Dengue
Conditions
Brief summary
This descriptive study will evaluate the safety and immunogenicity of different formulations of the WRAIR dengue vaccine compared to a placebo.
Detailed description
Subjects will be randomized into one of three groups. One group will receive a placebo vaccine and the other two will receive different dengue vaccine formations. Each subject will receive two doses six months apart. All subjects will have 11 venipunctures during 11 visits (i.e., screening plus 10 study visits) over a period of nine months.
Interventions
BIOLOGICALT-DEN F17
A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
BIOLOGICALT-DEN F-19
A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
OTHERPlacebo Comparator
A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
Sponsors
GlaxoSmithKline
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* A healthy male or female adult 20-25 years of age (≥20 years of age and ≤25 years of age) at the time of vaccination; * Free of obvious health problems as established by medical history and physical examination before entering into the study; * Written informed consent obtained from the subject; * Able to read the Subject Information Sheet and Consent Form; * Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study; * females must be of non-childbearing potential, i.e. surgically sterilized or, if of childbearing potential, she must be abstinent or on adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception, e.g. progestin implantable, cutaneous hormonal patch or injectable contraceptives) for 30 days prior to vaccination, have a negative pregnancy test within 48 hours prior to vaccination and must agree to continue such precautions for 60 days after completion of the vaccination series
Exclusion criteria
* Pregnant or lactating female, planning to become pregnant or planning to discontinue abstinence or contraceptive precautions; * History of any neurological or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood; * History of drug abuse or alcohol consumption (more than 2 drinks per day); * History of allergic disease/reaction likely to be exacerbated by any component of the vaccine; * Acute or chronic, pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect, as determined by physical examination or laboratory tests; * Any confirmed or suspected immunosuppressive or immunodeficient condition or seropositive for HBsAg, anti-HCV or anti-HIV; * Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever); * Chronic hepatomegaly, right upper quadrant abdominal pain or tenderness; * Chronic splenomegaly, left upper quadrant abdominal pain or tenderness; * Hypertension; chest pain, palpitations, dizziness, shortness of breath, arrhythmias or friction rubs; * Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine (includes placebo) or planned use during the study period; * Planned administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of the study vaccine/placebo and ending 30 days after the second dose; * A planned move to a location that will prohibit participating in the trial for 9 months after the initial vaccination; * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 90 days preceding the first dose or planned administration during the study period. For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed; * Administration of immunoglobulins and/or blood products within 90 days preceding the first dose or planned administration during the study period; * Any chronic systemic drug therapy to be continued during the study period (except for vitamin/mineral supplements or routine treatment for gastro-esophageal reflux); * No easy access to a fixed or mobile telephone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | 0-21 days after dose 1 | Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month) |
| Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | 30 and 90 days after dose 2 | Neutralizing antibody geometric mean titer (GMT) to DEN types 1, 2, 3 and 4 will be measured 30 and 90 days following the administration of the 2nd dose (6 month) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period | 9 months | Number of subjects experiencing serious adverse events (SAEs) throughout the entire 9 month study period |
| Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | within 31 days after each vaccine dose | Laboratory valuesabove the alert values within 31 days (days 0-30) after each vaccine dose. Change from baseline in hematological and biochemical levels with respect to normal ranges. PI(D2, 5, 8, 12) = Post Dose 1, Days 2, 5, 8 and 12 PI(D5, 12,14) = Post Dose 1, Days 5, 12 and 14 PI(M1) = Post Dose 1, Month 1 PI(M6) = Post Dose 1, Month 6 PII(D2, 5, 8, 12) = Post Dose 2, Days 2, 5, 8 and 12 PII(D5, 8, 12, 14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7 |
| Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | 31 days post-vaccination per dose | Incidence of abnormal dengue examination findings reported during the 31-Day (Days 0-30) post-vaccination period, per dose |
| Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine | 0-21 days after dose 2 of study vaccine | Percentage of subjects with any adverse events (AEs) solicited and unsolicited reported during the 21-day post-vaccination period following dose 2 |
| Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | post dose 1 and 2 | Percentage of subject with Tetravalent responses for neutralizing antibodies, according to pre-vaccination dengue immune status. There was no placebo run for DEN Monovalent. PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7 |
| Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | 9 months | Seropositivity rates for neut. antibodies according to pre-vaccination flavivirus immune status-primed/unprimed subjects. PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7 PII(M9) = Post Dose 2, Month 9 |
| Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | within 7 months | Percentage of subjects with incidence of measurable dengue viremia at specified time points after each dose. Negative = GEQ/uL results is equal to zero Undetermined = GEQ/uL result is below LOD Positive = GEQ/uL result is \>=LOD Missing = No data PI(M1) = Post Dose 1, Month 1 PII(D2,5,8,12) = Post Dose 2, Days 2, 5,8 and 12 PII(D5,8,12,14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7 |
| Incidence of Suspected and Confirmed Dengue Throughout the Entire Study Period. | 9 months | Number of subjects with incidence of suspected and confirmed dengue throughout the entire study period. |
| Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose | 0-30 days after each study vaccine dose | Incidence of unsolicited AEs reported within the 31-day (Days 0-30) post-vaccination period for each study vaccine |
Countries
Thailand
Participant flow
Recruitment details
A total of 120 subjects were enrolled in study
Participants by arm
| Arm | Count |
|---|---|
| T-DEN F17 Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months. | 40 |
| T-DEN F19 Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months. | 40 |
| Placebo Comparator 0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months. | 40 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | Moved from area | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | T-DEN F17 | T-DEN F19 | Placebo Comparator | Total |
|---|---|---|---|---|
| Age, Continuous | 21.2 years STANDARD_DEVIATION 1.09 | 21.7 years STANDARD_DEVIATION 1.27 | 21.9 years STANDARD_DEVIATION 1.19 | 21.6 years STANDARD_DEVIATION 1.21 |
| Race/Ethnicity, Customized Asian - Southeast Asian heritage | 40 Participants | 40 Participants | 40 Participants | 120 Participants |
| Region of Enrollment Thailand | 40 Participants | 40 Participants | 40 Participants | 120 Participants |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 22 Participants | 68 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants | 18 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 39 / 40 | 34 / 40 | 35 / 40 |
| serious Total, serious adverse events | 0 / 40 | 2 / 40 | 1 / 40 |
Outcome results
Primary
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month)
Time frame: 0-21 days after dose 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Fatigue | 2.5 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Swelling | 0.0 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Pain behind eyes | 0.0 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Fever | 2.5 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Redness | 0.0 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Nausea | 2.5 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Headache | 2.5 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Pruritus | 2.5 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Mucsle Aches | 0.0 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Abdominal Pain | 0.0 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Vomiting | 0.0 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Pain | 0.0 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Arthralgia | 0.0 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Rash | 5.0 percentage of subjects |
| T-DEN F17 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Photophobia | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Photophobia | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Pain | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Redness | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Swelling | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Abdominal Pain | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Arthralgia | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Fatigue | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Fever | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Headache | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Mucsle Aches | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Nausea | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Pain behind eyes | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Pruritus | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Rash | 0.0 percentage of subjects |
| T-DEN F19 | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Vomiting | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Fatigue | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Rash | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Pain behind eyes | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Arthralgia | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Abdominal Pain | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Photophobia | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Swelling | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Pain | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Pruritus | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Headache | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Redness | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Mucsle Aches | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Fever | 2.5 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Vomiting | 0.0 percentage of subjects |
| Placebo Comparator | Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 | Nausea | 0.0 percentage of subjects |
Primary
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
Neutralizing antibody geometric mean titer (GMT) to DEN types 1, 2, 3 and 4 will be measured 30 and 90 days following the administration of the 2nd dose (6 month)
Time frame: 30 and 90 days after dose 2
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, Placebo | 152.3 GMTs |
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, F17 | 172.2 GMTs |
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, F19 | 412.6 GMTs |
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, Placebo | 412.9 GMTs |
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, F17 | 212.5 GMTs |
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, F19 | 278.2 GMTs |
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, Placebo | 180.3 GMTs |
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, F17 | 117.5 GMTs |
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, F19 | 241.6 GMTs |
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, Placebo | 302.2 GMTs |
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, F17 | 113.7 GMTs |
| T-DEN F17 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, F19 | 149.8 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, Placebo | 447.8 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, Placebo | 289.5 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, F19 | 772.4 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, F17 | 450.2 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, F17 | 776.3 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, F19 | 787.9 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, F19 | 1111.8 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, F19 | 1123.7 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, F17 | 860.7 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, F17 | 668.7 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, Placebo | 158.0 GMTs |
