Dengue Fever
Conditions
Keywords
Vaccine
Brief summary
The purpose of this study is to describe antibody persistence for each of the 4 dengue serotypes for up to 63 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-315 (NCT03341637) (Mexico) and for up to 36 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-304 (NCT03423173) (United States \[US\]) and to describe the impact of a tetravalent dengue vaccine (TDV) booster dose vs placebo on antibody response for each of the 4 dengue serotypes at 1 month and 6 months post administration of the TDV booster or placebo.
Detailed description
The vaccine tested in this study is Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV). This study will look at the long-term antibody persistence and safety of Takeda's TDV in healthy adolescents and adults and will assess the impact of a booster dose. The study has enrolled 365 healthy participants. Participants who previously received TDV in two parent trials (DEN-304 \[NCT03423173\] and DEN-315 \[NCT03341637\]), will be invited to participate in this follow-up trial. Participants will be assessed for antibody persistence and safety from Baseline (Month 0) through Month 15 (for participants from parent trial DEN-304 \[US\]) or Month 42 (for participants from parent trial DEN-315 \[Mexico\]). At Month 15 (for participants from parent trial DEN-304 \[US\]) or at Month 42 (for participants from parent trial DEN-315 \[Mexico\]), eligible participants will be randomized in 1:1 ratio to one of two trial groups to receive TDV or placebo: A. Group 1- TDV 0.5 mL subcutaneous (SC) injection at Month 15 for participants from parent trial DEN-304 (US) or at Month 42 for participants from parent trial DEN-315 (Mexico\]). B. Group 2- Takeda's tetravalent dengue placebo (dummy SC injection - this is a liquid that looks like the study drug but has no active ingredient), 0.5 mL, subcutaneous injection at Month 15 for participants from parent trial DEN-304 (US) or at Month 42 for participants from parent trial DEN-315 (Mexico). This multi-centre trial will be conducted in US and Mexico. The overall time to participate in this study is up to 21 months for parent trial DEN-304 (US) and up to 48 months for parent trial DEN-315 (Mexico). Participants from parent trial DEN-304 (US) and participants from parent trial DEN-315 (Mexico) will come for 5 visits to the clinic which includes a final visit (Visit 5) 6 months after the booster dose for a follow-up assessment.
Interventions
BIOLOGICALTakeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
TDV subcutaneous injection
BIOLOGICALPlacebo
Normal Saline (0.9% NaCl) subcutaneous injection
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study will be double-blinded, randomized, and placebo-controlled from Month 15 onwards for participants from parent trial DEN-304 (US) and from Month 42 onwards for participants from parent trial DEN-315 (Mexico).
Eligibility
Sex/Gender
ALL
Age
13 Years to 63 Years
Healthy volunteers
Yes
Inclusion criteria
1\. Male or female participants (irrespective of serostatus at baseline in the parent trials (DEN-304 \[(NCT03423173)\] and DEN-315 \[NCT03341637\]) who received at least one dose of Takeda's tetravalent dengue vaccine candidate (TDV) in the parent trials and have data from at least one blood draw post-vaccination.
Exclusion criteria
1. Participants with a prolonged period of habitation (≥1 year) in a dengue endemic area within the 2 years prior to Visit 1 Day 1 (Month 0). 2. Previous and planned vaccination (during the trial conduct), against any flavivirus including dengue (other than Takeda's TDV), yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis. Booster
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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]) | 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). |
| 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) | 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). |
| 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) | 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. |
| 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) | 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. |
| 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]) | 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). |
| 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) | 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). |
| 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) | 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. |
| 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) | 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. |
| Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 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). |
| Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | 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). |
| Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | 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. |
| Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | 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. |
| 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]) | 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). |
| 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) | 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). |
| 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) | 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. |
| 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) | 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. |
| Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 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). |
| Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | 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). |
| Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | 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. |
| Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | 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. |
| 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]) | 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). |
| 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) | 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). |
| 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) | 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. |
| 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) | 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. |
| GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | Pre-booster dose at Month 15 (DEN-304) and 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, 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. |
| GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | 1 month post-booster dose at Month 16 (DEN-304) and 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, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). |
| GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | 6 months post-booster dose at Month 21 (DEN-304) and 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, 6 months post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). |
| GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | Pre-booster dose at 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. |
| GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | 1 month post-booster dose at 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. |
| GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | 6 months post-booster dose at 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. |
| GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | Pre-booster dose at 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. |
| GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | 1 month post-booster dose at 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. |
| GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | 6 months post-booster dose at 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. |
| 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 | Pre-booster dose at Month 15 (DEN-304) and 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, 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. |
| 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 | 1 month post-booster dose at Month 16 (DEN-304) and 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, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). |
| 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 | 6 months post-booster dose at Month 21 (DEN-304) and 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, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). |
| 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) | Pre-booster dose at 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. |
| 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) | 1 month post-booster dose at 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. |
| 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) | 6 months post-booster dose at 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. |
| 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) | Pre-booster dose at 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. |
| 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) | 1 month post-booster dose at 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. |
| 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) | 6 months post-booster dose at 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. |
| Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | Pre-booster dose at Month 15 (DEN-304) and 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, 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. |
| Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | 1 month post-booster dose at Month 16 (DEN-304) and 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, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). |
| Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | 6 months post-booster dose at Month 21 (DEN-304) and 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, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). |
| Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | Pre-booster dose at 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. |
| Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | 1 month post-booster dose at 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. |
| Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | 6 months post-booster dose at 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. |
| Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | Pre-booster dose at 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. |
| Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | 1 month post-booster dose at 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. |
| Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | 6 months post-booster dose at 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. |
