Dengue
Conditions
Keywords
Dengue, Vaccine, Thailand
Brief summary
One year follow-up on immunogenicity and safety of a booster dose of DEN vaccine administered approx. 1 year following the second dose
Detailed description
The purpose of this study is to find out more about the two doses of dengue vaccine, over a five year period, that the children received in the Dengue-003 study and to study a third dose of dengue that will be given to the children * Do children still have dengue antibodies intended to provide protection against dengue infection one year after the two doses of vaccine given in study Dengue-003? * Were there any major medical problems that appeared as dengue-like symptoms during the one year after vaccinations? * Will a third dose of dengue help to further stimulate the part of the immune system intended to help protect against dengue infection? * Is a third dose as safe as the first two doses? * Are the local reactions to a third dose of the vaccine similar to what your child experienced after the first two doses?
Interventions
BIOLOGICALDEN vaccine F17
The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).
Sponsors
GlaxoSmithKline
U.S. Army Medical Research and Development Command
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who received two doses of DEN vaccine in the Dengue-003 study * Subjects whos parents signed an informed consent form were eligible for participation in the five year follow-up study
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 | Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points. |
| Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 | Neutralizing antibodies as measured by plaque reduction neutralization test (geometric mean titers \[GMTs\]) to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events (SAE) Within 31 Days Post Vaccination | 31 days | Occurrence of SAEs within 31 days (Day 0-30) after vaccination |
| Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination | 31 days | Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort) |
| Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Prebooster year 1, 30 Days Post Booster, Year 2, Year 3 | Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity) |
| Solicited Local Adverse Events (AEs) Within 21 Day Follow-up | 21 days | Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort). |
| Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | 1 year, 30 Days Post Booster, 2 years | The ratio of DEN Immunoglobulin type M and G (IgM:IgG) measured at the time of booster vaccination and 30 days following was used to assess intercurrent flavivirus infection. Flavivirus infection in terms of dengue IgM and IgG and Japanese encephalitis virus (JEV) IgM and IgG is summarized. Flavivirus immunity= ratio IgM on IgG \<1.8 with either IgM or IgM \>1:40 If the antibody response is detectable by isotype capture enzyme immunoassay (either the IgM or IgG component ≥40 U), its anamnestic character can be inferred from detection of a DEN IgM to IgG ratio of \<1.8. |
| Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Year 1 (day 0); Year 1 (day 30); Year 2 | Clinical safety laboratory test were monitored for alert levels. Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717. Normal Ranges: Alanine Aminotransferases (ALT): LNL=0 and UNL=30 Aspartate Aminotransferases (AST): LNL=0 and UNL=40 Platelet (PLA): LNL=150000 and UNL=350000 Hematocrit (HC): LNL=35 and UNL=45 Neutrophil (NEU): LNL=1500 and UNL=8000 |
| Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose | 10 days | Nested Polymerase Chain Reaction (PCR) for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination |
| Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination | 31 days | Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort) |
Countries
Thailand
Participant flow
Recruitment details
Seven Thai children from the Dengue-03 study will be invited to participate
Participants by arm
| Arm | Count |
|---|---|
| Total Vaccinated The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003
DEN vaccine F17: The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4). | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Total Vaccinated |
|---|---|
| Age, Continuous | 8.3 years STANDARD_DEVIATION 0.49 |
| Region of Enrollment Thailand | 7 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
Neutralizing antibodies as measured by plaque reduction neutralization test (geometric mean titers \[GMTs\]) to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.
Time frame: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-1: Pre-booster Year 1 | 6.0 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-1: 30 Days Post-booster | 28.2 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-1: Year 2 | 6.8 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-1: Year 3 | 18.0 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-2: Pre-booster Year 1 | 16.8 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-2: 30 Day Post-booster | 94.4 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-2: Year 2 | 20.8 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-2: Year 3 | 36.3 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-3: Pre-booster Year 1 | 12.8 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-3: 30 Days post-booster | 67.2 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-3: Year 2 | 9.4 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-3: Year 3 | 12.9 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-4: Pre-booster Year 1 | 27.0 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-4: 30 Days Post-booster | 112.0 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-4: Year 2 | 25.4 GMTs |
| > 10 ED50 | Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-4: Year 3 | 70.4 GMTs |
Primary
Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.
