| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | GMTs of neutralizing antibodies were measured by microneutralization test 50% (MNT50) for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 1 at Month 0 for participants from both parent trials (DEN-304 and DEN-315). | Per Protocol Set (PPS) included all participants from the Full Analysis Set (FAS) who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0 (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
| | | Title | Denominators | Categories |
|---|
| DENV-1 | | | Title | Measurements |
|---|
| - OG00076.8(62.0 to 95.2)
- OG00188.6(70.4 to 111.5)
|
| | DENV-2 | | |
| |
| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 2 at Month 12 for participants from both parent trials (DEN-304 and DEN-315). | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
| |
| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 3 at Month 15 for participants from parent trial DEN-304. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 15 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). |
| |
| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 3 at Month 42 for participants from parent trial DEN-315. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
| |
| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 (Month 0 [Day 1]) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 1 at Month 0 for participants from both parent trials (DEN-304 and DEN-315). | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 0 [Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
|
| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 2 at Month 12 for participants from both parent trials (DEN-304 and DEN-315). | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
|
| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 3 at Month 15 for participants from parent trial DEN-304. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 15 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). |
| |
| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 3 at Month 42 for participants from parent trial DEN-315. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
| |
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 1 at Month 0 for participants from both parent trials (DEN-304 and DEN-315). | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 0 (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
| |
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 2 at Month 12 for participants from both parent trials (DEN-304 and DEN-315). | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
| |
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | Seropositivity Rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 15 for participants from parent trial DEN-304. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 15 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). |
| |
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 42 for parent trial DEN-315. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
| |
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 [Month 0 (Day 1]) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 1 at Month 0 for participants from both parent trials (DEN-304 and DEN-315). | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 0 (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 2 at Month 12 for participants from both parent trials (DEN-304 and DEN-315). | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 15 for participants from parent trial DEN-304. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 15 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). |
| |
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) ((DEN-315) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 42 for parent trial DEN-315. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
| |
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 1 at Month 0 for both parent trials (DEN-304 and DEN-315). | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 0 (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
|
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 2 at Month 12 for both parent trials (DEN-304 and DEN-315). | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
|
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 15 for parent trial DEN-304. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 15 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). |
| |
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 42 for parent trial DEN-315. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
| |
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 (Month 0 [Day 1]) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 1 at Month 0 for both parent trials (DEN-304 and DEN-315). | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 0 (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
|
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 2 at Month 12 for both parent trials (DEN-304 and DEN-315). | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | |
|
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. (DEN-304). All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 15 for parent trial DEN-304. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 15 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). |
| |
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 42 for parent trial DEN-315. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Month 42 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 3, pre-booster dose for all participants (Month 15 for parent trial DEN-304 and Month 42 for parent trial DEN-315). Pre-booster dose is defined as the last non-missing value before booster administration. | Per Protocol Set-Booster (PPS-B) included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Pre-booster dose at Month 15 (DEN-304) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 1 month post-booster dose at Month 16 (DEN-304) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Pre-booster dose at Month 42 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 1 month post-booster dose at Month 43 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 3, pre-booster dose for all participants (Month 15 for parent trial DEN-304 and Month 42 for parent trial DEN-315). Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Pre-booster dose at Month 15 (DEN-304) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 1 month post-booster dose at Month 16 (DEN-304) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Pre-booster dose at Month 42 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 1 month post-booster dose at Month 43 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 5, 6 months post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 6 months post-booster dose at Month 21 (DEN-304) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 6 months post-booster dose at Month 48 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 5, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 6 months post-booster dose at Month 21 (DEN-304) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315) | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 6 months post-booster dose at Month 48 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3, pre-booster dose for all participants (Month 15 for parent trial DEN-304 and Month 42 for parent trial DEN-315). Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 15 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 16 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 43 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3, pre-booster dose for all participants (Month 15 for parent trial DEN-304 and Month 42 for parent trial DEN-315). Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 15 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 16 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 43 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV |
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| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-booster dose at Month 21 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-booster dose at Month 48 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 mL, injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trials DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-booster dose at Month 21 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV |
|
| Primary | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315) | Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-booster dose at Month 48 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV |
|
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3, pre-booster dose for all participants (Month 15 for parent trial DEN-304 and Month 42 for parent trial DEN-315). Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 |
|
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV |
|
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 15 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV |
|