| 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 | Pre-booster dose at Month 15 (DEN-304) and 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, 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. |
| 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 | 1 month post-booster dose at Month 16 (DEN-304) and 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, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). |
| 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 | 6 months post-booster dose at Month 21 (DEN-304) and 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, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). |
| 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) | Pre-booster dose at 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. |
| 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) | 1 month post-booster dose at 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. |
| 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) | 6 months post-booster dose at 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. |
| 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) | Pre-booster dose at 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. |
| 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) | 1 month post-booster dose at 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. |
| 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) | 6 months post-booster dose at 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. |
| Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | Pre-booster dose at Month 15 (DEN-304) and 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, 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. |
| Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | 1 month post-booster dose at Month 16 (DEN-304) and 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, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). |
| 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 | 6 months post-booster dose at Month 21 (DEN-304) and 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, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). |
| Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | Pre-booster dose at 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. |
| Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | 1 month post-booster dose at 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. |
| 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) | 6 months post-booster dose at 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. |
| Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | Pre-booster dose at 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. |
| 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) | 1 month post-booster dose at 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. |
| 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) | 6 months post-Booster dose at 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. |
| 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 | Pre-booster dose at Month 15 (DEN-304) and 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, 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. |
| 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 | 1 month post-booster dose at Month 16 (DEN-304) and 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, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). |
| 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 | 6 months post-booster dose at Month 21 (DEN-304) and 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, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). |
| 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) | Pre-booster dose at 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. |
| 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) | 1 month post-booster dose at 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. |
| 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) | 6 months post-booster dose at 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. |
| 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) | Pre-booster dose at 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. |
| 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) | 1 month post-booster dose at 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. |
| 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) | 6 months post-Booster dose at 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | 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 | The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. |
| 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 | 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 | 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. |
| GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | 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) | The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. |
| GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | 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 | 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. |
| Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post-Booster Vaccination | Days 1 through 7 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315]) | 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. |
| Percentage of Participants With Solicited Systemic Adverse Events Within 14 Days Post-Booster Vaccination by Severity | Days 1 through 14 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315]) | 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. |
| Percentage of Participants With Any Unsolicited AEs in the Booster Phase | Days 1 through 28 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315]) | 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. |
| Percentage of Participants With Any Medically Attended AEs (MAAEs) in the Booster Phase | Month 15 post-booster dose through Month 21 (DEN-304); Month 42 post-booster dose through Month 48 (DEN-315) | 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. |
| Percentage of Participants With Any Serious Adverse Events (SAEs) Prior to the Booster Dose | Month 0 through Month 15 (DEN-304) and Month 42 (DEN-315) | 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. |
| Percentage of Participants With Any SAEs in the Booster Phase | Month 15 post-booster dose after vaccination through Month 21 (DEN-304); Month 42 post-booster dose after vaccination through Month 48 (DEN-315) | 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. |
Countries
Mexico, United States
Contacts
STUDY_DIRECTORMedical Director
Takeda
Participant flow
Recruitment details
Participants took part in the study at multiple investigative sites in United States (US) and Mexico from 12 November 2019 to 25 May 2024.
Pre-assignment details
Healthy participants who received Takeda's Dengue Tetravalent Vaccine (TDV) in two parent trials, DEN-304 \[NCT03423173\] and DEN-315 \[NCT03341637\] were enrolled to receive either placebo or TDV.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 246 |
| 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). | 119 |
| Total | 365 |
Baseline characteristics
| Characteristic | Prior to Booster: DEN-315 | Total | Prior to Booster: DEN-304 |
|---|---|---|---|
| Age, Continuous | 16.3 years STANDARD_DEVIATION 1.77 | 35.2 years STANDARD_DEVIATION 16.01 | 44.4 years STANDARD_DEVIATION 11.03 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 119 Participants | 127 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 238 Participants | 238 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 35 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 117 Participants | 121 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 201 Participants | 201 Participants |
| Sex: Female, Male Female | 70 Participants | 215 Participants | 145 Participants |
| Sex: Female, Male Male | 49 Participants | 150 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 246 | 1 / 119 | 0 / 115 | 0 / 118 |
| other Total, other adverse events | 0 / 246 | 0 / 119 | 83 / 115 | 57 / 118 |
| serious Total, serious adverse events | 6 / 246 | 8 / 119 | 0 / 115 | 3 / 118 |
Outcome results
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).
Time frame: Month 0 (Day 1)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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]) | DENV-1 | 76.8 titer |
| Prior to Booster: DEN-304 | 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]) | DENV-2 | 539.6 titer |
| Prior to Booster: DEN-304 | 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]) | DENV-3 | 33.7 titer |
| Prior to Booster: DEN-304 | 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]) | DENV-4 | 40.0 titer |
| Prior to Booster: DEN-315 | 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]) | DENV-4 | 27.1 titer |
| Prior to Booster: DEN-315 | 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]) | DENV-1 | 88.6 titer |
| Prior to Booster: DEN-315 | 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]) | DENV-3 | 29.5 titer |
| Prior to Booster: DEN-315 | 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]) | DENV-2 | 425.6 titer |
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).
Time frame: Month 12
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | DENV-1 | 58.4 titer |
| Prior to Booster: DEN-304 | 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) | DENV-2 | 427.3 titer |
| Prior to Booster: DEN-304 | 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) | DENV-3 | 32.8 titer |
| Prior to Booster: DEN-304 | 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) | DENV-4 | 30.0 titer |
| Prior to Booster: DEN-315 | 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) | DENV-4 | 22.9 titer |
| Prior to Booster: DEN-315 | 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) | DENV-1 | 96.4 titer |
| Prior to Booster: DEN-315 | 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) | DENV-3 | 25.3 titer |
| Prior to Booster: DEN-315 | 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) | DENV-2 | 276.1 titer |
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.
Time frame: Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | DENV-1 | 121.7 titer |
| Prior to Booster: DEN-304 | 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) | DENV-2 | 560.2 titer |
| Prior to Booster: DEN-304 | 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) | DENV-3 | 40.3 titer |
| Prior to Booster: DEN-304 | 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) | DENV-4 | 34.1 titer |
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.
Time frame: Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | DENV-1 | 106.5 titer |
| Prior to Booster: DEN-304 | 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) | DENV-2 | 202.9 titer |
| Prior to Booster: DEN-304 | 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) | DENV-3 | 21.9 titer |
| Prior to Booster: DEN-304 | 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) | DENV-4 | 11.2 titer |
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).
