Dengue
Conditions
Keywords
Dengue Virus
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults, adolescents, and children in Dhaka, Bangladesh.
Detailed description
Dengue viruses (DENV) are the leading arboviral infection globally, with over 2 billion people at risk of infection worldwide. The first dengue fever outbreak in Bangladesh occurred in 2000, and since then, dengue fever has had a continued presence throughout Bangladesh. This study will evaluate the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults, adolescents, and children in Dhaka, Bangladesh. The study will enroll four cohorts of participants: adults, adolescents, children, and young children. Study researchers will evaluate study data for each cohort before enrolling the subsequent cohort. Participants will be randomly assigned to receive either TV005 vaccine or placebo at study entry (Day 0). Additional study visits will occur on Days 7, 14, 28, 56, 180, 360, 720, and 1080. Study visits will include blood collection, physical examinations, and clinical assessments. Participants will record and monitor their temperature and symptoms until Day 14. Study staff will contact participants daily until Day 14; after Day 14, study staff will contact participants weekly (and after Day 180, monthly) throughout the study for follow-up health monitoring.
Interventions
BIOLOGICALTV005 vaccine
Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.
BIOLOGICALPlacebo
Delivered by subcutaneous injection
Sponsors
University of Vermont
Johns Hopkins Bloomberg School of Public Health
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or females (non-pregnant or lactating) between the ages of 12 months and 50 years at the time of enrollment into the study. * Reside in Mirpur Wards 2, 3, or 5 (or other Wards within Mirpur as designated by the PI if needed to reach enrollment targets) at the time of screening. * Study participants and/or their parents/guardians/legally acceptable or authorized representatives (LARs) who the Investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits). * Good general health as determined by physical examination, laboratory screening, and review of medical history. * If the participant is greater than or equal to 18 years of age, an informed consent form signed and dated by the study participant (and by an independent witness if required by local regulations). If the study participant is a minor, an assent form (for participants age 11-17 years) and informed consent form signed and dated by the participant's properly identified parent(s) or legally acceptable representative. If a participant is less than 11 years of age, the participant's parent(s) or legally acceptable representative will consent by signing the consent form for minor participants. * If the participant is female, she must not be pregnant or planning to become pregnant up to 28 days post vaccination. Female participants under the age of 18 will be enrolled, if they have not yet reached menarche. Females 18 years of age or older, must be properly using a method of pregnancy prevention that is known to be highly effective per the PI. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, and abstinence (greater than or equal to 6 months since last sexual encounter). For female study participants who are 18 years of age or older pregnancy testing will occur at screening and again before vaccination and they must have a negative pregnancy test prior to vaccination. Additionally, they will receive counselling on the importance of effective contraception during the 30 days prior to vaccination and continuing up to Day 28. Counselling will occur at their screening visit, on all clinic visit days up to Day 28. Female participants 18 years of age and older will be subject to pregnancy testing on the Study Day 28 and 56 visits. If female participants under the age of 18 that have not yet reached menarche prior to enrollment, reach menarche during the study, they will continue to be enrolled and followed-up through the entire three year follow-up period.
