Dengue Fever, Dengue Hemorrhagic Fever, Dengue Shock Syndrome
Conditions
Keywords
Dengue, Virus, Live-attenuated, Vaccine, Dengue viral infection, Dengue Vaccine
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of two different formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two doses are given six months apart to adults and children.
Detailed description
In this study, children and adults at multiple sites in Puerto Rico will be randomly allocated to receive one of two T-DEN formulations or placebo. Subjects will be stratified by age group (a specific number of subjects in each of 4 age groups \[12 months to 50 years of age\] will be enrolled). The study includes 6 scheduled visits and 4 scheduled venipunctures. Safety follow-up for dengue may require unscheduled visits and venipunctures.\> Multiple DEN virus serotypes are endemic in Puerto Rico and all residents are considered to be at risk for dengue. The results of this phase II study will provide a basis for identifying the vaccine formulations which elicit neutralizing antibodies to all four dengue virus serotypes in a high proportion of vaccine recipients. The most immunogenic and well tolerated candidate formulation identified in this study will be considered for advancement to phase III development.\>
Interventions
OTHERPlacebo
Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months
BIOLOGICALT-DEN-Post-Transfection F17
Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
BIOLOGICALT-DEN-Post-Transfection F19
Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
Sponsors
GlaxoSmithKline
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Months to 50 Years
Healthy volunteers
Yes
Inclusion criteria
\> * Subjects who the investigator believes that they and/or their parents/guardians 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.\> * A healthy male or non-pregnant female between 12 months (mths) and 50 years (yrs) of age at the time of the first vaccination;\> * Free of obvious health problems as established by medical history and physical examination before entering into the study;\> * For children: 23mths of age, full compliance with the United States Advisory Committee on Immunization Practices (U.S. ACIP) recommended childhood immunization schedule;\> * Written informed consent obtained from the subject or a parent/guardian and assent for subjects 7-20 yrs of age;\> * If the subject is female, she must be of non-childbearing potential, i.e. either pre-menarcheal, surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; condom and spermicide combination, oral contraceptives or other equivalent hormonal contraception, e.g. progestin implantable, cutaneous hormonal patch or injectable contraceptives) for 30 days (dys) prior to vaccination, have a negative pregnancy test within 48 hrs prior to vaccination and must agree to continue such precautions for 60 dys after completion of the vaccination series. Any child who begins menarche during the study period must follow the same precautions listed above, from menarche until 60 dys after the second vaccine dose.\>
Exclusion criteria
\> * Pregnant or lactating female;\> * 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 allergic disease/reaction likely to be exacerbated by any component of the vaccine;\> * Acute or chronic, clinically significant 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;\> * Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever); note that vaccine can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., equivalent to an oral temperature \<37.5°C/\<99.5°F.\> * Chronic hepatomegaly, right upper quadrant abdominal pain or tenderness;\> * Chronic splenomegaly, left upper quadrant abdominal pain or tenderness;\> * Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 dys preceding the first dose of study vaccine/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 dys before each dose of the study vaccine and ending 30 dys after; with the exception of standard infant and children inactivated vaccines or the inactivated influenza vaccine administered to adults or children; \> * A planned move to a location that will prohibit participating in the trial for the 12 mth duration;\> * Chronic administration (defined as more than 14 dys) of immunosuppressants or other immune-modifying drugs within 90 dys 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 dys preceding the first dose or planned administration during the study period;\> * Hypertension;\> * Chest pain, palpitations, dizziness, shortness of breath unrelated to asthma, arrhythmias or friction rubs;\> * Any chronic systemic drug therapy to be continued during the study period (except for vitamin/mineral supplements, routine treatment for gastro-esophageal reflux);\> * Potential adult volunteers, or parents of potential child volunteers, who do not have easy access to a fixed or mobile telephone;\> * History of chronic alcohol consumption and/or drug abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Within 21 days (days 0-20) f/up period after each vaccine dose | Incidence of all and grade 3 (prevents normal, everyday activities) solicited local and general symptoms within the 21-day follow-up period (Total vaccinated cohort) |
| Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period | Within the 31-day (days 0-30) follow-up period after each vaccine dose | Summary of unsolicited Adverse Events within the 31-day post-vaccination period by age group (total vaccinated cohort) |
| Safety: Occurrence of Serious Adverse Events (SAEs) | 6 months + 30 day follow-up period after last vaccine dose | Summary of SAEs, 6 months + 30 day follow-up period after last vaccine dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Pre-accination, at post dose 1, months 3 and 6 and post dose 2, month 7 | Seropositivity rates for DEN neut. antibodies for unprimed and primed subjects |
| Incidence of Suspected and Laboratory Confirmed Dengue | 31-day (days 0-30) post-vaccination period and after 31-day period | Incidence of suspected and confirmed dengue reported during the 31-day (Days 0-30) post-vaccination period and after the 31-day period |
| Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | at month 7, post dose 2 | Vaccine response for DEN-1, DEN2, DEN-3, DEN-4 antibody at post dose 2, month 7 |
| Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | at month 3, post dose 1 | Vaccine response for DEN-1, DEN-2, DEN-3 and DEN-4 antibody S- = seronegative subjects (antibody titer \<10 ED50 for DEN-1, 2, 3, and 4 prior to vaccination; S+ = Seropositive subjects (antibody titer \>10 ED50 for DEN-1, 2, 3 and 4 prior to vaccination; Total = subjects either seropositive or seronegative at pre-vaccination Vaccine response defined as: For initially seronegative subjects, antibody titer \>10 ED50 at PI(M3) and for initially seropositive subjects: antibody titer at PI(m3) \>4 fold the pre-vaccination antibody titer |
| GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | at month 7 (one month post dose 2) | Comparison of F17 and F19 formulations in terms of GMTs at month 7 (one month post dose 2) for each DEN type, -unprimed and primed subjects |
| Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Pre-vaccination, at post dose 1, months 3 and 6 and post dose 2, month 7 | Monovalent, bivalent, trivalent and tetravalent response for DEN neut. antibodies for unprimed and primed subjects |
Countries
Puerto Rico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T-DEN-Post-Transfection F17 Post-Transfection F17, full dose
T-DEN-Post-Transfection F17: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months | 211 |
| T-DEN-Post-Transfection F19 Post-Transfection F19, full dose
T-DEN-Post-Transfection F19: Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months | 212 |
| Placebo Control
Placebo: Lyophilized, single dose vials and sterile water for
\> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months | 213 |
| Total | 636 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 5 |
| Overall Study | Other | 0 | 0 | 1 |
| Overall Study | Relocation | 1 | 3 | 3 |
| Overall Study | Withdrawal by Subject | 7 | 4 | 5 |
Baseline characteristics
| Characteristic | T-DEN-Post-Transfection F17 | T-DEN-Post-Transfection F19 | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 13.8 years STANDARD_DEVIATION 14.1 | 12.8 years STANDARD_DEVIATION 12.51 | 13.6 years STANDARD_DEVIATION 13.89 | 13.4 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 210 Participants | 212 Participants | 213 Participants | 635 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race African heritage / African American | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race American | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Dominican | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Hispanic | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Mixed | 9 Participants | 7 Participants | 10 Participants | 26 Participants |
| Race/Ethnicity, Customized Race Peruvian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Puerto Rican | 164 Participants | 166 Participants | 164 Participants | 494 Participants |
| Race/Ethnicity, Customized Race White-Arabic / North African heritage | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White - Caucasian / European heritage | 32 Participants | 34 Participants | 32 Participants | 98 Participants |
| Region of Enrollment Puerto Rico | 211 Participants | 212 Participants | 213 Participants | 636 Participants |
| Sex: Female, Male Female | 107 Participants | 114 Participants | 114 Participants | 335 Participants |
| Sex: Female, Male Male | 104 Participants | 98 Participants | 99 Participants | 301 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 211 | 0 / 212 | 0 / 213 |
| other Total, other adverse events | 90 / 211 | 93 / 212 | 93 / 213 |
| serious Total, serious adverse events | 8 / 211 | 4 / 212 | 11 / 213 |
Outcome results
Primary
Safety: Incidence of All and Grade 3 Solicited Local Symptoms
Incidence of all and grade 3 (prevents normal, everyday activities) solicited local and general symptoms within the 21-day follow-up period (Total vaccinated cohort)
Time frame: Within 21 days (days 0-20) f/up period after each vaccine dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Abdominal Pain - All | 28 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | All Grade 3 AEs | 114 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Headache - Grade 3 | 3 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Abdominal Pain - Grade 3 | 0 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Redness - All | 31 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Headache - All | 75 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fatigue - All | 28 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Vomiting - Grade 3 | 0 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fever - Grade 3 | 10 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fatigue - Grade 3 | 0 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Rash - Grade 3 | 0 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fever - All | 103 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Redness - Grade 3 | 6 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Vomiting - All | 24 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Rash - All | 18 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Swelling - All | 3 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pain - Grade 3 | 1 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pruritus - Grade 3 | 0 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Swelling - Grade 3 | 3 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pain - All | 55 number of occurances |
| T-DEN-Post-Transfection F17 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pruritus - All | 25 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Rash - Grade 3 | 0 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | All Grade 3 AEs | 98 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pain - All | 60 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pain - Grade 3 | 0 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Redness - All | 22 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Redness - Grade 3 | 2 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Swelling - All | 14 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Swelling - Grade 3 | 0 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Abdominal Pain - All | 39 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Abdominal Pain - Grade 3 | 1 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fatigue - All | 33 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fatigue - Grade 3 | 1 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fever - All | 100 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fever - Grade 3 | 13 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Headache - All | 73 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Headache - Grade 3 | 1 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pruritus - All | 27 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pruritus - Grade 3 | 0 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Rash - All | 20 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Vomiting - All | 26 number of occurances |