Time frame: Month 0 [Day 1)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Positive: DENV-1 | 122.8 titer |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Positive: DENV-2 | 560.1 titer |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Positive: DENV-3 | 48.2 titer |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Positive: DENV-4 | 61.5 titer |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-1 | 71.3 titer |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-2 | 536.4 titer |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-3 | 31.8 titer |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-4 | 37.3 titer |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-4 | 24.5 titer |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Positive: DENV-1 | 259.3 titer |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-1 | 82.0 titer |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Positive: DENV-2 | 714.1 titer |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-3 | 26.7 titer |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Positive: DENV-3 | 118.7 titer |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-2 | 410.0 titer |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Positive: DENV-4 | 112.4 titer |
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).
Time frame: Month 12
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-1 | 87.2 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-2 | 544.5 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-3 | 48.6 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-4 | 48.0 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-1 | 54.8 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-2 | 411.1 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-3 | 30.8 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-4 | 27.8 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-4 | 23.0 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-1 | 93.5 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-1 | 96.5 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-2 | 272.6 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-3 | 25.0 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-3 | 34.0 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-2 | 276.2 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-4 | 21.5 titer |
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.
Time frame: Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-1 | 214.3 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-2 | 484.5 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-3 | 60.4 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-4 | 47.0 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-1 | 110.9 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-2 | 573.6 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-3 | 37.7 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-4 | 32.4 titer |
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.
Time frame: Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-1 | 320.0 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-2 | 436.6 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-3 | 80.4 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-4 | 23.3 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-1 | 95.8 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-2 | 188.6 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-3 | 19.3 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-4 | 10.4 titer |
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).
Time frame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-1 | 110.8 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-2 | 363.4 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-3 | 27.7 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-4 | 20.0 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-4 | 273.5 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-1 | 1438.3 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-3 | 446.5 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-2 | 1038.8 titer |
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.
Time frame: 1 month post-booster dose at Month 16 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-1 | 120.1 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-2 | 499.2 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-3 | 30.6 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-4 | 29.4 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-4 | 260.9 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-1 | 1254.3 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-3 | 389.7 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-2 | 1121.4 titer |
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.
Time frame: 1 month post-booster dose at Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-3 | 24.0 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-2 | 227.5 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-4 | 11.3 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-1 | 98.4 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-4 | 295.3 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-2 | 917.6 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-3 | 556.8 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-1 | 1795.8 titer |
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).
Time frame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 170.5 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 264.2 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 46.2 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 34.4 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 104.4 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 379.8 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 25.8 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 18.6 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 283.9 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 1192.5 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 1473.2 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 1533.3 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 472.6 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 286.5 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 988.3 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 204.2 titer |
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.
Time frame: 1 month post-booster dose at Month 16 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 125.6 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 264.3 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 29.3 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 29.8 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 119.2 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 559.8 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 30.8 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 29.4 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 271.1 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 1124.7 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 1275.5 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 1545.0 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 420.1 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 239.1 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 1067.4 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 202.8 titer |
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.
Time frame: 1 month post-booster dose at Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 427.0 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 264.1 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 180.8 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 53.0 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 87.3 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 224.8 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 20.4 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 10.0 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 304.5 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 1393.8 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 1836.5 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 1502.5 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 565.8 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 464.2 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 878.5 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 208.0 titer |
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).
Time frame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-1 | 94.2 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-2 | 305.2 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-3 | 27.4 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-4 | 16.7 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-4 | 87.5 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-1 | 464.9 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-3 | 159.5 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-2 | 552.5 titer |
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.
Time frame: 6 months post-booster dose at Month 21 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-1 | 107.8 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-2 | 433.0 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-3 | 30.7 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-4 | 24.3 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-4 | 89.2 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-1 | 410.9 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-3 | 133.5 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-2 | 689.4 titer |
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.
Time frame: 6 months post-booster dose at Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-1 | 78.0 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-2 | 187.0 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-3 | 23.5 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-4 | 9.9 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-4 | 85.0 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-1 | 553.9 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-3 | 205.2 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-2 | 403.4 titer |
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).
Time frame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 166.2 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 278.9 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 39.0 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 22.0 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 88.2 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 308.4 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 26.3 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 16.2 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 88.1 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 435.8 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 469.4 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 699.2 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 163.1 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 137.1 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 533.4 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 83.6 titer |
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.
Time frame: 6 months post-booster dose at Month 21 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 154.2 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 101.6 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 451.4 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 37.5 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 29.7 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 337.6 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 24.8 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 21.7 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 88.0 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 461.7 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 825.4 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 145.5 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 95.7 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 665.0 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 131.3 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 401.4 titer |
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.
Time frame: 6 months post-booster dose at Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 223.9 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 129.9 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 45.5 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 23.2 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 73.8 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 190.6 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 22.7 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 9.4 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 88.2 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 366.4 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 573.9 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 425.0 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 215.7 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 114.5 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 401.6 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 55.8 titer |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-1 | 116.2 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-2 | 404.0 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-3 | 32.3 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-4 | 20.8 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-4 | 21.4 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-1 | 120.7 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-3 | 30.1 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-2 | 361.7 titer |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-1 | 126.4 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-2 | 583.9 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-3 | 36.9 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-4 | 31.3 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-4 | 29.9 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-1 | 130.6 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-3 | 39.5 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-2 | 596.6 titer |
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.
Time frame: Pre-booster dose at Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-1 | 102.6 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-2 | 233.5 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-3 | 26.4 titer |
| Prior to Booster: DEN-304 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-4 | 11.3 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-4 | 12.7 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-1 | 106.7 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-3 | 19.6 titer |
| Prior to Booster: DEN-315 | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-2 | 165.4 titer |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 165.0 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 353.6 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 53.8 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 27.7 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 110.4 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 411.9 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 30.0 titer |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 20.0 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 19.4 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 310.4 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 106.1 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 771.3 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 26.0 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 88.8 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 326.2 titer |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 43.5 titer |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 120.5 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 368.8 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 39.4 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 22.9 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 127.6 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 639.0 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 36.4 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 33.3 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 26.5 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 368.4 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 109.2 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 839.4 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 33.6 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 102.1 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 562.4 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 59.1 titer |
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.
Time frame: Pre-booster dose at Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 151.1 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 52.5 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 91.0 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 228.5 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 23.0 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 10.0 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 470.4 titer |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 307.1 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 598.4 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 58.2 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 17.9 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 17.2 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 185.7 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 101.9 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 12.3 titer |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 148.6 titer |
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).