Exclusion criteria
* Pregnant or lactating female or female planning to become pregnant within 28 days of receiving an investigational product or planning to discontinue abstinence or contraceptive precautions within 28 days of receiving an investigational product. Menstruating females under the age of 18 will be excluded from being enrolled. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal, autoimmune, hematologic, or endocrine disease or functional defect, as determined by history, physical examination, or screening tests. * History of any neurological, psychiatric, or behavioural disorder or seizures, with the exception of a single febrile seizure in childhood. * Self-reported or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent, greater than or equal to 0.5 mg/kg/day or 20 mg/day, for more than 2 consecutive weeks within the past 3 months). Inhaled and topical steroids are allowed. * Having a height-for-age z-score (HAZ) or weight-for-age z-score (WAZ) of less than or equal to 3 for children under the age of two. Severe malnutrition as observed by the study physician for all study participants ages 2 years old and older. * Hepatitis C virus (HCV) infection by screening and confirmatory assays (screening in adults and adolescents only), or hepatitis B virus (HBV) infection, by hepatitis B surface antigen (HBsAg) screening (all participants) or, unwilling to allow HCV (adults and adolescents only) and HBV testing. * Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine transaminase (ALT), or platelet count, as defined in this protocol. * For children under 5 years of age, screening laboratory values of Grade 1 or above for Haemoglobin. * History of allergic reaction likely to be exacerbated by any component of the vaccine; any history of a severe allergic reaction or anaphylaxis. * Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures. * Any other condition that in the opinion of the Investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant unable to comply with the protocol. * Planned administration of any vaccine from 30 days prior to receipt of the study vaccine and ending 30 days after; with the exceptions of standard infant and child Expanded Program on Immunization (EPI) inactivated vaccines and the inactivated influenza vaccine or the inactivated rabies vaccine (without administration of immunoglobulin) administered to adults or children. * Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding receipt of study vaccine/placebo or planned use at any time during the study period or history of having received any investigational dengue vaccine at any previous time. * Current participation in any clinical or investigational study. * Administration of immunoglobulins and/or blood products within 90 days preceding the dose or planned administration at any time during the study period, which might interfere with assessment of the immune response. * A planned or anticipated move to a location that will prohibit full participation in the trial for the three year duration. * Potential adult volunteers or parents of potential child volunteers, who do not have easy access to a fixed or mobile telephone. * Any participant that resides in a household with an individual previously enrolled in an older age cohort in this study. Only one participant from each household will be enrolled. * Any participant identified as a site employee of the Investigator or study clinic, with direct involvement in the proposed study or other studies under the direction of that Investigator or study clinic, as well as any immediate family member (such as husband, wife and their children, adopted or natural) of the clinic employees or the Investigator. Elimination Criteria During the Study: The following criteria should be checked at each visit subsequent to the first visit. If any become applicable during the study, it will not require withdrawal of the participant from the study but may determine a participant's evaluability in the per-protocol (PP) analysis. The participant will continue to be evaluated for safety purposes at the regularly scheduled visits. See the protocol for definition of study cohorts to be evaluated. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/placebo during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed. * Administration of a licensed vaccine during the period starting from 30 days before dose of vaccine/placebo and ending 30 days after, with the exception of standard infant and childhood EPI inactivated vaccinations. * Administration of immunoglobulins and/or any blood products during the study period. * Pregnancy within the 28 days after investigational product administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Vaccine/placebo administration (study day 0) up to 28 days post vaccine/placebo administration | Collected through daily home visits up to day 14, clinic visits for physical exam and hematological and blood chemistry labs, and weekly phone surveillance after day 14. Study staff record temperatures and AEs on the surveillance source document. |
| Percentage of Study Participants Who Are Seropositive Following Vaccination | Study day 14 through study day 180 | Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 58, and 180 post vaccination. Seropositivity to each serotype as defined as PRNT50\>=10. Per protocol analysis includes participants meeting eligibility criteria, complying with defined visits and protocols, no elimination criteria, and immunogenicity data endpoints measures available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination | Vaccine administration (study day 0) up to 14 days post vaccine administration | Viremia in serum was determined both by amplification and direct titration using Vero cell monolayers. Each specific serotype was identified using monoclonal antibodies. |
| Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees. | Study day 14 through study day 180 | Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 56, and 180 post vaccination. Seropositivity to each serotype is defined as PRNT50 ≥ 10. |
| Durability of Seropositivity Post TV005 Vaccination | Vaccine/placebo administration (study day 0) up to three years post vaccine/placebo administration (study day 1080). | Estimated percent seropositive, over 3 years by age group and serotype. Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 56, 180, 360, 720, and 1080 post vaccination. Seropositivity to each serotype is defined as PRNT50 ≥ 10. |
Countries
Bangladesh
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TV005 Vaccine Participants will receive one dose of TV005 vaccine at study entry (Day 0).
TV005 vaccine: Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30. | 144 |
| Placebo Participants will receive one dose of placebo at study entry (Day 0).