| T-DEN-Post-Transfection F19 | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Vomiting - Grade 3 | 1 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Abdominal Pain - All | 28 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pain - All | 48 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Headache - Grade 3 | 6 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Swelling - Grade 3 | 1 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Vomiting - Grade 3 | 1 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pruritus - All | 19 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Swelling - All | 10 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Vomiting - All | 21 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pruritus - Grade 3 | 1 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Redness - Grade 3 | 5 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | All Grade 3 AEs | 84 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Rash - All | 10 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fatigue - Grade 3 | 0 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Redness - All | 20 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fever - All | 83 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fatigue - All | 32 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Pain - Grade 3 | 0 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Fever - Grade 3 | 9 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Abdominal Pain - Grade 3 | 1 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Rash - Grade 3 | 1 number of occurances |
| Placebo | Safety: Incidence of All and Grade 3 Solicited Local Symptoms | Headache - All | 72 number of occurances |
Primary
Safety: Occurrence of Serious Adverse Events (SAEs)
Summary of SAEs, 6 months + 30 day follow-up period after last vaccine dose
Time frame: 6 months + 30 day follow-up period after last vaccine dose
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| T-DEN-Post-Transfection F17 | Safety: Occurrence of Serious Adverse Events (SAEs) | Subject showing no SAE symptoms | 203 Participants |
| T-DEN-Post-Transfection F17 | Safety: Occurrence of Serious Adverse Events (SAEs) | Subjects with at least 1 SAE - not related | 8 Participants |
| T-DEN-Post-Transfection F17 | Safety: Occurrence of Serious Adverse Events (SAEs) | Subjects with at least 1 SAE - related | 0 Participants |
| T-DEN-Post-Transfection F19 | Safety: Occurrence of Serious Adverse Events (SAEs) | Subject showing no SAE symptoms | 208 Participants |
| T-DEN-Post-Transfection F19 | Safety: Occurrence of Serious Adverse Events (SAEs) | Subjects with at least 1 SAE - not related | 4 Participants |
| T-DEN-Post-Transfection F19 | Safety: Occurrence of Serious Adverse Events (SAEs) | Subjects with at least 1 SAE - related | 0 Participants |
| Placebo | Safety: Occurrence of Serious Adverse Events (SAEs) | Subjects with at least 1 SAE - not related | 11 Participants |
| Placebo | Safety: Occurrence of Serious Adverse Events (SAEs) | Subjects with at least 1 SAE - related | 0 Participants |
| Placebo | Safety: Occurrence of Serious Adverse Events (SAEs) | Subject showing no SAE symptoms | 202 Participants |
Primary
Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period
Summary of unsolicited Adverse Events within the 31-day post-vaccination period by age group (total vaccinated cohort)
Time frame: Within the 31-day (days 0-30) follow-up period after each vaccine dose
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| T-DEN-Post-Transfection F17 | Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period | At least one symptom - age 5 - 50 | 44 Participants |
| T-DEN-Post-Transfection F17 | Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period | At least one symptom - age 1 - 4 years | 52 Participants |
| T-DEN-Post-Transfection F17 | Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period | Subject showing no unsolicited symptoms | 115 Participants |
| T-DEN-Post-Transfection F19 | Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period | At least one symptom - age 5 - 50 | 40 Participants |
| T-DEN-Post-Transfection F19 | Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period | At least one symptom - age 1 - 4 years | 60 Participants |
| T-DEN-Post-Transfection F19 | Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period | Subject showing no unsolicited symptoms | 112 Participants |
| Placebo | Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period | At least one symptom - age 1 - 4 years | 65 Participants |
| Placebo | Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period | Subject showing no unsolicited symptoms | 108 Participants |
| Placebo | Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period | At least one symptom - age 5 - 50 | 40 Participants |
Secondary
GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects
Comparison of F17 and F19 formulations in terms of GMTs at month 7 (one month post dose 2) for each DEN type, -unprimed and primed subjects
Time frame: at month 7 (one month post dose 2)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| T-DEN-Post-Transfection F17 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Unprimed Subjects: DEN-1 | 130.9 titers |
| T-DEN-Post-Transfection F17 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Unprimed Subjects: DEN-2 | 218.6 titers |
| T-DEN-Post-Transfection F17 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Unprimed Subjects: DEN-3 | 124.5 titers |
| T-DEN-Post-Transfection F17 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Unprimed Subjects: DEN-4 | 377.7 titers |
| T-DEN-Post-Transfection F17 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Primed Subjects: DEN-1 | 1412.8 titers |
| T-DEN-Post-Transfection F17 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Primed Subjects: DEN-2 | 1514.4 titers |
| T-DEN-Post-Transfection F17 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Primed Subjects: DEN-3 | 1130.0 titers |
| T-DEN-Post-Transfection F17 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Primed Subjects: DEN-4 | 1228.4 titers |
| T-DEN-Post-Transfection F19 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Primed Subjects: DEN-4 | 1020.8 titers |
| T-DEN-Post-Transfection F19 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Unprimed Subjects: DEN-1 | 84.4 titers |
| T-DEN-Post-Transfection F19 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Primed Subjects: DEN-1 | 1324.1 titers |
| T-DEN-Post-Transfection F19 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Unprimed Subjects: DEN-2 | 215.2 titers |
| T-DEN-Post-Transfection F19 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Primed Subjects: DEN-3 | 901.4 titers |
| T-DEN-Post-Transfection F19 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Unprimed Subjects: DEN-3 | 60.3 titers |
| T-DEN-Post-Transfection F19 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Primed Subjects: DEN-2 | 1338.5 titers |
| T-DEN-Post-Transfection F19 | GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects | Unprimed Subjects: DEN-4 | 105.9 titers |