| T-DEN F19 | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, Placebo | 207.4 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, F19 | 695.5 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, F17 | 745.2 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, F17 | 1085.3 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, F19 | 1274.5 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, Placebo | 216.1 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, F17 | 507.7 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, Placebo | 441.8 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, F19 | 836.2 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, Placebo | 266.0 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, F17 | 958.0 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, Placebo | 178.7 GMTs |
| Placebo Comparator | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, F19 | 1233.4 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, Placebo | 449.2 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, Placebo | 178.4 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, Placebo | 384.7 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, F19 | 1334.1 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, F19 | 1061.1 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-1, F17 | 788.2 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, F17 | 1168.7 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, F17 | 519.3 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, F17 | 673.3 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-3, F19 | 730.3 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-4, F19 | 705.4 GMTs |
| PII (M9) | Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2 | DEN-2, Placebo | 231.1 GMTs |
Secondary
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Incidence of abnormal dengue examination findings reported during the 31-Day (Days 0-30) post-vaccination period, per dose
Time frame: 31 days post-vaccination per dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Hepatomegaly | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Rash | 5.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Conunctival hemorrhage | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Generalized rash | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Skin hemorrhage | 2.5 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Generalized rash | 5.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Generalized lymphadenopathy | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Splenomegaly | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Splenomegaly | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Conjunctival injection | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Conjunctival hemorrhage | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Rash | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Hepatomegaly | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Skin hemorrhage | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Mucosal hemorrhage | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Lymphadenopathy | 20.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Generalized lymphadenopathy | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Lymphadenopathy | 7.5 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Mucosal hemorrhage | 0.0 % of subjects |
| T-DEN F17 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Conjunctival injection | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Rash | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Conunctival hemorrhage | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Conjunctival injection | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Generalized lymphadenopathy | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Generalized rash | 5.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Hepatomegaly | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Lymphadenopathy | 25.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Mucosal hemorrhage | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Rash | 5.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Skin hemorrhage | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Splenomegaly | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Conjunctival hemorrhage | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Conjunctival injection | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Generalized lymphadenopathy | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Generalized rash | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Hepatomegaly | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Lymphadenopathy | 5.3 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Mucosal hemorrhage | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Skin hemorrhage | 0.0 % of subjects |
| T-DEN F19 | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Splenomegaly | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Conjunctival injection | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Generalized rash | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Mucosal hemorrhage | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Splenomegaly | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Hepatomegaly | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Lymphadenopathy | 25.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Skin hemorrhage | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Lymphadenopathy | 5.1 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Hepatomegaly | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Conunctival hemorrhage | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Mucosal hemorrhage | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Generalized rash | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Conjunctival hemorrhage | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Splenomegaly | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Generalized lymphadenopathy | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Conjunctival injection | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Skin hemorrhage | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Rash | 5.1 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 2 - Generalized lymphadenopathy | 0.0 % of subjects |
| Placebo Comparator | Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose | Dose 1 - Rash | 0.0 % of subjects |
Secondary