Placebo: Delivered by subcutaneous injection | 48 |
| Total | 192 |
Baseline characteristics
| Characteristic | TV005 Vaccine | Placebo | Total |
|---|---|---|---|
| Age Cohort Adolescent group (11-17 years) | 36 Participants | 12 Participants | 48 Participants |
| Age Cohort Adult group (18-50 years) | 36 Participants | 12 Participants | 48 Participants |
| Age Cohort Children group (5-10 years) | 36 Participants | 12 Participants | 48 Participants |
| Age Cohort Young children group (1-4 years) | 36 Participants | 12 Participants | 48 Participants |
| Age, Customized Adolescent | 12.58 Years STANDARD_DEVIATION 1.81 | 12.83 Years STANDARD_DEVIATION 1.64 | 12.65 Years STANDARD_DEVIATION 1.75 |
| Age, Customized Adult | 32.17 Years STANDARD_DEVIATION 8.26 | 29.25 Years STANDARD_DEVIATION 5.1 | 31.44 Years STANDARD_DEVIATION 8.24 |
| Age, Customized Children | 8.14 Years STANDARD_DEVIATION 1.46 | 7.83 Years STANDARD_DEVIATION 1.34 | 8.06 Years STANDARD_DEVIATION 1.42 |
| Age, Customized Young Children | 3.25 Years STANDARD_DEVIATION 0.81 | 3.42 Years STANDARD_DEVIATION 0.52 | 3.29 Years STANDARD_DEVIATION 0.74 |
| Dengue Serostatus Dengue Experienced | 63 Participants | 26 Participants | 89 Participants |
| Dengue Serostatus Dengue Naive | 81 Participants | 22 Participants | 103 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 144 Participants | 48 Participants | 192 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Bangladesh | 144 participants | 48 participants | 192 participants |
| Sex/Gender, Customized Adolescent Female | 17 Participants | 4 Participants | 21 Participants |
| Sex/Gender, Customized Adolescent Male | 19 Participants | 8 Participants | 27 Participants |
| Sex/Gender, Customized Adult Female | 23 Participants | 5 Participants | 28 Participants |
| Sex/Gender, Customized Adult Male | 13 Participants | 7 Participants | 20 Participants |
| Sex/Gender, Customized Child Female | 26 Participants | 7 Participants | 33 Participants |
| Sex/Gender, Customized Child Male | 10 Participants | 5 Participants | 15 Participants |
| Sex/Gender, Customized Young Child Female | 14 Participants | 5 Participants | 19 Participants |
| Sex/Gender, Customized Young Child Male | 22 Participants | 7 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 144 | 0 / 48 |
| other Total, other adverse events | 95 / 144 | 25 / 48 |
| serious Total, serious adverse events | 6 / 144 | 0 / 48 |
Outcome results
Primary
Percentage of Study Participants Who Are Seropositive Following Vaccination
Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 58, and 180 post vaccination. Seropositivity to each serotype as defined as PRNT50\>=10. Per protocol analysis includes participants meeting eligibility criteria, complying with defined visits and protocols, no elimination criteria, and immunogenicity data endpoints measures available.
Time frame: Study day 14 through study day 180
Population: Only TV005 Vaccine arm included in analysis as per protocol to determine percentage of participants in TV005 vaccine arm who are seropositive after vaccination. Data is analyzed for each sub-group. Two participants (one each in Adult and Adolescent vaccine group) were eliminated from this analysis. There are 35 participants in Adult and Adolescent vaccine Arm groups; 36 in Children, and Young Children vaccine Arm groups with a total of 142 included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | All study participants seropositive to DENV-1 post TV005 Vaccination | 83 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | All study participants seropositive to DENV-2 post TV005 Vaccination | 99 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | All study participants seropositive to DENV-3 post TV005 Vaccination | 96 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | All study participants seropositive to DENV-4 post TV005 Vaccination | 87 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Adult study participants seropositive to DENV-1 post TV005 vaccination | 86 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Adult study participants seropositive to DENV-2 post TV005 vaccination | 97 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Adult study participants seropositive to DENV-3 post TV005 vaccination | 97 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Adult study participants seropositive to DENV-4 post TV005 vaccination | 91 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Adolescent study participants seropositive to DENV-1 post TV005 vaccination | 83 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Adolescent study participants seropositive to DENV-2 post TV005 vaccination | 100 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Adolescent study participants seropositive to DENV-3 post TV005 vaccination | 97 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Adolescent study participants seropositive to DENV-4 post TV005 vaccination | 86 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Children study participants seropositive to DENV-1 post TV005 vaccination | 81 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Children study participants seropositive to DENV-2 post TV005 vaccination | 100 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Children study participants seropositive to DENV-3 post TV005 vaccination | 100 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Children study participants seropositive to DENV-4 post TV005 vaccination | 78 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Young children study participants seropositive to DENV-1 post TV005 vaccination | 83 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Young children study participants seropositive to DENV-2 post TV005 vaccination | 100 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Young children study participants seropositive to DENV-3 post TV005 vaccination | 92 Percentage of participants |
| TV005 Vaccine | Percentage of Study Participants Who Are Seropositive Following Vaccination | Young children study participants seropositive to DENV-4 post TV005 vaccination | 94 Percentage of participants |