Secondary
Incidence of Suspected and Laboratory Confirmed Dengue
Incidence of suspected and confirmed dengue reported during the 31-day (Days 0-30) post-vaccination period and after the 31-day period
Time frame: 31-day (days 0-30) post-vaccination period and after 31-day period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-DEN-Post-Transfection F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected with med. attention | 3 dengue fever cases |
| T-DEN-Post-Transfection F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Confirmed dengue fever | 0 dengue fever cases |
| T-DEN-Post-Transfection F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Confirmed dengue fever | 0 dengue fever cases |
| T-DEN-Post-Transfection F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Confirmed dengue fever | 0 dengue fever cases |
| T-DEN-Post-Transfection F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected dengue fever | 3 dengue fever cases |
| T-DEN-Post-Transfection F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected with med. attention | 0 dengue fever cases |
| T-DEN-Post-Transfection F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected with med. attention | 3 dengue fever cases |
| T-DEN-Post-Transfection F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected dengue fever | 3 dengue fever cases |
| T-DEN-Post-Transfection F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected dengue fever | 0 dengue fever cases |
| T-DEN-Post-Transfection F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Confirmed dengue fever | 0 dengue fever cases |
| T-DEN-Post-Transfection F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Confirmed dengue fever | 0 dengue fever cases |
| T-DEN-Post-Transfection F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected with med. attention | 3 dengue fever cases |
| T-DEN-Post-Transfection F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Confirmed dengue fever | 0 dengue fever cases |
| T-DEN-Post-Transfection F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected dengue fever | 3 dengue fever cases |
| T-DEN-Post-Transfection F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected with med. attention | 4 dengue fever cases |
| T-DEN-Post-Transfection F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected dengue fever | 1 dengue fever cases |
| T-DEN-Post-Transfection F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected dengue fever | 4 dengue fever cases |
| T-DEN-Post-Transfection F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected with med. attention | 1 dengue fever cases |
| Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected with med. attention | 0 dengue fever cases |
| Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Confirmed dengue fever | 0 dengue fever cases |
| Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected dengue fever | 1 dengue fever cases |
| Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected with med. attention | 1 dengue fever cases |
| Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Confirmed dengue fever | 0 dengue fever cases |
| Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Confirmed dengue fever | 0 dengue fever cases |
| Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected dengue fever | 1 dengue fever cases |
| Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected with med. attention | 1 dengue fever cases |
| Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected dengue fever | 0 dengue fever cases |
| After 31-Day Post Vaccination Period: F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Confirmed dengue fever | 0 dengue fever cases |
| After 31-Day Post Vaccination Period: F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected dengue fever | 3 dengue fever cases |
| After 31-Day Post Vaccination Period: F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected with med. attention | 3 dengue fever cases |
| After 31-Day Post Vaccination Period: F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Confirmed dengue fever | 0 dengue fever cases |
| After 31-Day Post Vaccination Period: F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected dengue fever | 1 dengue fever cases |
| After 31-Day Post Vaccination Period: F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected with med. attention | 1 dengue fever cases |
| After 31-Day Post Vaccination Period: F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected dengue fever | 4 dengue fever cases |
| After 31-Day Post Vaccination Period: F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected with med. attention | 4 dengue fever cases |
| After 31-Day Post Vaccination Period: F17 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Confirmed dengue fever | 0 dengue fever cases |
| After 31-Day Post Vaccination Period: F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected with med. attention | 1 dengue fever cases |
| After 31-Day Post Vaccination Period: F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected dengue fever | 1 dengue fever cases |
| After 31-Day Post Vaccination Period: F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected dengue fever | 4 dengue fever cases |
| After 31-Day Post Vaccination Period: F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Confirmed dengue fever | 0 dengue fever cases |
| After 31-Day Post Vaccination Period: F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Confirmed dengue fever | 0 dengue fever cases |
| After 31-Day Post Vaccination Period: F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected with med. attention | 4 dengue fever cases |
| After 31-Day Post Vaccination Period: F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected with med. attention | 3 dengue fever cases |
| After 31-Day Post Vaccination Period: F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected dengue fever | 3 dengue fever cases |
| After 31-Day Post Vaccination Period: F19 | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Confirmed dengue fever | 0 dengue fever cases |
| After 31-Day Post-Vaccination Period: Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected dengue fever | 3 dengue fever cases |
| After 31-Day Post-Vaccination Period: Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected dengue fever | 0 dengue fever cases |
| After 31-Day Post-Vaccination Period: Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Confirmed dengue fever | 0 dengue fever cases |
| After 31-Day Post-Vaccination Period: Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Confirmed dengue fever | 0 dengue fever cases |
| After 31-Day Post-Vaccination Period: Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected with med. attention | 3 dengue fever cases |