Time frame: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3
Population: Immunogenicity data for one subject was not included in the ATP analysis due to an asymptomatic, sub-clinical, wild-type DEN-2 virus infection prior to DEN vaccine dose 1
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-4: Year 3 | 100 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-1: Prebooster Year 1 | 16.7 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-1: 30 Days Post Booster | 83.3 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-1: Year 2 | 16.7 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-1: Year 3 | 66.7 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-2: Prebooster Year 1 | 50.0 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-2: 30 Days Post Booster | 100 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-2: Year 2 | 66.7 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-2: Year 3 | 83.3 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-3: Prebooster Year 1 | 33.3 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-3: 30 Days Post Booster | 100 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-3: Year 2 | 33.3 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-3: Year 3 | 50.0 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-4: Prebooster Year 1 | 50.0 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-4: 30 days Post Booster | 100 % of subjects |
| > 10 ED50 | Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity) | N lg to DEN-4: Year 2 | 50.0 % of subjects |
Secondary
Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination
Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort)
Time frame: 31 days
Population: Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| > 10 ED50 | Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination | 42.9 Percentage of subjects |
Secondary
Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
The ratio of DEN Immunoglobulin type M and G (IgM:IgG) measured at the time of booster vaccination and 30 days following was used to assess intercurrent flavivirus infection. Flavivirus infection in terms of dengue IgM and IgG and Japanese encephalitis virus (JEV) IgM and IgG is summarized. Flavivirus immunity= ratio IgM on IgG \<1.8 with either IgM or IgM \>1:40 If the antibody response is detectable by isotype capture enzyme immunoassay (either the IgM or IgG component ≥40 U), its anamnestic character can be inferred from detection of a DEN IgM to IgG ratio of \<1.8.
Time frame: 1 year, 30 Days Post Booster, 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 7: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 7: Year 1 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 7: 30 Days Post Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 7: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 2: 1 Year Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 2: 30 Days Post Booster Ratio | 0.3 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 2: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 2: Year 1 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 2: 30 Days Post Booster Ratio | 0.4 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 2: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 3: Year 1 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 3: 30 Days Post Booster Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 3: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 3: Year 1 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 3: 30 Days Post Booster Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 3: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 4: Year 1 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 4: 30 Days Post Booster Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 4: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 4: Year 1 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 4: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 5: Year 1 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 5: 30 Days Post Booster Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 5: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 5: Year 1 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 5: 30 Days Post Booster Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 5: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 6: Year 1 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 6: 30 Days Post Booster Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 6: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 6: Year 1 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 6: 30 Days Post Booster Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | JEV Subject 6: Year 2 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 7: Year 1 Ratio | 0 Flavivirus immunity ratio |
| > 10 ED50 | Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity) | DEN Subject 7: 30 Days Post Booster Ratio | 0 Flavivirus immunity ratio |
Secondary
Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity)
Time frame: Prebooster year 1, 30 Days Post Booster, Year 2, Year 3
Population: Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity). Immunogenicity data for one subject was not included in the ATP analysis due to an asymptomatic, sub-clinical, wild-type DEN-2 virus infection prior to DEN vaccine dose 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | 30 Days Post Booster: Monovalent | 0.00 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Pre-Booster Year 1: Monovalent | 16.67 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Pre-Booster Year 1: Bivalent | 33.33 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Pre-Booster Year 1: Trivalent | 0.00 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Pre-Booster Year 1: Tetravalent | 16.67 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | 30 Days Post Booster: Bivalent | 0.00 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | 30 Days post Booster: Trivalent | 16.67 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | 30 Days Post Booster: Tetravalent | 83.33 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Year 2: Monovalent | 33.33 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Year 2: Bivalent | 33.33 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Year 2: Trivalent | 0.00 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Year 2: Tetravalent | 16.67 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Year 3: Monovalent | 0.00 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Year 3: Bivalent | 33.33 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Year 3: Trivalent | 33.33 percentage of subjects |
| > 10 ED50 | Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster | Year 3: Tetravalent | 33.33 percentage of subjects |
Secondary
Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose
Nested Polymerase Chain Reaction (PCR) for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination
Time frame: 10 days
Population: Nested PCR for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| > 10 ED50 | Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose | 1 Participants |
Secondary
Serious Adverse Events (SAE) Within 31 Days Post Vaccination
Occurrence of SAEs within 31 days (Day 0-30) after vaccination
Time frame: 31 days
Population: Occurrence of SAEs within 31 days (Day 0-30) after vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| > 10 ED50 | Serious Adverse Events (SAE) Within 31 Days Post Vaccination | 0 Participants |
Secondary
Solicited Local Adverse Events (AEs) Within 21 Day Follow-up
Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort).