Comparison: All study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [76, 88]
Comparison: All study participants seropositive to DENV-2 post TV005 Vaccination. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [96, 100]
Comparison: All study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [92, 98]
Comparison: All study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [81, 92]
Comparison: Adult study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [71, 94]
Comparison: Adult study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [85, 99]
Comparison: Adult study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [85, 99]
Comparison: Adult study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [78, 97]
Comparison: Adolescent study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [67, 92]
Comparison: Adolescent study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [90, 100]
Comparison: Adolescent study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [85, 99]
Comparison: Adolescent study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [71, 94]
Comparison: Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [65, 90]
Comparison: Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [90, 100]
Comparison: Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [90, 100]
Comparison: Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [62, 88]
Comparison: Young Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [68, 92]
Comparison: Young Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [90, 100]
Comparison: Young Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [78, 97]
Comparison: Young Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [82, 98]
Primary
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Collected through daily home visits up to day 14, clinic visits for physical exam and hematological and blood chemistry labs, and weekly phone surveillance after day 14. Study staff record temperatures and AEs on the surveillance source document.
Time frame: Vaccine/placebo administration (study day 0) up to 28 days post vaccine/placebo administration
Population: Per Protocol: all participants who received study vaccine/placebo according to random assignment according to dose are in analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | PTT Prolonged | 4 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Arthralgia | 7 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Hemoglobin Decreased | 5 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Fatigue | 7 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Thrombocytopenia | 4 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Myalgia | 7 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | ALT Increased | 5 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Nausea | 6 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Fever | 7 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Photophobia | 1 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Leukocytosis | 2 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Retro-orbital Pain | 3 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Headache | 17 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Decrease in Activity | 1 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Swelling | 1 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Loss of Appetite | 1 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Rash | 37 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Vomiting | 3 Participants |
| TV005 Vaccine | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Erythema | 1 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Vomiting | 0 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Erythema | 0 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Swelling | 0 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | ALT Increased | 2 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Hemoglobin Decreased | 2 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Leukocytosis | 1 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | PTT Prolonged | 2 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Thrombocytopenia | 0 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Fever | 0 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Headache | 7 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Rash | 6 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Arthralgia | 0 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Fatigue | 2 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Myalgia | 1 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Nausea | 2 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Photophobia | 0 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Retro-orbital Pain | 1 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Decrease in Activity | 0 Participants |
| Placebo | Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity. | Loss of Appetite | 0 Participants |
Comparison: Erythema95% CI: [-0.216, 0.141]
Comparison: Swelling95% CI: [-0.216, 0.141]
Comparison: ALT Increased95% CI: [-0.135, 0.119]
Comparison: Hemoglobin Decreased95% CI: [-0.135, 0.119]
Comparison: Leukocytosis95% CI: [-0.205, 0.121]
Comparison: PTT Prolonged95% CI: [-0.127, 0.111]
Comparison: Thrombocytopenia95% CI: [0.022, 0.134]
Comparison: Fever95% CI: [0.018, 0.118]
Comparison: Headache95% CI: [-0.203, 0.089]
Comparison: Rash95% CI: [0.016, 0.275]
Comparison: Arthralgia95% CI: [0.03, 0.126]
Comparison: Fatigue95% CI: [-0.155, 0.118]
Comparison: Myalgia95% CI: [-0.105, 0.105]
Comparison: Nausea95% CI: [-0.16, 0.114]
Comparison: Photophobia95% CI: [-0.216, 0.141]
Comparison: Retro-orbital Pain95% CI: [-0.142, 0.088]
Comparison: Decrease in Activity95% CI: [-0.216, 0.141]
Comparison: Loss of Appetite95% CI: [-0.216, 0.141]
Comparison: Vomiting95% CI: [-0.165, 0.218]
Secondary
Durability of Seropositivity Post TV005 Vaccination
Estimated percent seropositive, over 3 years by age group and serotype. Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 56, 180, 360, 720, and 1080 post vaccination. Seropositivity to each serotype is defined as PRNT50 ≥ 10.