| After 31-Day Post-Vaccination Period: Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Overall Subject: Suspected dengue fever | 3 dengue fever cases |
| After 31-Day Post-Vaccination Period: Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Confirmed dengue fever | 0 dengue fever cases |
| After 31-Day Post-Vaccination Period: Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 2: Suspected with med. attention | 0 dengue fever cases |
| After 31-Day Post-Vaccination Period: Placebo | Incidence of Suspected and Laboratory Confirmed Dengue | Dose 1: Suspected with med. attention | 3 dengue fever cases |
Secondary
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes
Monovalent, bivalent, trivalent and tetravalent response for DEN neut. antibodies for unprimed and primed subjects
Time frame: Pre-vaccination, at post dose 1, months 3 and 6 and post dose 2, month 7
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 0 % of subjects |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 0 % of subjects |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 0 % of subjects |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 100 % of subjects |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 3.3 % of subjects |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 0 % of subjects |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 1.1 % of subjects |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 0 % of subjects |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 96.5 % of subjects |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 0 % of subjects |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 96.6 % of subjects |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 24.1 % of subjects |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 10.8 % of subjects |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 0 % of subjects |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 1.1 % of subjects |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 7.2 % of subjects |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 53 % of subjects |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 1.1 % of subjects |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 4.8 % of subjects |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 1.1 % of subjects |
| Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 9.8 % of subjects |
| Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 1.1 % of subjects |
| Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 0 % of subjects |
| Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 1.1 % of subjects |
| Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 52.4 % of subjects |
| Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 23.2 % of subjects |
| Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 97.7 % of subjects |
| Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 1.1 % of subjects |
| Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 7.3 % of subjects |
| Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 7.3 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 0 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 86.6 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 7.3 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 0 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 100 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 1.2 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 2.4 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 0 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 0 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 2.4 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 100 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 0 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 3.2 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 0 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 0 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 2.1 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 92.6 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 0 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 2.1 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 0 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 0 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 98.9 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 0 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 1.1 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 50 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 5 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 23.3 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 0 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 20 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 1.7 % of subjects |
| F19 PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 100 % of subjects |
| F19 PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 50.8 % of subjects |
| F19 PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 27.1 % of subjects |
| F19 PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 5.1 % of subjects |
| F19 PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 3.4 % of subjects |
| F19 PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 13.6 % of subjects |
| F19 PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 0 % of subjects |
| F19 PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 0 % of subjects |
| F19 PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 0 % of subjects |
| F19 PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 0 % of subjects |
| F19 PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 8.5 % of subjects |
| F19 PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 5.1 % of subjects |
| F19 PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 0 % of subjects |
| F19 PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 74.6 % of subjects |
| F19 PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 0 % of subjects |
| F19 PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 5.1 % of subjects |
| F19 PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 6.8 % of subjects |
| F19 PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 0 % of subjects |
| F19 PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 1.1 % of subjects |
| F19 PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 98.9 % of subjects |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 0 % of subjects |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 100 % of subjects |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 0 % of subjects |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 0 % of subjects |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 1 % of subjects |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 8.9 % of subjects |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 0 % of subjects |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 90.1 % of subjects |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 0 % of subjects |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 0 % of subjects |