Time frame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-1 | 98.0 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-3 | 71.7 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-4 | 66.7 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-4 | 100 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | DENV-2 | 100 percentage of participants |
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.
Time frame: 1 month post-booster dose at Month 16 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-1 | 98.3 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-3 | 74.6 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-4 | 76.3 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-4 | 100 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | DENV-2 | 100 percentage of participants |
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.
Time frame: 1 month post-booster dose at Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-1 | 97.5 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-3 | 67.5 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-4 | 52.5 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-4 | 100 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) | DENV-2 | 100 percentage of participants |
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).
Time frame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 91.7 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 83.3 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 98.9 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 70.1 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 62.1 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 100 percentage of participants |
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.
Time frame: 1 month post-booster dose at Month 16 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 88.9 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 77.8 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 74.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 72.0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 100 percentage of participants |
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.
Time frame: 1 month post-booster dose at Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 97.3 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 64.9 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 48.6 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 100 percentage of participants |
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).
Time frame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-1 | 90.6 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-3 | 76.0 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-4 | 63.5 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-4 | 94.6 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-1 | 96.7 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-3 | 98.9 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials | DENV-2 | 100 percentage of participants |
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.
Time frame: 6 months post-booster dose at Month 21 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-1 | 89.3 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-3 | 78.6 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-4 | 71.4 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-4 | 96.3 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-1 | 96.3 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-3 | 98.1 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) | DENV-2 | 100 percentage of participants |
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.
Time frame: 6 months post-booster dose at Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-1 | 92.5 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-3 | 72.5 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-4 | 52.5 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-4 | 92.1 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-1 | 97.4 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) | DENV-2 | 100 percentage of participants |
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).
Time frame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 90.0 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 90.0 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 90.0 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 90.7 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 74.4 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 60.5 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 96.3 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 91.7 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 97.5 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 91.7 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 83.3 percentage of participants |
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.
Time frame: 6 months post-booster dose at Month 21 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 87.5 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 87.5 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 87.5 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 89.6 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 77.1 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 68.8 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 97.8 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 88.9 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 97.8 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 88.9 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 88.9 percentage of participants |
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.
Time frame: 6 months post-booster dose at Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 92.1 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 71.1 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 50.0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 94.3 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 97.1 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 66.7 percentage of participants |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-1 | 98.0 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-3 | 80.4 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-4 | 66.7 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-4 | 67.0 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-1 | 94.0 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-3 | 73.0 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | DENV-2 | 99.0 percentage of participants |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-1 | 96.7 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-3 | 83.6 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-4 | 75.4 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-4 | 72.1 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-1 | 95.1 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-3 | 77.0 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | DENV-2 | 100 percentage of participants |
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.
Time frame: Pre-booster dose at Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-3 | 75.6 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-4 | 53.7 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-4 | 59.0 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-1 | 92.3 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-3 | 66.7 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | DENV-2 | 97.4 percentage of participants |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 92.3 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 92.3 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 84.6 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 98.9 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 78.7 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 64.0 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-4 | 67.0 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-1 | 91.7 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-1 | 94.3 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-3 | 71.6 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-3 | 83.3 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Negative: DENV-2 | 98.9 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus;Positive: DENV-4 | 66.7 percentage of participants |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 90.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 90.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 80.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 98.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 82.4 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 74.5 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 71.2 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 88.9 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 96.2 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 76.9 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 77.8 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 77.8 percentage of participants |
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.
Time frame: Pre-booster dose at Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 73.7 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 50.0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-4 | 61.1 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-1 | 91.7 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-3 | 63.9 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 97.2 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive: DENV-4 | 33.3 percentage of participants |
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).
Time frame: Month 0 (Day 1)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | DENV-1 | 85.8 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | DENV-2 | 98.7 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | DENV-3 | 72.4 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | DENV-4 | 80.8 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | DENV-4 | 76.5 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | DENV-1 | 92.4 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | DENV-3 | 79.8 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | DENV-2 | 99.2 percentage of participants |
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).
Time frame: Month 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | DENV-1 | 78.6 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | DENV-3 | 72.0 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | DENV-4 | 76.4 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | DENV-1 | 97.9 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | DENV-4 | 83.3 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | DENV-3 | 75.0 percentage of participants |
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.
Time frame: Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | DENV-1 | 94.2 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | DENV-2 | 99.4 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | DENV-3 | 81.9 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | DENV-4 | 76.0 percentage of participants |
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.
Time frame: Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | DENV-1 | 96.3 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | DENV-2 | 98.8 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | DENV-3 | 71.3 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | DENV-4 | 55.0 percentage of participants |
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).
Time frame: Month 0 (Day 1)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Positive; DENV-1 | 81.8 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Positive; DENV-2 | 97.0 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Positive; DENV-3 | 75.8 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Positive; DENV-4 | 87.9 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-1 | 86.4 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-2 | 99.0 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-3 | 71.8 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-4 | 79.6 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-4 | 74.8 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Positive; DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-1 | 91.9 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Positive; DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-3 | 78.4 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Positive; DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Negative; DENV-2 | 99.1 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus:Positive; DENV-4 | 100 percentage of participants |
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).
Time frame: Month 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-1 | 80.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-3 | 76.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-4 | 80.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-1 | 78.3 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-3 | 71.3 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-4 | 75.8 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-4 | 82.6 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-1 | 97.8 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-3 | 73.9 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Negative; DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-4 | 100 percentage of participants |
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.
Time frame: Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-1 | 87.5 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive; DENV-3 | 83.3 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive: DENV-4 | 79.2 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative: DENV-1 | 95.2 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative: DENV-2 | 99.3 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative: DENV-3 | 81.6 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative: DENV-4 | 75.5 percentage of participants |
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.
Time frame: Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive: DENV-1 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive: DENV-2 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive: DENV-3 | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Positive: DENV-4 | 57.1 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus:Negative: DENV-1 | 95.9 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: DENV-2 | 98.6 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Negative:DENV-3 | 68.5 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Negative: DENV-4 | 54.8 percentage of participants |
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).