Time frame: 21 days
Population: Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| > 10 ED50 | Solicited Local Adverse Events (AEs) Within 21 Day Follow-up | Pain: Grade 3 | 0 Adverse events |
| > 10 ED50 | Solicited Local Adverse Events (AEs) Within 21 Day Follow-up | Pain: All | 3 Adverse events |
| > 10 ED50 | Solicited Local Adverse Events (AEs) Within 21 Day Follow-up | Redness: All | 3 Adverse events |
| > 10 ED50 | Solicited Local Adverse Events (AEs) Within 21 Day Follow-up | Redness: Grade 3 | 0 Adverse events |
| > 10 ED50 | Solicited Local Adverse Events (AEs) Within 21 Day Follow-up | Swelling: All | 4 Adverse events |
| > 10 ED50 | Solicited Local Adverse Events (AEs) Within 21 Day Follow-up | Swelling: Grade 3 | 1 Adverse events |
Secondary
Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
Clinical safety laboratory test were monitored for alert levels. Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717. Normal Ranges: Alanine Aminotransferases (ALT): LNL=0 and UNL=30 Aspartate Aminotransferases (AST): LNL=0 and UNL=40 Platelet (PLA): LNL=150000 and UNL=350000 Hematocrit (HC): LNL=35 and UNL=45 Neutrophil (NEU): LNL=1500 and UNL=8000
Time frame: Year 1 (day 0); Year 1 (day 30); Year 2
Population: Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717. Tests included ALT, AST, PLA, HC, and NEU levels.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 2 | 46 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 10 | 28 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 0 | 11 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 0 | 49 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 10 | 12 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 10 | 12 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 2 | 16 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 30 | 13 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 2 | 12 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7, Year 2 | 13 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 0 | 15 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 0 | 10 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 10 | 15 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 0 | 11 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 10 | 13 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 2 | 16 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 30 | 12 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 1, Day 30 | 12 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 2 | 11 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 1, Day 10 | 13 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 0 | 51 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 30 | 10 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6: Year 1, Day 0 | 10 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 10 | 68 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 30 | 12 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 2 | 26 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 30 | 68 U/L |
| > 10 ED50 | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 30 | 41 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 10 | 36 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7, Year 2 | 27 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 1, Day 30 | 28 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 0 | 45 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 2 | 29 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 0 | 24 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 10 | 26 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 30 | 31 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 2 | 34 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 0 | 28 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 10 | 23 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 30 | 36 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 1, Day 10 | 28 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 30 | 34 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 10 | 44 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 2 | 28 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 2 | 23 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 30 | 29 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 30 | 32 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 0 | 27 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6: Year 1, Day 0 | 27 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 0 | 29 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 2 | 33 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 0 | 28 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 2 | 35 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 30 | 49 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 10 | 30 U/L |
| AST Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 10 | 34 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 0 | 244000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 0 | 494000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 10 | 369000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 30 | 411000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 2 | 502000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 0 | 293000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 10 | 248000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 30 | 296000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 2 | 323000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 0 | 270000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 10 | 272000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 30 | 303000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 2 | 306000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 0 | 280000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 10 | 253000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 30 | 297000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 2 | 231000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 0 | 403000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 10 | 415000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 30 | 329000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 2 | 346000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6: Year 1, Day 0 | 440000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 1, Day 10 | 434000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 1, Day 30 | 417000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 2 | 461000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 10 | 238000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 30 | 270000 U/L |
| PLA Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7, Year 2 | 311000 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 2 | 36.6 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 1, Day 30 | 35.4 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 10 | 40.2 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 10 | 36.9 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 0 | 39.3 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 0 | 37 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 2 | 39.7 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 10 | 37.1 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 0 | 36.1 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 30 | 38.4 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 2 | 38.9 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 0 | 38.6 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6: Year 1, Day 0 | 36.6 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 30 | 38.8 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 30 | 39.3 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 2 | 38.4 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 2 | 40.4 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 30 | 41.8 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 10 | 41.8 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 10 | 39.9 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 1, Day 10 | 38 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 10 | 37.1 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 2 | 43.1 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 30 | 42.3 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 0 | 38.8 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 30 | 35.9 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7, Year 2 | 41.4 U/L |
| HC Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 0 | 39 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 0 | 3320 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 30 | 4380 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 10 | 3020 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 10 | 4580 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 10 | 3750 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 30 | 2970 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 1, Day 0 | 2580 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 2 | 5920 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 2 | 2400 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6: Year 1, Day 0 | 3020 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 30 | 3070 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 30 | 2940 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 1, Day 10 | 3390 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 10 | 2770 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 0 | 2820 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 1, Day 30 | 2690 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 2: Year 1, Day 0 | 3210 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 6, Year 2 | 3840 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 2 | 4790 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 0 | 3460 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 1: Year 1, Day 30 | 3000 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 10 | 3460 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7, Year 2 | 4240 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 1, Day 30 | 3320 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 5: Year 1, Day 0 | 3950 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 4: Year 2 | 3900 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 3: Year 2 | 5170 U/L |
| NEU Level | Subject Biochemistry and Hematology Parameters Monitored for Alert Levels | Subject 7: Year 1, Day 10 | 3050 U/L |
Secondary
Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination
Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort)
Time frame: 31 days
Population: Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| > 10 ED50 | Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination | At Least One Symptom | 85.7 Percentage of subjects |
| > 10 ED50 | Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination | Infections and Infestations | 14.3 Percentage of subjects |
| > 10 ED50 | Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination | Injury, Poisoning and Procedural Complications | 14.3 Percentage of subjects |
| > 10 ED50 | Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination | Nervous System Disorders | 42.9 Percentage of subjects |
| > 10 ED50 | Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination | Renal and Urinary Disorders | 14.3 Percentage of subjects |
| > 10 ED50 | Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination | Respiratory, Thoracic and Mediastinal Disorders | 28.6 Percentage of subjects |