| Placebo: PI (M3) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 3 % of subjects |
| Placebo: PI (M3) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 3 % of subjects |
| Placebo: PI (M3) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 0 % of subjects |
| Placebo: PI (M3) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 0 % of subjects |
| Placebo: PI (M3) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 0 % of subjects |
| Placebo: PI (M3) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 2 % of subjects |
| Placebo: PI (M3) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 0 % of subjects |
| Placebo: PI (M3) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 95.8 % of subjects |
| Placebo: PI (M3) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 91.9 % of subjects |
| Placebo: PI (M3) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 4.2 % of subjects |
| Placebo: PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 5.1 % of subjects |
| Placebo: PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 92.8 % of subjects |
| Placebo: PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 3 % of subjects |
| Placebo: PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 0 % of subjects |
| Placebo: PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 2 % of subjects |
| Placebo: PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 2.9 % of subjects |
| Placebo: PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 89.9 % of subjects |
| Placebo: PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 2.9 % of subjects |
| Placebo: PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 0 % of subjects |
| Placebo: PI (M6) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 1.4 % of subjects |
| Placebo: PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Monovalent | 2 % of subjects |
| Placebo: PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=None | 94.1 % of subjects |
| Placebo: PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Bivalent | 1 % of subjects |
| Placebo: PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Tetravalent | 2.9 % of subjects |
| Placebo: PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Trivalent | 0 % of subjects |
| Placebo: PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Monovalent | 1.5 % of subjects |
| Placebo: PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Trivalent | 1 % of subjects |
| Placebo: PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=Tetravalent | 90.9 % of subjects |
| Placebo: PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Primed: Valence=None | 5.1 % of subjects |
| Placebo: PII (M7) | Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes | Unprimed: Valence=Bivalent | 1.5 % of subjects |
Secondary
Percent of Subjects With Neut. Sero-response to Each DEN Serotype
Seropositivity rates for DEN neut. antibodies for unprimed and primed subjects
Time frame: Pre-accination, at post dose 1, months 3 and 6 and post dose 2, month 7
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 0.0 percent of subject with attribute |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 96.7 percent of subject with attribute |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 0 percent of subject with attribute |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 96.7 percent of subject with attribute |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 0.0 percent of subject with attribute |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 0.0 percent of subject with attribute |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 97.8 percent of subject with attribute |
| T-DEN-Post-Transfection F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 97.8 percent of subject with attribute |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 26.5 percent of subject with attribute |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 98.9 percent of subject with attribute |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 20.5 percent of subject with attribute |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 37.3 percent of subject with attribute |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 96.6 percent of subject with attribute |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 96.6 percent of subject with attribute |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 14.5 percent of subject with attribute |
| T-DEN-Post-Transfection F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 97.7 percent of subject with attribute |
| Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 98.9 percent of subject with attribute |
| Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 98.9 percent of subject with attribute |
| Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 22.0 percent of subject with attribute |
| Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 32.9 percent of subject with attribute |
| Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 15.9 percent of subject with attribute |
| Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 28.0 percent of subject with attribute |
| Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 97.7 percent of subject with attribute |
| Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 97.7 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 95.1 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 97.6 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 100 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 100 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 100 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 100 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 92.7 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F17 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 89.0 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 0.0 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 96.8 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 98.9 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 0.0 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 92.6 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 0.0 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 96.8 percent of subject with attribute |