Time frame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | Bivalent | 18.2 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | Trivalent | 24.2 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | Tetravalent | 56.6 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials | Tetravalent | 100 percentage of participants |
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.
Time frame: 1 month post-booster dose at Month 16 (DEN-304.)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | Bivalent | 15.3 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | Trivalent | 20.3 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | Tetravalent | 64.4 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) | Tetravalent | 100 percentage of participants |
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).
Time frame: 1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Bivalent | 8.3 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Trivalent | 8.3 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Tetravalent | 83.3 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Bivalent | 19.5 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Trivalent | 26.4 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Tetravalent | 52.9 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Tetravalent | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Tetravalent | 100 percentage of participants |
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.
Time frame: 1 month post-booster dose at Month 16 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 11.1 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 11.1 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 77.8 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 16.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 22.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 62.0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 100 percentage of participants |
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.
Time frame: 1 month post-booster dose at Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 24.3 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 32.4 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 40.5 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 100 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 100 percentage of participants |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | Bivalent | 15.7 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | Trivalent | 20.6 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | Tetravalent | 62.7 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | Bivalent | 16.0 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | Trivalent | 20.0 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials | Tetravalent | 59.0 percentage of participants |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | Bivalent | 11.5 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | Trivalent | 16.4 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | Tetravalent | 70.5 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | Bivalent | 14.8 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | Trivalent | 16.4 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) | Tetravalent | 65.6 percentage of participants |
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.
Time frame: Pre-booster dose at Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | Bivalent | 22.0 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | Trivalent | 26.8 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | Tetravalent | 51.2 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | Bivalent | 17.9 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | Trivalent | 25.6 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) | Tetravalent | 48.7 percentage of participants |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Bivalent | 7.7 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Trivalent | 15.4 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Tetravalent | 76.9 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Bivalent | 16.9 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Trivalent | 21.3 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Tetravalent | 60.7 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Trivalent | 20.5 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Bivalent | 8.3 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Bivalent | 17.0 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Trivalent | 16.7 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Tetravalent | 58.0 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Tetravalent | 66.7 percentage of participants |
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.
Time frame: Pre-booster dose at Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 10.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 20.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 70.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 11.8 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 15.7 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 70.6 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 19.2 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 11.1 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 15.4 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 63.5 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 77.8 percentage of participants |
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.
Time frame: Pre-booster dose at Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 23.7 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 28.9 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 47.4 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 22.2 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 19.4 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 66.7 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 50.0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 33.3 percentage of participants |
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).
Time frame: Month 0 (Day 1)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | Bivalent | 10.9 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | Trivalent | 20.5 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | Tetravalent | 61.9 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | Bivalent | 9.2 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | Trivalent | 18.5 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) | Tetravalent | 67.2 percentage of participants |
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).
Time frame: Month 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | Bivalent | 12.6 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | Trivalent | 21.4 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | Tetravalent | 57.1 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | Bivalent | 10.4 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | Trivalent | 22.9 percentage of participants |
| Prior to Booster: DEN-315 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) | Tetravalent | 66.7 percentage of participants |
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.
Time frame: Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | Bivalent | 10.5 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | Trivalent | 17.0 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) | Tetravalent | 69.0 percentage of participants |
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.
Time frame: Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | Bivalent | 20.0 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | Trivalent | 27.5 percentage of participants |
| Prior to Booster: DEN-304 | Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) | Tetravalent | 48.8 percentage of participants |
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).
Time frame: Month 0 (Day 1)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus;Positive: Bivalent | 9.1 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus;Positive: Trivalent | 12.1 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus;Positive: Tetravalent | 69.7 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus;Negative: Bivalent | 11.2 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus;Negative: Trivalent | 21.8 percentage of participants |
| Prior to Booster: DEN-304 | 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]) | Parent Trial Baseline Serostatus;Negative: Tetravalent | 60.7 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus;Negative: Trivalent | 19.8 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus;Positive: Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus;Negative: Bivalent | 9.9 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus;Positive: Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus;Negative: Tetravalent | 64.9 percentage of participants |
| Prior to Booster: DEN-315 | 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]) | Parent Trial Baseline Serostatus;Positive: Tetravalent | 100 percentage of participants |
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).
Time frame: Month 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive:Bivalent | 4.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive:Trivalent | 20.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Positive:Tetravalent | 64.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative:Bivalent | 14.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: Trivalent | 21.7 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus;Negative: Tetravalent | 56.1 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: Trivalent | 23.9 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive:Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative:Bivalent | 10.9 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive:Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Negative: Tetravalent | 65.2 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus;Positive:Tetravalent | 100 percentage of participants |
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.
Time frame: Month 15 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Positive: Bivalent | 8.3 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Positive: Trivalent | 8.3 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Positive: Tetravalent | 75.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Negative: Bivalent | 10.9 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Negative: Trivalent | 18.4 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Negative: Tetravalent | 68.0 percentage of participants |
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.
Time frame: Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Positive: Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Positive: Trivalent | 42.9 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Positive: Tetravalent | 57.1 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Negative: Bivalent | 21.9 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Negative: Trivalent | 26.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus; Negative: Tetravalent | 47.9 percentage of participants |
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.
Time frame: 1 month post-booster dose at Month 43 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Bivalent | 22.5 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Trivalent | 30.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Tetravalent | 45.0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Tetravalent | 100 percentage of participants |
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).
Time frame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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 | Bivalent | 14.6 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Trivalent | 21.9 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Tetravalent | 57.3 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Bivalent | 2.2 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Trivalent | 5.4 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Tetravalent | 92.4 percentage of participants |
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.
Time frame: 6 months post-booster dose at Month 21 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Bivalent | 14.3 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Trivalent | 16.1 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Tetravalent | 64.3 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Bivalent | 1.9 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Trivalent | 5.6 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Tetravalent | 92.6 percentage of participants |
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.
Time frame: 6 months post-Booster dose at Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Bivalent | 15.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Trivalent | 30.0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Tetravalent | 47.5 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Bivalent | 2.6 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Trivalent | 5.3 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Tetravalent | 92.1 percentage of participants |
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).