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
Percentage of subjects with incidence of measurable dengue viremia at specified time points after each dose. Negative = GEQ/uL results is equal to zero Undetermined = GEQ/uL result is below LOD Positive = GEQ/uL result is \>=LOD Missing = No data PI(M1) = Post Dose 1, Month 1 PII(D2,5,8,12) = Post Dose 2, Days 2, 5,8 and 12 PII(D5,8,12,14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7
Time frame: within 7 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Negative | 97.4 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Positive | 2.6 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Negative | 97.4 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Undetermined | 2.6 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Undetermined | 2.6 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Negative | 97.4 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Positive | 2.6 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Negative | 97.4 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Undetermined | 7.7 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Negative | 92.3 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Negative | 97.4 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Undetermined | 2.6 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Positive | 2.6 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Undetermined | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Undetermined | 2.6 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Negative | 94.7 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Undetermined | 2.6 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Negative | 97.4 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Negative | 100 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Positive | 0.0 % of subjects |
| T-DEN F17 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Negative | 97.4 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Negative | 97.4 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Positive | 2.6 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Positive | 2.6 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Undetermined | 5.1 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Negative | 92.3 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Undetermined | 2.6 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Negative | 97.4 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Undetermined | 2.9 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Negative | 97.1 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Undetermined | 2.6 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Undetermined | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Positive | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Negative | 100 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Missing | 0.0 % of subjects |
| T-DEN F19 | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Negative | 97.4 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(M1): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(M7): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(D5,8,12, 14): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Positive | 2.6 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Negative | 97.4 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PII(M7): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PI(M1): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Undetermined | 2.6 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Negative | 97.4 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(D5,8,12,14): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Undetermined | 2.6 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-2, RNA - PII(M7): Negative | 97.4 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PI(M1): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-3, RNA - PII(D5,8,12,14): Undetermined | 2.6 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(D5,12,14): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PI(M1): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D2,5,8,12): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(D5,8,12,14): Missing | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Positive | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Undetermined | 0.0 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-4, RNA - PII(M7): Negative | 100 % of subjects |
| Placebo Comparator | Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose | DEN-1, RNA - PI(D2,5,8,12): Missing | 0.0 % of subjects |
Secondary
Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period
Number of subjects experiencing serious adverse events (SAEs) throughout the entire 9 month study period
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T-DEN F17 | Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period | 0 Participants |
| T-DEN F19 | Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period | 2 Participants |
| Placebo Comparator | Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period | 1 Participants |
Secondary
Incidence of Suspected and Confirmed Dengue Throughout the Entire Study Period.
Number of subjects with incidence of suspected and confirmed dengue throughout the entire study period.
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| T-DEN F17 | Incidence of Suspected and Confirmed Dengue Throughout the Entire Study Period. | 0 Participants |
| T-DEN F19 | Incidence of Suspected and Confirmed Dengue Throughout the Entire Study Period. | 0 Participants |
| Placebo Comparator | Incidence of Suspected and Confirmed Dengue Throughout the Entire Study Period. | 0 Participants |
Secondary
Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose
Incidence of unsolicited AEs reported within the 31-day (Days 0-30) post-vaccination period for each study vaccine
Time frame: 0-30 days after each study vaccine dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-DEN F17 | Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose | 51 unsolicited AEs |
| T-DEN F19 | Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose | 34 unsolicited AEs |
| Placebo Comparator | Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose | 38 unsolicited AEs |
Secondary
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Laboratory valuesabove the alert values within 31 days (days 0-30) after each vaccine dose. Change from baseline in hematological and biochemical levels with respect to normal ranges. PI(D2, 5, 8, 12) = Post Dose 1, Days 2, 5, 8 and 12 PI(D5, 12,14) = Post Dose 1, Days 5, 12 and 14 PI(M1) = Post Dose 1, Month 1 PI(M6) = Post Dose 1, Month 6 PII(D2, 5, 8, 12) = Post Dose 2, Days 2, 5, 8 and 12 PII(D5, 8, 12, 14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7