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 16 (DEN-304.) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 43 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), \ any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3, pre-booster dose for all participants (Month 15 for parent trial DEN-304 and Month 42 for parent trial DEN-315). Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), \ any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), \ any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 15 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), \any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 16 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as the last non-missing value before booster administration. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-booster dose at Month 42 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 month post-booster dose at Month 43 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-booster dose at Month 21 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-booster Dose at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-Booster dose at Month 48 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | |
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| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
|
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-booster dose at Month 21 (DEN-304) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
|
| Primary | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315) | Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months post-Booster dose at Month 48 (DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Secondary | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | unitless ratio | | Month 12 vs Month 0, Month 15 (DEN-304) vs parent trial Month 4, Mont 42 (DEN315) vs parent trial Month 4, Month 0 vs parent trial Month 9, Month 12 vs parent trial Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
| |
| Secondary | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials Prior to the Booster Dose | The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. | PPS included all participants from the FAS who received two doses of Takeda's TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | unitless ratio | | Month 12 vs Month 0, Month 15 (DEN-304) vs parent trial Month 4, Month 42 (DEN315) vs parent trial Month 4, Month 0 vs parent trial Month 9, Month 12 vs parent trial Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
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| Secondary | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | unitless ratio | | Months (M) 1&6 post-booster dose in current trial vs M 4 in parent trials; post-booster M 6 vs post-booster M 1; post-booster M 1 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315); post-booster M 6 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315) | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
| |
| Secondary | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. | PPS-B included all participants from the FAS-B who received two doses of Takeda's TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number analyzed: number of participants with data available for analysis for the specified category. | Posted | | Geometric Mean | 95% Confidence Interval | unitless ratio | | Months (M) 1&6 post-booster dose in current trial vs M 4 in parent trials; post-booster M 1 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315); post-booster M 6 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315); post-booster M 6 vs post-booster M 1 | | | | ID | Title | Description |
|---|
| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Secondary | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post-Booster Vaccination | Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days post-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315). AEs were graded by the investigator in the following manner: Mild: Grade 1: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities. Relieved with or without symptomatic treatment; Moderate: Grade 2: Sufficient discomfort is present to cause interference with normal activity. Only partially relieved with symptomatic treatment; Severe: Grade 3: Extreme distress, causing significant impairment of functioning or incapacitation. Prevents normal everyday activities. Not relieved with symptomatic treatment. | Safety Set-Booster (SAF-B) included all participants who received at least one dose of Takeda's TDV in the parent trials and who received the trial vaccination in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | | percentage of participants | | Days 1 through 7 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315]) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 |
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| Secondary | Percentage of Participants With Solicited Systemic Adverse Events Within 14 Days Post-Booster Vaccination by Severity | Solicited systemic AEs are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days post-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315). AEs were graded by the investigator in the following manner: Mild: Grade 1: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities. Relieved with or without symptomatic treatment; Moderate: Grade 2: Sufficient discomfort is present to cause interference with normal activity. Only partially relieved with symptomatic treatment; Severe: Grade 3: Extreme distress, causing significant impairment of functioning or incapacitation. Prevents normal everyday activities. Not relieved with symptomatic treatment. | SAF-B included all participants who received at least one dose of Takeda's TDV in the parent trials and who received the trial vaccination in the current trial. Overall number of participants analyzed: number of participants with data available for analyses. | Posted | | Number | | percentage of participants | | Days 1 through 14 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315]) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV |
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| Secondary | Percentage of Participants With Any Unsolicited AEs in the Booster Phase | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine or placebo; it does not necessarily have to have a causal relationship with this treatment. | SAF-B included all participants who received at least one dose of Takeda's TDV in the parent trials and who received the trial vaccination in the current trial. | Posted | | Number | | percentage of participants | | Days 1 through 28 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315]) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Secondary | Percentage of Participants With Any Medically Attended AEs (MAAEs) in the Booster Phase | MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. | SAF-B included all participants who received at least one dose of Takeda's TDV in the parent trials and who received the trial vaccination in the current trial. | Posted | | Number | | percentage of participants | | Month 15 post-booster dose through Month 21 (DEN-304); Month 42 post-booster dose through Month 48 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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| Secondary | Percentage of Participants With Any Serious Adverse Events (SAEs) Prior to the Booster Dose | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine or placebo; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important event. | SAF included all participants who agreed to participate in the current trial, did not screen fail, and who received at least one dose of Takeda's TDV in the parent trials. | Posted | | Number | | percentage of participants | | Month 0 through Month 15 (DEN-304) and Month 42 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Prior to Booster: DEN-304 | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15). | | OG001 | Prior to Booster: DEN-315 | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42). |
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| Secondary | Percentage of Participants With Any SAEs in the Booster Phase | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine or placebo; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important event. | SAF-B included all participants who received at least one dose of Takeda's TDV in the parent trials and who received the trial vaccination in the current trial. | Posted | | Number | | percentage of participants | | Month 15 post-booster dose after vaccination through Month 21 (DEN-304); Month 42 post-booster dose after vaccination through Month 48 (DEN-315) | | | | ID | Title | Description |
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| OG000 | Booster Phase: Placebo | Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). | | OG001 | Booster Phase: TDV | Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico). |
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