Time frame: 6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Tetravalent | 90.0 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Bivalent | 16.3 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Trivalent | 24.4 percentage of participants |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Tetravalent | 53.5 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Trivalent | 3.8 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Bivalent | 8.3 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Bivalent | 1.3 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Trivalent | 16.7 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Tetravalent | 95.0 percentage of participants |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Tetravalent | 75.0 percentage of participants |
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.
Time frame: 6 months post-booster dose at Month 21 (DEN-304)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 87.5 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 16.7 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 18.8 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 60.4 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 4.4 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 11.1 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 11.1 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 95.6 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 77.8 percentage of participants |
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.
Time frame: 6 months post-Booster dose at Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 100 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 44.7 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 15.8 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 0 percentage of participants |
| Prior to Booster: DEN-304 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 31.6 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Trivalent | 33.3 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Tetravalent | 94.3 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Bivalent | 0 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Trivalent | 2.9 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Positive; Tetravalent | 66.7 percentage of participants |
| Prior to Booster: DEN-315 | 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) | Parent Trial Baseline Serostatus: Negative; Bivalent | 2.9 percentage of participants |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 0 vs Parent Trial Month 9: DENV-1 | 0.635 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Month 0: DENV-2 | 0.756 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Month 0: DENV-3 | 0.980 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Month 0: DENV-4 | 0.736 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 15 (DEN-304) vs Parent Trial Month 4: DENV-1 | 0.506 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 15 (DEN-304) vs Parent Trial Month 4: DENV-2 | 0.164 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 15 (DEN-304) vs Parent Trial Month 4: DENV-3 | 0.350 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 15 (DEN-304) vs Parent Trial Month 4: DENV-4 | 0.178 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Month 0: DENV-1 | 0.736 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 0 vs Parent Trial Month 9: DENV-2 | 0.469 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 0 vs Parent Trial Month 9: DENV-3 | 0.538 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 0 vs Parent Trial Month 9: DENV-4 | 0.710 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Parent Trial Month 9: DENV-1 | 0.497 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Parent Trial Month 9: DENV-2 | 0.311 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Parent Trial Month 9: DENV-3 | 0.561 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Parent Trial Month 9: DENV-4 | 0.577 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Month 0; DENV-1 | 0.756 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Month 0; DENV-2 | 0.689 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Month 0; DENV-3 | 0.847 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Month 0; DENV-4 | 0.681 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 15 (DEN-304) vs Parent Trial Month 4; DENV-1 | 0.427 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 15 (DEN-304) vs Parent Trial Month 4; DENV-2 | 0.158 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 15 (DEN-304) vs Parent Trial Month 4; DENV-3 | 0.265 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 15 (DEN-304) vs Parent Trial Month 4; DENV-4 | 0.223 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 0 vs Parent Trial Month 9; DENV-1 | 0.514 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 0 vs Parent Trial Month 9; DENV-2 | 0.385 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 0 vs Parent Trial Month 9; DENV-3 | 0.426 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 0 vs Parent Trial Month 9; DENV-4 | 0.557 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Parent Trial Month 9; DENV-1 | 0.403 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Parent Trial Month 9; DENV-2 | 0.259 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Parent Trial Month 9; DENV-3 | 0.387 unitless ratio |
| Prior to Booster: DEN-304 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Parent Trial Month 9; DENV-4 | 0.359 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Parent Trial Month 9; DENV-4 | 0.553 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Month 0: DENV-1 | 0.705 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Month 0; DENV-1 | 0.900 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Month 0: DENV-2 | 0.456 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 0 vs Parent Trial Month 9; DENV-1 | 0.516 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Month 0: DENV-3 | 1.000 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Month 0; DENV-2 | 0.630 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Month 0: DENV-4 | 0.727 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Parent Trial Month 9; DENV-1 | 0.492 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Month 0; DENV-3 | 0.846 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 0 vs Parent Trial Month 9; DENV-2 | 0.467 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Month 0; DENV-4 | 0.867 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 42 (DEN-315) vs Parent Trial Month 4: DENV-1 | 0.393 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 42 (DEN-315) vs Parent Trial Month 4: DENV-2 | 0.164 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 42 (DEN-315) vs Parent Trial Month 4: DENV-3 | 0.319 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 42 (DEN-315) vs Parent Trial Month 4: DENV-4 | 0.070 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Parent Trial Month 9; DENV-3 | 0.426 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 0 vs Parent Trial Month 9: DENV-1 | 0.528 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 0 vs Parent Trial Month 9; DENV-3 | 0.547 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 0 vs Parent Trial Month 9: DENV-2 | 0.454 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 12 vs Parent Trial Month 9; DENV-2 | 0.296 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 0 vs Parent Trial Month 9: DENV-3 | 0.556 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 0 vs Parent Trial Month 9; DENV-4 | 0.560 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 0 vs Parent Trial Month 9: DENV-4 | 0.684 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 42 (DEN-315) vs Parent Trial Month 4; DENV-1 | 0.288 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Parent Trial Month 9: DENV-1 | 0.375 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 42 (DEN-315) vs Parent Trial Month 4; DENV-2 | 0.103 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Parent Trial Month 9: DENV-2 | 0.172 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 42 (DEN-315) vs Parent Trial Month 4; DENV-3 | 0.192 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Parent Trial Month 9: DENV-3 | 0.664 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Negative; Month 42 (DEN-315) vs Parent Trial Month 4; DENV-4 | 0.065 unitless ratio |