Time frame: Vaccine/placebo administration (study day 0) up to three years post vaccine/placebo administration (study day 1080).
Population: Only TV005 Vaccine arm included in analysis as per protocol to determine percentage of participants in TV005 vaccine arm who are seropositive after vaccination. Data is analyzed for each sub-group. Two participants (one each in Adult and Adolescent vaccine group) were eliminated from this analysis. There are 35 participants in Adult and Adolescent vaccine Arm groups; 36 in Children, and Young Children vaccine Arm groups with a total of 142 included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-1 at study day 0 | 66 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-1 at study day 28 | 83 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-1 at study day 56 | 80 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-1 at study day 180 | 80 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-1 at study day 360 | 80 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-1 at study day 720 | 66 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-1 at study day 1080 | 66 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-2 at study day 0 | 69 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-2 at study day 28 | 94 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-2 at study day 56 | 97 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-2 at study day 180 | 89 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-2 at study day 360 | 89 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-2 at study day 720 | 91 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-2 at study day 1080 | 86 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-3 at study day 0 | 71 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-3 at study day 28 | 94 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-3 at study day 56 | 91 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-3 at study day 180 | 89 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-3 at study day 360 | 86 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-3 at study day 720 | 89 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-3 at study day 1080 | 80 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-4 at study day 0 | 20 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-4 at study day 28 | 77 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-4 at study day 56 | 80 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-4 at study day 180 | 74 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-4 at study day 360 | 66 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-4 at study day 720 | 60 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adult cohort: percent seropositive to DENV-4 at study day 1080 | 63 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-1 at study day 0 | 26 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-1 at study day 28 | 74 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-1 at study day 56 | 71 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-1 at study day 180 | 71 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-1 at study day 360 | 69 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-1 at study day 720 | 43 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-1 at study day 1080 | 46 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-2 at study day 0 | 34 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-2 at study day 28 | 100 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-2 at study day 56 | 97 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-2 at study day 180 | 97 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-2 at study day 360 | 85 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-2 at study day 720 | 74 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-2 at study day 1080 | 69 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-3 at study day 0 | 37 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-3 at study day 28 | 89 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-3 at study day 56 | 94 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-3 at study day 180 | 97 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-3 at study day 360 | 89 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-3 at study day 720 | 57 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-3 at study day 1080 | 57 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-4 at study day 0 | 0 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-4 at study day 28 | 83 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-4 at study day 56 | 77 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-4 at study day 180 | 71 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-4 at study day 360 | 66 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-4 at study day 720 | 60 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Adolescent cohort: percent seropositive to DENV-4 at study day 1080 | 43 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-1 at study day 0 | 31 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-1 at study day 28 | 69 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-1 at study day 56 | 61 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-1 at study day 180 | 56 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-1 at study day 360 | 42 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-1 at study day 720 | 42 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-1 at study day 1080 | 36 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-2 at study day 0 | 33 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-2 at study day 28 | 92 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-2 at study day 56 | 89 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-2 at study day 180 | 92 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-2 at study day 360 | 78 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-2 at study day 720 | 67 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-2 at study day 1080 | 58 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-3 at study day 0 | 36 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-3 at study day 28 | 92 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-3 at study day 56 | 92 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-3 at study day 180 | 97 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-3 at study day 360 | 72 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-3 at study day 720 | 72 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-3 at study day 1080 | 67 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-4 at study day 0 | 11 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-4 at study day 28 | 72 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-4 at study day 56 | 56 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-4 at study day 180 | 44 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-4 at study day 360 | 28 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-4 at study day 720 | 25 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Children cohort: percent seropositive to DENV-4 at study day 1080 | 19 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-1 at study day 0 | 11 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-1 at study day 28 | 78 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-1 at study day 56 | 42 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-1 at study day 180 | 53 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-1 at study day 360 | 28 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-1 at study day 720 | 28 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-1 at study day 1080 | 28 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-2 at study day 0 | 11 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-2 at study day 28 | 97 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-2 at study day 56 | 86 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-2 at study day 180 | 81 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-2 at study day 360 | 83 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-2 at study day 720 | 72 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-2 at study day 1080 | 69 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-3 at study day 0 | 8 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-3 at study day 28 | 86 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-3 at study day 56 | 67 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-3 at study day 180 | 50 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-3 at study day 360 | 25 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-3 at study day 720 | 31 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-3 at study day 1080 | 25 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-4 at study day 0 | 3 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-4 at study day 28 | 89 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-4 at study day 56 | 72 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-4 at study day 180 | 47 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-4 at study day 360 | 28 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-4 at study day 720 | 28 percentage of participants |
| TV005 Vaccine | Durability of Seropositivity Post TV005 Vaccination | Young Children cohort: percent seropositive to DENV-4 at study day 1080 | 22 percentage of participants |
Comparison: Adult cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [78, 97]