| After 31-Day Post Vaccination Period: F19 | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 0.0 percent of subject with attribute |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 26.7 percent of subject with attribute |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 98.9 percent of subject with attribute |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 43.3 percent of subject with attribute |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 98.9 percent of subject with attribute |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 26.7 percent of subject with attribute |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 98.9 percent of subject with attribute |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 21.7 percent of subject with attribute |
| After 31-Day Post-Vaccination Period: Placebo | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 98.9 percent of subject with attribute |
| F19 PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 16.9 percent of subject with attribute |
| F19 PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 18.6 percent of subject with attribute |
| F19 PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 40.7 percent of subject with attribute |
| F19 PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 25.4 percent of subject with attribute |
| F19 PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 100 percent of subject with attribute |
| F19 PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 100 percent of subject with attribute |
| F19 PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 100 percent of subject with attribute |
| F19 PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 100 percent of subject with attribute |
| F19 PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 93.2 percent of subject with attribute |
| F19 PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 78.0 percent of subject with attribute |
| F19 PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 98.9 percent of subject with attribute |
| F19 PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 83.1 percent of subject with attribute |
| F19 PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 100 percent of subject with attribute |
| F19 PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 86.4 percent of subject with attribute |
| F19 PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 98.9 percent of subject with attribute |
| F19 PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 98.9 percent of subject with attribute |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 95.0 percent of subject with attribute |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 0.0 percent of subject with attribute |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 0.0 percent of subject with attribute |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 90.1 percent of subject with attribute |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 92.1 percent of subject with attribute |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 0.0 percent of subject with attribute |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 0.0 percent of subject with attribute |
| Placebo: Pre-vaccination | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 94.1 percent of subject with attribute |
| Placebo: PI (M3) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 4.2 percent of subject with attribute |
| Placebo: PI (M3) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 4.2 percent of subject with attribute |
| Placebo: PI (M3) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 4.2 percent of subject with attribute |
| Placebo: PI (M3) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 93.9 percent of subject with attribute |
| Placebo: PI (M3) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 91.9 percent of subject with attribute |
| Placebo: PI (M3) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 93.9 percent of subject with attribute |
| Placebo: PI (M3) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 94.9 percent of subject with attribute |
| Placebo: PI (M3) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 4.2 percent of subject with attribute |
| Placebo: PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 7.2 percent of subject with attribute |
| Placebo: PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 92.9 percent of subject with attribute |
| Placebo: PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 92.9 percent of subject with attribute |
| Placebo: PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 4.3 percent of subject with attribute |
| Placebo: PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 91.9 percent of subject with attribute |
| Placebo: PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 90.9 percent of subject with attribute |
| Placebo: PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 4.3 percent of subject with attribute |
| Placebo: PI (M6) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 2.9 percent of subject with attribute |
| Placebo: PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-1, >10 ED50 | 4.4 percent of subject with attribute |
| Placebo: PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-2, >10 ED50 | 2.9 percent of subject with attribute |
| Placebo: PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-4, >10 ED50 | 92.9 percent of subject with attribute |
| Placebo: PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-2, >10 ED50 | 93.9 percent of subject with attribute |
| Placebo: PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-4, >10 ED50 | 4.4 percent of subject with attribute |
| Placebo: PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Unprimed: DEN-3, >10 ED50 | 4.4 percent of subject with attribute |
| Placebo: PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-1, >10 ED50 | 90.9 percent of subject with attribute |
| Placebo: PII (M7) | Percent of Subjects With Neut. Sero-response to Each DEN Serotype | Primed: DEN-3, >10 ED50 | 92.9 percent of subject with attribute |
Secondary
Vaccine Response to DEN Antibody at Post Dose 1, Month 3
Vaccine response for DEN-1, DEN-2, DEN-3 and DEN-4 antibody S- = seronegative subjects (antibody titer \<10 ED50 for DEN-1, 2, 3, and 4 prior to vaccination; S+ = Seropositive subjects (antibody titer \>10 ED50 for DEN-1, 2, 3 and 4 prior to vaccination; Total = subjects either seropositive or seronegative at pre-vaccination Vaccine response defined as: For initially seronegative subjects, antibody titer \>10 ED50 at PI(M3) and for initially seropositive subjects: antibody titer at PI(m3) \>4 fold the pre-vaccination antibody titer
Time frame: at month 3, post dose 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-DEN-Post-Transfection F17 | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 20.2 % of subjects |
| T-DEN-Post-Transfection F19 | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 54.1 % of subjects |