Time frame: within 31 days after each vaccine dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(D5,12,14) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | ALT - PI(D5,12,14) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PII(D2,5,8,12) | 1 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(M6) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PII(D5,8,12,14) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PII(D5,8,12,14) | 1 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(M1) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PII(D2,5,8,12) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PII(M7) | 1 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | ALT - PI(D2,5,8,12) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Haemato-Crit - Any point | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(D2,5,8,12) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | ALT - PI(M1) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(D2,5,8,12) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PII(D5,8,12,14) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(D5,12,14) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(D5,12,14) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(M1) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PII(M7) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(M1) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PII(M7) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(D2,5,8,12) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(M6) | 0 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(M6) | 1 subjects |
| T-DEN F17 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PII(D2,5,8,12) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(D2,5,8,12) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PII(D2,5,8,12) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PII(D5,8,12,14) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PII(M7) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(D5,12,14) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(D2,5,8,12) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | ALT - PI(D2,5,8,12) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(M6) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PII(D2,5,8,12) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(M1) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PII(D5,8,12,14) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PII(M7) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(M6) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PII(D2,5,8,12) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | ALT - PI(D5,12,14) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PII(D5,8,12,14) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(M1) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PII(M7) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Haemato-Crit - Any point | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(D2,5,8,12) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | ALT - PI(M1) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(D5,12,14) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(D5,12,14) | 1 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(M1) | 0 subjects |
| T-DEN F19 | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(M6) | 1 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PII(M7) | 2 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(D5,12,14) | 2 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(M1) | 2 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | ALT - PI(D2,5,8,12) | 1 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | ALT - PI(D5,12,14) | 1 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | ALT - PI(M1) | 1 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(D2,5,8,12) | 0 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(D5,12,14) | 0 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(M1) | 0 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PI(M6) | 0 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PII(D2,5,8,12) | 0 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PII(D5,8,12,14) | 0 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Haemato-Crit - Any point | 0 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(D2,5,8,12) | 1 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(D5,12,14) | 1 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(M1) | 1 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PI(M6) | 1 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PII(D2,5,8,12) | 1 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PII(D5,8,12,14) | 1 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Neutro-Phil Count - PII(M7) | 1 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(D2,5,8,12) | 2 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PI(M6) | 2 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PII(D2,5,8,12) | 2 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | Platelets - PII(D5,8,12,14) | 2 subjects |
| Placebo Comparator | Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose | AST - PII(M7) | 0 subjects |
Secondary
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
Seropositivity rates for neut. antibodies according to pre-vaccination flavivirus immune status-primed/unprimed subjects. PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7 PII(M9) = Post Dose 2, Month 9
Time frame: 9 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PII(M7) | 97.4 % of subjects |
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PII(M9) | 100 % of subjects |
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PRE | 76.9 % of subjects |
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PI(M1) | 89.7 % of subjects |
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PII(M7) | 100 % of subjects |
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PI(M1) | 92.3 % of subjects |
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PRE | 76.9 % of subjects |
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PI(M1) | 87.2 % of subjects |
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PII(M7) | 100 % of subjects |
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PII(M9) | 94.9 % of subjects |
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PRE | 71.8 % of subjects |