Comparison: Adult cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [49, 79]
Comparison: Adult cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [67, 92]
Comparison: Adult cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [64, 90]
Comparison: Adult cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [64, 90]
Comparison: Adult cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [64, 90]
Comparison: Adult cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [49, 79]
Comparison: Adult cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [49, 79]
Comparison: Adult cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [52, 81]
Comparison: Adult cohort: percent seropositive to DENV-2 at stud day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [81, 98]
Comparison: Adult cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [85, 99]
Comparison: Adult cohort: percent seropositive to DENV-2 at study day 180. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [74, 95]
Comparison: Adult cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [74, 95]
Comparison: Adult cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [78, 97]
Comparison: Adult cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [71, 94]
Comparison: Adult cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [55, 84]
Comparison: Adult cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [81, 98]
Comparison: Adult cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [74, 95]
Comparison: Adult cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [71, 94]
Comparison: Adult cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [74, 95]
Comparison: Adult cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [64, 90]
Comparison: Adult cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [10, 36]
Comparison: Adult cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [61, 88]
Comparison: Adult cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [64, 90]
Comparison: Adult cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [58, 86]
Comparison: Adult cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [49, 79]
Comparison: Adult cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [44, 74]
Comparison: Adult cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [46, 77]
Comparison: Adolescent cohort: percent seropositive to DENV-1 a study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [14, 42]
Comparison: Adolescent cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [58, 86]
Comparison: Adolescent cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [55, 84]
Comparison: Adolescent cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [55, 84]
Comparison: Adolescent cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [52, 81]
Comparison: Adolescent cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [28, 59]
Comparison: Adolescent cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [30, 62]
Comparison: Adolescent cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [21, 51]
Comparison: Adolescent cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [90, 100]
Comparison: Adolescent cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [85, 99]
Comparison: Adolescent cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [85, 99]
Comparison: Adolescent cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [71, 94]
Comparison: Adolescent cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [58, 86]
Comparison: Adolescent cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [52, 81]
Comparison: Adolescent cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [23, 54]
Comparison: Adolescent cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [74, 95]
Comparison: Adolescent cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [81, 98]
Comparison: Adolescent cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [85, 99]
Comparison: Adolescent cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [74, 95]
Comparison: Adolescent cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [41, 72]
Comparison: Adolescent cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [41, 72]
Comparison: Adolescent cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [0, 10]
Comparison: Adolescent cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [67, 92]
Comparison: Adolescent cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [61, 88]
Comparison: Adolescent cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [55, 84]
Comparison: Adolescent cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [49, 79]
Comparison: Adolescent cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [44, 74]
Comparison: Adolescent cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [28, 59]
Comparison: Children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [18, 47]
Comparison: Children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [53, 82]
Comparison: Children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [45, 75]
Comparison: Children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [40, 70]
Comparison: Children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [27, 58]
Comparison: Children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [27, 58]
Comparison: Children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [22, 54]
Comparison: Children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [20, 50]
Comparison: Children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [78, 97]
Comparison: Children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [75, 96]
Comparison: Children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [78, 97]
Comparison: children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [62, 88]
Comparison: Children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [50, 80]
Comparison: Children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [42, 73]
Comparison: Children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [22, 52]
Comparison: Children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [78, 97]
Comparison: Children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [78, 97]
Comparison: Children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [86, 100]
Comparison: Children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [56, 84]
Comparison: Children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [56, 84]
Comparison: Children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [50, 80]
Comparison: Children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [4, 25]
Comparison: Children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [56, 84]
Comparison: Children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [40, 70]
Comparison: children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [30, 60]
Comparison: Children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [16, 44]
Comparison: Children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [14, 41]
Comparison: children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [10, 35]
Comparison: Young children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [4, 25]
Comparison: Young children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [62, 88]
Comparison: young children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [27, 58]
Comparison: young children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [37, 68]
Comparison: Young children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [16, 44]
Comparison: young children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [16, 44]
Comparison: Young children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [16, 44]
Comparison: Young children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [4, 25]
Comparison: Young children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [86, 100]
Comparison: young children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [71, 94]
Comparison: Young children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [65, 90]
Comparison: young children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [68, 92]
Comparison: young children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [56, 84]
Comparison: Young children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [53, 82]
Comparison: Young children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [3, 22]
Comparison: Young children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [71, 94]
Comparison: young children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [50, 80]
Comparison: young children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [34, 66]
Comparison: young children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [14, 41]
Comparison: young children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [18, 47]
Comparison: young children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [14, 41]
Comparison: young children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [0, 14]
Comparison: young children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [75, 96]
Comparison: young children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [56, 96]
Comparison: young children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [32, 63]
Comparison: young children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [16, 44]
Comparison: young children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [16, 44]
Comparison: young children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.95% CI: [12, 38]
Secondary
Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees.
Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 56, and 180 post vaccination. Seropositivity to each serotype is defined as PRNT50 ≥ 10.
Time frame: Study day 14 through study day 180
Population: Only TV005 Vaccine arm included in analysis as per protocol to determine percentage of participants in TV005 vaccine arm who are seropositive after vaccination. Data is analyzed by sub-groups based on previous exposure to Dengue at baseline (experienced, and naïve). Two participants from the experienced at baseline group were eliminated from this analysis. There are 61 participants in the experienced at baseline group; 81 in the naïve at baseline group; total of 142 included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TV005 Vaccine | Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees. | Experienced at baseline serpositive to DENV-1 post TV005 vaccination | 100 Percentage of participants |
| TV005 Vaccine | Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees. | Experienced at baseline seropositive to DENV-2 post TV005 vaccination | 100 Percentage of participants |
| TV005 Vaccine | Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees. | Experienced at baseline seropositive to DENV-3 post TV005 vaccination | 100 Percentage of participants |
| TV005 Vaccine | Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees. | Experienced at baseline seropoisitive to DENV-4 post TV005 vaccination | 87 Percentage of participants |
| TV005 Vaccine | Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees. | Naive at baseline seropositive to DENV-1 post TV005 vaccination | 70 Percentage of participants |
| TV005 Vaccine | Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees. | Naive at baseline seropositive to DENV-2 post TV005 vaccination | 99 Percentage of participants |
| TV005 Vaccine | Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees. | Naive at baseline seropositive to DENV-3 post TV005 vaccination | 94 Percentage of participants |
| TV005 Vaccine | Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees. | Naive at baseline seropositive to DENV-4 post TV005 vaccination | 88 Percentage of participants |
Comparison: DENV-1 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baselinep-value: <0.001Fisher Exact
Comparison: DENV-2 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baselinep-value: 1Fisher Exact
Comparison: DENV-3 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baselinep-value: 0.07Fisher Exact
Comparison: DENV-4 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baselinep-value: 1Fisher Exact
Secondary
Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination
Viremia in serum was determined both by amplification and direct titration using Vero cell monolayers. Each specific serotype was identified using monoclonal antibodies.
Time frame: Vaccine administration (study day 0) up to 14 days post vaccine administration
Population: Per protocol analysis includes all study participants meeting all eligibility criteria and with viremia data endpoints measures available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TV005 Vaccine | Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination | DENV-2 recovered | 1 Participants |
| TV005 Vaccine | Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination | DENV-4 recovered | 0 Participants |
| TV005 Vaccine | Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination | DENV-3 recovered | 1 Participants |
| TV005 Vaccine | Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination | Total Viremia recovered | 6 Participants |
| TV005 Vaccine | Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination | DENV-1 recovered | 4 Participants |
| Placebo | Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination | Total Viremia recovered | 0 Participants |
| Placebo | Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination | DENV-1 recovered | 0 Participants |
| Placebo | Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination | DENV-2 recovered | 0 Participants |
| Placebo | Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination | DENV-3 recovered | 0 Participants |
| Placebo | Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination | DENV-4 recovered | 0 Participants |