| Prior to Booster: DEN-315 | 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 | Parent Trial Baseline Serostatus: Positive; Month 12 vs Parent Trial Month 9: DENV-4 | 0.966 unitless ratio |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Month 0: DENV-1 | 0.753 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 0 vs Parent Trial Month 9: DENV-1 | 0.529 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 15 (DEN-304) vs Parent Trial Month 4: DENV-1 | 0.438 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 0 vs Parent Trial Month 9: DENV-2 | 0.396 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 15 (DEN-304) vs Parent Trial Month 4: DENV-2 | 0.159 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 0 vs Parent Trial Month 9: DENV-3 | 0.440 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 15 (DEN-304) vs Parent Trial Month 4: DENV-3 | 0.275 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 0 vs Parent Trial Month 9: DENV-4 | 0.577 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 15 (DEN-304) vs Parent Trial Month 4: DENV-4 | 0.216 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Parent Trial Month 9: DENV-1 | 0.415 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Month 0: DENV-3 | 0.864 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Parent Trial Month 9: DENV-2 | 0.265 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Month 0: DENV-2 | 0.698 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Parent Trial Month 9: DENV-3 | 0.407 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Month 0: DENV-4 | 0.689 unitless ratio |
| Prior to Booster: DEN-304 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Parent Trial Month 9: DENV-4 | 0.384 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Parent Trial Month 9: DENV-4 | 0.567 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Month 0: DENV-1 | 0.891 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Month 0: DENV-2 | 0.622 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Month 0: DENV-3 | 0.852 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Month 0: DENV-4 | 0.861 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 42 (DEN-315) vs Parent Trial Month 4: DENV-1 | 0.296 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 42 (DEN-315) vs Parent Trial Month 4: DENV-2 | 0.108 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 42 (DEN-315) vs Parent Trial Month 4: DENV-3 | 0.202 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 42 (DEN-315) vs Parent Trial Month 4: DENV-4 | 0.066 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 0 vs Parent Trial Month 9: DENV-1 | 0.517 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 0 vs Parent Trial Month 9: DENV-2 | 0.466 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 0 vs Parent Trial Month 9: DENV-3 | 0.547 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 0 vs Parent Trial Month 9: DENV-4 | 0.568 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Parent Trial Month 9: DENV-1 | 0.486 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Parent Trial Month 9: DENV-2 | 0.289 unitless ratio |
| Prior to Booster: DEN-315 | Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose | Month 12 vs Parent Trial Month 9: DENV-3 | 0.435 unitless ratio |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Parent Trial Month 4: DENV-3 | 0.311 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Parent Trial Month 4; DENV-1 | 0.343 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Pre-booster dose: DENV-3 | 0.965 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Parent Trial Month 4; DENV-2 | 0.125 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Pre-booster dose: DENV-2 | 0.803 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Parent Trial Month 4; DENV-3 | 0.221 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Pre-booster dose: DENV-4 | 0.871 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Parent Trial Month 4; DENV-4 | 0.130 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Parent Trial Month 4: DENV-2 | 0.118 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Pre-booster dose; DENV-1 | 0.953 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Booster Month 1: DENV-1 | 0.998 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Pre-booster dose; DENV-2 | 0.956 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Pre-booster dose: DENV-3 | 0.825 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Pre-booster dose; DENV-3 | 0.860 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Booster Month 1: DENV-2 | 1.026 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Pre-booster dose; DENV-4 | 0.939 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Parent Trial Month 4: DENV-4 | 0.187 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Pre-booster dose; DENV-1 | 0.756 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Booster Month 1: DENV-3 | 1.024 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Pre-booster dose; DENV-2 | 0.766 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Pre-booster dose: DENV-4 | 1.310 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Pre-booster dose; DENV-3 | 0.846 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Booster Month 1: DENV-4 | 0.772 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Pre-booster dose; DENV-4 | 0.801 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Parent Trial Month 4: DENV-1 | 0.413 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Booster Month 1; DENV-1 | 0.799 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Parent Trial Month 4: DENV-1 | 0.400 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Booster Month 1; DENV-2 | 0.805 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Pre-booster dose: DENV-1 | 1.065 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Booster Month 1; DENV-3 | 0.986 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Parent Trial Month 4: DENV-2 | 0.103 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Booster Month 1; DENV-4 | 0.850 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Pre-booster dose: DENV-1 | 1.033 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Parent Trial Month 4; DENV-1 | 0.273 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Parent Trial Month 4:DENV-3 | 0.333 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Parent Trial Month 4; DENV-2 | 0.100 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Pre-booster dose: DENV-2 | 0.739 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Parent Trial Month 4; DENV-3 | 0.215 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Parent Trial Month 4: DENV-4 | 0.113 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Parent Trial Month 4; DENV-4 | 0.109 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Pre-booster dose; DENV-1 | 13.646 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Parent Trial Month 4: DENV-1 | 2.219 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Parent Trial Month 4: DENV-2 | 0.355 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Parent Trial Month 4: DENV-3 | 1.566 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Parent Trial Month 4: DENV-4 | 1.018 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Pre-booster dose: DENV-1 | 3.683 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Pre-booster dose: DENV-2 | 1.805 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Pre-booster dose: DENV-3 | 3.699 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 1 vs Pre-booster dose: DENV-4 | 5.895 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Pre-booster dose: DENV-1 | 1.404 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Pre-booster dose: DENV-2 | 0.906 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Pre-booster dose: DENV-3 | 1.544 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Pre-booster dose: DENV-4 | 1.923 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Booster Month 1: DENV-1 | 0.379 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Booster Month 1: DENV-2 | 0.506 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Booster Month 1: DENV-3 | 0.437 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Booster Month 1: DENV-4 | 0.349 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Parent Trial Month 4: DENV-1 | 0.779 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Parent Trial Month 4: DENV-2 | 0.161 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Parent Trial Month 4:DENV-3 | 0.593 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Positive; Booster Month 6 vs Parent Trial Month 4: DENV-4 | 0.314 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Parent Trial Month 4; DENV-1 | 4.692 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Parent Trial Month 4; DENV-2 | 0.382 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Parent Trial Month 4; DENV-3 | 3.322 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Parent Trial Month 4; DENV-4 | 1.585 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Parent Trial Month 4; DENV-4 | 0.498 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Pre-booster dose; DENV-2 | 2.988 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Pre-booster dose; DENV-3 | 17.792 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 1 vs Pre-booster dose; DENV-4 | 14.586 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Pre-booster