Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
Takeda's Dengue Tetravalent Vaccine · 1 trial · 1 indication
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).
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).
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.
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.
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).
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).
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.
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, 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, 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, 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, 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, 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, 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, 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, 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
| Arm | Type | Description |
|---|---|---|
| Prior to Booster: DEN-304 | EXPERIMENTAL | Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Month 15. |
| Prior to Booster: DEN-315 | EXPERIMENTAL | Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Month 42. |
| Booster Phase: Placebo | PLACEBO_COMPARATOR | Participants received TDV placebo-matching 0.5 milliliters (ml) injection, subcutaneous (SC), once at Month 15 for participants from parent trial DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico). |
| Booster Phase: TDV | EXPERIMENTAL | Participants received TDV 0.5 ml, injection, SC, once at Month 15 for participants from parent trial DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico). |
| Name | Type | Description |
|---|---|---|
| Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) | BIOLOGICAL | TDV subcutaneous injection |
| Placebo | BIOLOGICAL | Normal Saline (0.9% NaCl) subcutaneous injection |
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 l...