Response
Immune response was considered durable if the participant had detectable neutralizing antibodies (seroconversion) to all 4 dengue serotypes at 90 and 180 days after the second dose (i.e. Days 180 and 270, respectively). Seroconversion is defined as post-vaccination PRNT(50) titer \>=10 where pre-vaccination PRNT 50 titer \<10, or post-vaccination PRNT(50) Titer \>=4-fold the pre-vaccination PRNT(50) titer value where pre-vaccination PRNT(50) titer \>=10. Percentage of participants with seroconversion on Days 180 and 270 are based on the number of participants in the FAS with non-missing MN assay samples at each visit. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution.
Time frame: Days 180 and 270
Population: The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-4 | 63.2 percentage of participants |
| Low Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-4 | 42.1 percentage of participants |
| Low Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-2 | 73.7 percentage of participants |
| Low Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-1 | 68.4 percentage of participants |
| Low Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-3 | 94.7 percentage of participants |
| Low Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-2 | 73.7 percentage of participants |
| Low Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-1 | 78.9 percentage of participants |
| Low Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-3 | 68.4 percentage of participants |
| Low Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-1 | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-4 | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-4 | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-2 | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-3 | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-1 | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-2 | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-3 | 20.0 percentage of participants |
| Low Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-1 | 90.5 percentage of participants |
| Low Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-2 | 81.0 percentage of participants |
| Low Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-4 | 57.1 percentage of participants |
| Low Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-3 | 100.0 percentage of participants |
| Low Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-2 | 81.0 percentage of participants |
| Low Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-1 | 66.7 percentage of participants |
| Low Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-3 | 76.2 percentage of participants |
| Low Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-4 | 71.4 percentage of participants |
| Low Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-3 | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-1 | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-1 | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-4 | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-4 | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-2 | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-2 | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-3 | 0 percentage of participants |
| High Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-3 | 94.7 percentage of participants |
| High Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-1 | 100.0 percentage of participants |
| High Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-2 | 100.0 percentage of participants |
| High Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-4 | 31.6 percentage of participants |
| High Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-1 | 89.5 percentage of participants |
| High Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-2 | 100.0 percentage of participants |
| High Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-3 | 57.9 percentage of participants |
| High Dose Subcutaneous: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-4 | 15.8 percentage of participants |
| High Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-4 | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-2 | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-3 | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-1 | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-2 | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-1 | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-3 | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-4 | 0 percentage of participants |
| High Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-2 | 94.1 percentage of participants |
| High Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-2 | 94.1 percentage of participants |
| High Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-1 | 100.0 percentage of participants |
| High Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-1 | 94.1 percentage of participants |
| High Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-3 | 88.2 percentage of participants |
| High Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-4 | 52.9 percentage of participants |
| High Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 270 TDV-4 | 35.3 percentage of participants |
| High Dose Intradermal: TDV | Percentage of Participants With Durability of Immune Response | Day 180 TDV-3 | 100.0 percentage of participants |
| High Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-1 | 0 percentage of participants |
| High Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-4 | 0 percentage of participants |
| High Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-3 | 0 percentage of participants |
| High Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-1 | 0 percentage of participants |
| High Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-2 | 0 percentage of participants |
| High Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 180 TDV-2 | 0 percentage of participants |
| High Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-4 | 0 percentage of participants |
| High Dose Intradermal: Placebo | Percentage of Participants With Durability of Immune Response | Day 270 TDV-3 | 0 percentage of participants |
Secondary
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Seroconversion was defined as a Plaque Reduction Neutralization Test (PRNT) titer resulting in 50% reduction in plaques (PRNT\[50\]) \>=10 (if the pre-vaccination PRNT\[50\] value was \<10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was \>=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT\[50\] value was \>=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit.
Time frame: Days 14, 30, 60 and 90 after first vaccination
Population: The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 63.2 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 78.9 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 73.7 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 10.5 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 63.2 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 89.5 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 36.8 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 89.5 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 47.4 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 68.4 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 21.1 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 63.2 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 68.4 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 57.9 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 52.6 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 73.7 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 66.7 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 90.5 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 42.9 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 33.3 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 71.4 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 71.4 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 52.4 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 66.7 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 76.2 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 81.0 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 66.7 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 76.2 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 66.7 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 19.0 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 71.4 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 42.9 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 33.3 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 100.0 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 89.5 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 52.4 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 94.7 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 94.7 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 94.7 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 23.8 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 95.2 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 14.3 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 100.0 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 5.3 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 26.3 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 81.0 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 90.5 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 9.5 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 88.2 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 83.3 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 100 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 41.2 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 88.9 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 66.7 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 100 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 88.9 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 83.3 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 94.4 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 33.3 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 94.4 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 94.1 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 11.1 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 38.9 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-2 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-3 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-1 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-3 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 30 TDV-2 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 90 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-4 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 60 TDV-1 (n=19, 5, 21, 3, 19, 4, 18, 5) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination | Day 14 TDV-4 (n=19, 5, 21, 3, 21, 4, 18, 5) | 0 percentage of participants |
Secondary
Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Seroconversion was defined as a PRNT titer resulting in 50% reduction in plaques (PRNT\[50\]) \>=10 (if the pre-vaccination PRNT\[50\] value was \<10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was \>=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT\[50\] value was \>=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit (n).
Time frame: Days 14 and 30 after second vaccination (Days 104 and 120 respectively)
Population: The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre- and post-dosing blood samples were received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 94.7 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 89.5 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 94.7 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 84.2 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 73.7 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 78.9 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 73.7 percentage of participants |
| Low Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 78.9 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 100.0 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 76.2 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 95.2 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 95.2 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 76.2 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 100.0 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 100.0 percentage of participants |
| Low Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 90.5 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| Low Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 55.6 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 47.4 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Subcutaneous: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Subcutaneous: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 76.5 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 94.1 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 88.2 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Intradermal: TDV | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 100.0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-3 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-1 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-2 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-4 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-3 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-4 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 104 TDV-2 (n=19, 5, 21, 3, 18, 4, 17, 3) | 0 percentage of participants |
| High Dose Intradermal: Placebo | Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination | Day 120 TDV-1 (n=19, 5, 21, 3, 19, 4, 17, 3) | 0 percentage of participants |
Secondary
Titers of Vaccine Viremia
Time frame: 14 Days after each vaccination
Population: Due to the low prevalence of vaccine viremia, estimates of average titer levels of viral RNA within study groups would not be meaningful. Therefore as per change in planned analysis only number of participants with positive vaccine viremia of all four vaccine strain serotypes after first and second vaccination was reported.