| Placebo | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 30.6 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 30.2 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 73.7 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 46.5 % of subjects |
| F19 PI (M6) | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 7.8 % of subjects |
| F19 PII (M7) | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 7.0 % of subjects |
| Placebo: Pre-vaccination | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 7.5 % of subjects |
| Placebo: PI (M3) | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 25.9 % of subjects |
| Placebo: PI (M6) | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 63.6 % of subjects |
| Placebo: PII (M7) | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 36.4 % of subjects |
| DEN-2, F19, S- | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 46.0 % of subjects |
| DEN-2, F19, S+ | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 64.4 % of subjects |
| DEN-2, F19, Total | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 53.7 % of subjects |
| DEN-2, Placebo, S- | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 3.9 % of subjects |
| DEN-2, Placebo, S+ | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 14.0 % of subjects |
| DEN-2, Placebo, Total | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 7.6 % of subjects |
| DEN-3, F17, S- | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 15.3 % of subjects |
| DEN-3, F17, S+ | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 61.1 % of subjects |
| DEN-3, F17, Total | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 28.9 % of subjects |
| DEN-3, F19, S- | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 28.8 % of subjects |
| DEN-3, F19, S+ | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 62.2 % of subjects |
| DEN-3, F19, Total | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 42.3 % of subjects |
| DEN-3, Placebo, S- | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 6.2 % of subjects |
| DEN-3, Placebo, S+ | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 5.1 % of subjects |
| DEN-3, Placebo, Total | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 5.8 % of subjects |
| DEN-4, F17, S- | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 38.8 % of subjects |
| DEN-4, F17, S+ | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 52.4 % of subjects |
| DEN-4, F17, Total | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 43.3 % of subjects |
| DEN-4, F19, S- | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 27.9 % of subjects |
| DEN-4, F19, S+ | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 65.3 % of subjects |
| DEN-4, F19, Total | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 44.5 % of subjects |
| DEN-4, Placebo, S- | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 7.6 % of subjects |
| DEN-4, Placebo, S+ | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 11.1 % of subjects |
| DEN-4, Placebo, Total | Vaccine Response to DEN Antibody at Post Dose 1, Month 3 | 8.9 % of subjects |
Secondary
Vaccine Response to DEN Antibody at Post Dose 2, Month 7
Vaccine response for DEN-1, DEN2, DEN-3, DEN-4 antibody at post dose 2, month 7
Time frame: at month 7, post dose 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T-DEN-Post-Transfection F17 | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 95.2 % of subjects |
| T-DEN-Post-Transfection F19 | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 60.0 % of subjects |
| Placebo | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 84.7 % of subjects |
| After 31-Day Post Vaccination Period: F17 | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 83.6 % of subjects |
| After 31-Day Post Vaccination Period: F19 | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 75.7 % of subjects |
| After 31-Day Post-Vaccination Period: Placebo | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 80.6 % of subjects |
| F19 PI (M6) | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 6.8 % of subjects |
| F19 PII (M7) | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 11.6 % of subjects |
| Placebo: Pre-vaccination | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 8.5 % of subjects |
| Placebo: PI (M3) | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 89.3 % of subjects |
| Placebo: PI (M6) | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 71.9 % of subjects |
| Placebo: PII (M7) | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 84.5 % of subjects |
| DEN-2, F19, S- | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 93.5 % of subjects |
| DEN-2, F19, S+ | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 64.3 % of subjects |
| DEN-2, F19, Total | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 81.7 % of subjects |
| DEN-2, Placebo, S- | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 4.1 % of subjects |
| DEN-2, Placebo, S+ | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 14.0 % of subjects |
| DEN-2, Placebo, Total | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 7.8 % of subjects |
| DEN-3, F17, S- | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 92.9 % of subjects |
| DEN-3, F17, S+ | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 47.1 % of subjects |
| DEN-3, F17, Total | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 79.7 % of subjects |
| DEN-3, F19, S- | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 79.7 % of subjects |
| DEN-3, F19, S+ | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 48.8 % of subjects |
| DEN-3, F19, Total | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 67.3 % of subjects |
| DEN-3, Placebo, S- | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 9.0 % of subjects |
| DEN-3, Placebo, S+ | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 15.4 % of subjects |
| DEN-3, Placebo, Total | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 11.1 % of subjects |
| DEN-4, F17, S- | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 97.6 % of subjects |
| DEN-4, F17, S+ | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 57.5 % of subjects |
| DEN-4, F17, Total | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 84.7 % of subjects |
| DEN-4, F19, S- | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 86.7 % of subjects |
| DEN-4, F19, S+ | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 68.8 % of subjects |
| DEN-4, F19, Total | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 78.7 % of subjects |
| DEN-4, Placebo, S- | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 7.9 % of subjects |
| DEN-4, Placebo, S+ | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 6.7 % of subjects |
| DEN-4, Placebo, Total | Vaccine Response to DEN Antibody at Post Dose 2, Month 7 | 7.4 % of subjects |