dose; DENV-1 | 4.425 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Pre-booster dose; DENV-2 | 1.680 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Pre-booster dose; DENV-3 | 6.824 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Pre-booster dose; DENV-4 | 4.837 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Booster Month 1; DENV-1 | 0.328 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Booster Month 1; DENV-2 | 0.539 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Booster Month 1; DENV-3 | 0.361 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Booster Month 1; DENV-4 | 0.319 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Parent Trial Month 4; DENV-1 | 1.546 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Parent Trial Month 4; DENV-2 | 0.214 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase | Parent Trial Baseline Serostatus: Negative; Booster Month 6 vs Parent Trial Month 4; DENV-3 | 1.253 unitless ratio |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Parent Trial Month 4: DENV-3 | 0.231 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Booster Month 1: DENV-3 | 0.990 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Parent Trial Month 4: DENV-2 | 0.100 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Booster Month 1: DENV-4 | 0.842 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Parent Trial Month 4: DENV-2 | 0.124 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Pre-booster dose: DENV-1 | 0.962 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Parent Trial Month 4:DENV-3 | 0.225 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Pre-booster dose: DENV-2 | 0.936 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Parent Trial Month 4: DENV-4 | 0.136 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Pre-booster dose: DENV-3 | 0.856 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Parent Trial Month 4: DENV-4 | 0.110 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Pre-booster dose: DENV-4 | 0.977 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Parent Trial Month 4: DENV-1 | 0.352 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Pre-booster dose: DENV-1 | 0.784 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Booster Month 1: DENV-1 | 0.817 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Pre-booster dose: DENV-2 | 0.763 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Parent Trial Month 4: DENV-1 | 0.285 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Pre-booster dose: DENV-3 | 0.858 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Pre-booster dose: DENV-4 | 0.808 unitless ratio |
| Prior to Booster: DEN-304 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Booster Month 1: DENV-2 | 0.825 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Pre-booster dose: DENV-4 | 4.289 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Parent Trial Month 4: DENV-1 | 4.298 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Parent Trial Month 4: DENV-2 | 0.378 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Parent Trial Month 4: DENV-3 | 3.042 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Parent Trial Month 4: DENV-4 | 1.505 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Parent Trial Month 4: DENV-1 | 1.409 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Parent Trial Month 4: DENV-2 | 0.206 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Parent Trial Month 4:DENV-3 | 1.133 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Parent Trial Month 4: DENV-4 | 0.468 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Booster Month 1: DENV-1 | 0.334 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Booster Month 1: DENV-2 | 0.535 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Booster Month 1: DENV-3 | 0.370 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Booster Month 1: DENV-4 | 0.323 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Pre-booster dose: DENV-1 | 11.762 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Pre-booster dose: DENV-2 | 2.822 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Pre-booster dose: DENV-3 | 14.889 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 1 vs Pre-booster dose: DENV-4 | 13.162 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Pre-booster dose: DENV-1 | 3.810 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Pre-booster dose: DENV-2 | 1.550 unitless ratio |
| Prior to Booster: DEN-315 | GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase | Booster Month 6 vs Pre-booster dose: DENV-3 | 5.622 unitless ratio |
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.
Time frame: Month 15 post-booster dose through Month 21 (DEN-304); Month 42 post-booster dose through Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prior to Booster: DEN-304 | Percentage of Participants With Any Medically Attended AEs (MAAEs) in the Booster Phase | 16.9 percentage of participants |
| Prior to Booster: DEN-315 | Percentage of Participants With Any Medically Attended AEs (MAAEs) in the Booster Phase | 11.3 percentage of participants |
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.
Time frame: Month 15 post-booster dose after vaccination through Month 21 (DEN-304); Month 42 post-booster dose after vaccination through Month 48 (DEN-315)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prior to Booster: DEN-304 | Percentage of Participants With Any SAEs in the Booster Phase | 2.5 percentage of participants |
| Prior to Booster: DEN-315 | Percentage of Participants With Any SAEs in the Booster Phase | 0 percentage of participants |
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.
Time frame: Month 0 through Month 15 (DEN-304) and Month 42 (DEN-315)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prior to Booster: DEN-304 | Percentage of Participants With Any Serious Adverse Events (SAEs) Prior to the Booster Dose | 2.4 percentage of participants |
| Prior to Booster: DEN-315 | Percentage of Participants With Any Serious Adverse Events (SAEs) Prior to the Booster Dose | 6.7 percentage of participants |
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.
Time frame: Days 1 through 28 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315])
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prior to Booster: DEN-304 | Percentage of Participants With Any Unsolicited AEs in the Booster Phase | 6.8 percentage of participants |
| Prior to Booster: DEN-315 | Percentage of Participants With Any Unsolicited AEs in the Booster Phase | 6.1 percentage of participants |
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.
Time frame: Days 1 through 7 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post-Booster Vaccination | Mild | 17.4 percentage of participants |
| Prior to Booster: DEN-304 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post-Booster Vaccination | Moderate | 5.2 percentage of participants |
| Prior to Booster: DEN-304 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post-Booster Vaccination | Severe | 0 percentage of participants |
| Prior to Booster: DEN-315 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post-Booster Vaccination | Mild | 50.0 percentage of participants |
| Prior to Booster: DEN-315 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post-Booster Vaccination | Moderate | 14.3 percentage of participants |
| Prior to Booster: DEN-315 | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post-Booster Vaccination | Severe | 1.8 percentage of participants |
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.
Time frame: Days 1 through 14 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315])
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior to Booster: DEN-304 | Percentage of Participants With Solicited Systemic Adverse Events Within 14 Days Post-Booster Vaccination by Severity | Mild | 30.4 percentage of participants |
| Prior to Booster: DEN-304 | Percentage of Participants With Solicited Systemic Adverse Events Within 14 Days Post-Booster Vaccination by Severity | Moderate | 12.2 percentage of participants |
| Prior to Booster: DEN-304 | Percentage of Participants With Solicited Systemic Adverse Events Within 14 Days Post-Booster Vaccination by Severity | Severe | 1.7 percentage of participants |
| Prior to Booster: DEN-315 | Percentage of Participants With Solicited Systemic Adverse Events Within 14 Days Post-Booster Vaccination by Severity | Mild | 32.1 percentage of participants |
| Prior to Booster: DEN-315 | Percentage of Participants With Solicited Systemic Adverse Events Within 14 Days Post-Booster Vaccination by Severity | Moderate | 17.0 percentage of participants |
| Prior to Booster: DEN-315 | Percentage of Participants With Solicited Systemic Adverse Events Within 14 Days Post-Booster Vaccination by Severity | Severe | 3.6 percentage of participants |