| T-DEN F17 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PII(M9) | 94.9 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PI(M1) | 100 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PRE | 87.2 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PI(M1) | 100 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PII(M7) | 100 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PII(M9) | 100 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PRE | 82.1 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PII(M9) | 97.2 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PII(M7) | 100 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PII(M9) | 100 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PRE | 82.1 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PI(M1) | 100 % of subjects |
| T-DEN F19 | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PII(M7) | 100 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PRE | 87.5 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PII(M9) | 89.7 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PII(M7) | 87.2 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PII(M9) | 89.7 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PRE | 85.0 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PI(M1) | 87.5 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PII(M7) | 87.2 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PI(M1) | 87.5 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PRE | 87.5 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-3, >10 ED50 - PI(M1) | 87.5 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-2, >10 ED50 - PII(M7) | 87.2 % of subjects |
| Placebo Comparator | Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines | DEN-1, >10 ED50 - PII(M9) | 89.7 % of subjects |
Secondary
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
Percentage of subject with Tetravalent responses for neutralizing antibodies, according to pre-vaccination dengue immune status. There was no placebo run for DEN Monovalent. PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7
Time frame: post dose 1 and 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-DEN F17 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Multivalent - PII(M7) | 100 % of subjects |
| T-DEN F17 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Unprimed - PRE | 0.00 % of subjects |
| T-DEN F17 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Monovalent - PRE | 0.00 % of subjects |
| T-DEN F17 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Multivalent - PI(M1) | 100 % of subjects |
| T-DEN F17 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Unprimed - PI(M1) | 20.00 % of subjects |
| T-DEN F17 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Monovalent - PI(M1) | 75.00 % of subjects |
| T-DEN F17 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Monovalent - PII(M7) | 75.00 % of subjects |
| T-DEN F17 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Unprimed - PII(M7) | 100 % of subjects |
| T-DEN F17 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Multivalent - PRE | 86.67 % of subjects |
| T-DEN F19 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Unprimed - PI(M1) | 100 % of subjects |
| T-DEN F19 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Multivalent - PRE | 90.91 % of subjects |
| T-DEN F19 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Unprimed - PRE | 0.00 % of subjects |
| T-DEN F19 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Multivalent - PI(M1) | 100 % of subjects |
| T-DEN F19 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Multivalent - PII(M7) | 100 % of subjects |
| T-DEN F19 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Monovalent - PI(M1) | 100 % of subjects |
| T-DEN F19 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Unprimed - PII(M7) | 100 % of subjects |
| T-DEN F19 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Monovalent - PRE | 0.00 % of subjects |
| T-DEN F19 | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Monovalent - PII(M7) | 100 % of subjects |
| Placebo Comparator | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Multivalent - PII(M7) | 100 % of subjects |
| Placebo Comparator | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Monovalent - PI(M1) | 0.00 % of subjects |
| Placebo Comparator | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Unprimed - PRE | 0.00 % of subjects |
| Placebo Comparator | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Unprimed - PI(M1) | 0.00 % of subjects |
| Placebo Comparator | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Unprimed - PII(M7) | 0.00 % of subjects |
| Placebo Comparator | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Monovalent - PRE | 0.00 % of subjects |
| Placebo Comparator | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Monovalent - PII(M7) | 0.00 % of subjects |
| Placebo Comparator | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Multivalent - PRE | 97.14 % of subjects |
| Placebo Comparator | Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines | DEN Multivalent - PI(M1) | 97.14 % of subjects |
Secondary
Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine
Percentage of subjects with any adverse events (AEs) solicited and unsolicited reported during the 21-day post-vaccination period following dose 2
Time frame: 0-21 days after dose 2 of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-DEN F17 | Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine | General symptoms | 71.8 percentage of subjects |
| T-DEN F17 | Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine | Any symptom | 74.4 percentage of subjects |
| T-DEN F17 | Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine | All symptoms | 51.3 percentage of subjects |
| T-DEN F19 | Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine | General symptoms | 54.3 percentage of subjects |
| T-DEN F19 | Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine | Any symptom | 65.7 percentage of subjects |
| T-DEN F19 | Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine | All symptoms | 31.4 percentage of subjects |
| Placebo Comparator | Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine | Any symptom | 64.1 percentage of subjects |
| Placebo Comparator | Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine | All symptoms | 23.1 percentage of subjects |
| Placebo Comparator | Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine | General symptoms | 53.8 percentage of subjects |