Phase 3
N=365
Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
Dengue Fever
Bottom Line
View on ClinicalTrials.gov: NCT03999996 ↗Enrolled (actual)
365
Serious AEs
2.8%
Results posted
Jun 2025
Primary outcome: 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]) — 76.8; 88.6; 539.6; 425.6 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) (Biological); Placebo (Biological)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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]) |
76.8; 88.6; 539.6; 425.6; 33.7; 29.5 | — |
| 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) |
58.4; 96.4; 427.3; 276.1; 32.8; 25.3 | — |
| 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) |
121.7; 560.2; 40.3; 34.1 | — |
| 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) |
106.5; 202.9; 21.9; 11.2 | — |
| 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]) |
122.8; 259.3; 560.1; 714.1; 48.2; 118.7 | — |
| 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) |
87.2; 93.5; 544.5; 272.6; 48.6; 34.0 | — |
| 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) |
214.3; 484.5; 60.4; 47.0; 110.9; 573.6 | — |
| 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) |
320.0; 436.6; 80.4; 23.3; 95.8; 188.6 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) |
85.8; 92.4; 98.7; 99.2; 72.4; 79.8 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) |
78.6; 97.9; 100; 100; 72.0; 75.0 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) |
94.2; 99.4; 81.9; 76.0 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) |
96.3; 98.8; 71.3; 55.0 | — |
| 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]) |
81.8; 100; 97.0; 100; 75.8; 100 | — |
| 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) |
80.0; 100; 100; 100; 76.0; 100 | — |
| 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) |
87.5; 100; 83.3; 79.2; 95.2; 99.3 | — |
| 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) |
100; 100; 100; 57.1; 95.9; 98.6 | — |
| PRIMARY Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) |
10.9; 9.2; 20.5; 18.5; 61.9; 67.2 | — |
| PRIMARY Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) |
12.6; 10.4; 21.4; 22.9; 57.1; 66.7 | — |
| PRIMARY Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) |
10.5; 17.0; 69.0 | — |
| PRIMARY Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) |
20.0; 27.5; 48.8 | — |
| 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]) |
9.1; 0; 12.1; 0; 69.7; 100 | — |
| 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) |
4.0; 0; 20.0; 0; 64.0; 100 | — |
| 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) |
8.3; 8.3; 75.0; 10.9; 18.4; 68.0 | — |
| 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) |
0; 42.9; 57.1; 21.9; 26.0; 47.9 | — |
| PRIMARY GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials |
116.2; 120.7; 404.0; 361.7; 32.3; 30.1 | — |
| 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 |
110.8; 1438.3; 363.4; 1038.8; 27.7; 446.5 | — |
| PRIMARY GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) |
126.4; 130.6; 583.9; 596.6; 36.9; 39.5 | — |
| 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) |
120.1; 1254.3; 499.2; 1121.4; 30.6; 389.7 | — |
| PRIMARY GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) |
102.6; 106.7; 233.5; 165.4; 26.4; 19.6 | — |
| 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) |
98.4; 1795.8; 227.5; 917.6; 24.0; 556.8 | — |
| 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 |
165.0; 310.4; 353.6; 771.3; 53.8; 88.8 | — |
| 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 |
170.5; 1192.5; 264.2; 1533.3; 46.2; 286.5 | — |
| 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) |
120.5; 368.4; 368.8; 839.4; 39.4; 102.1 | — |
| 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) |
125.6; 1124.7; 264.3; 1545.0; 29.3; 239.1 | — |
| 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) |
470.4; 185.7; 307.1; 598.4; 151.1; 58.2 | — |
| 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) |
427.0; 1393.8; 264.1; 1502.5; 180.8; 464.2 | — |
| 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 |
94.2; 464.9; 305.2; 552.5; 27.4; 159.5 | — |
| 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) |
107.8; 410.9; 433.0; 689.4; 30.7; 133.5 | — |
| 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) |
78.0; 553.9; 187.0; 403.4; 23.5; 205.2 | — |
| 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 |
166.2; 435.8; 278.9; 699.2; 39.0; 137.1 | — |
| 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) |
154.2; 461.7; 337.6; 825.4; 37.5; 145.5 | — |
| 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) |
223.9; 366.4; 129.9; 425.0; 45.5; 114.5 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials |
98.0; 94.0; 100; 99.0; 80.4; 73.0 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials |
98.0; 100; 100; 100; 71.7; 100 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) |
96.7; 95.1; 100; 100; 83.6; 77.0 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) |
98.3; 100; 100; 100; 74.6; 100 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) |
100; 92.3; 100; 97.4; 75.6; 66.7 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) |
97.5; 100; 100; 100; 67.5; 100 | — |
| 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 |
92.3; 91.7; 100; 100; 92.3; 83.3 | — |
| 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 |
91.7; 100; 100; 100; 83.3; 100 | — |
| 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) |
90.0; 88.9; 100; 100; 90.0; 77.8 | — |
| 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) |
88.9; 100; 100; 100; 77.8; 100 | — |
| 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) |
100; 100; 100; 100; 100; 100 | — |
| 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) |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials |
90.6; 96.7; 100; 100; 76.0; 98.9 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) |
89.3; 96.3; 100; 100; 78.6; 98.1 | — |
| PRIMARY Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) |
92.5; 97.4; 100; 100; 72.5; 100 | — |
| 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 |
90.0; 91.7; 100; 100; 90.0; 91.7 | — |
| 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) |
87.5; 88.9; 100; 100; 87.5; 88.9 | — |
| 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) |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials |
15.7; 16.0; 20.6; 20.0; 62.7; 59.0 | — |
| PRIMARY Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials |
18.2; 0; 24.2; 0; 56.6; 100 | — |
| PRIMARY Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) |
11.5; 14.8; 16.4; 16.4; 70.5; 65.6 | — |
| PRIMARY Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) |
15.3; 0; 20.3; 0; 64.4; 100 | — |
| PRIMARY Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) |
22.0; 17.9; 26.8; 25.6; 51.2; 48.7 | — |
| 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) |
22.5; 0; 30.0; 0; 45.0; 100 | — |
| 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 |
7.7; 8.3; 15.4; 16.7; 76.9; 66.7 | — |
| 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 |
8.3; 0; 8.3; 0; 83.3; 100 | — |
| 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) |
10.0; 11.1; 20.0; 0; 70.0; 77.8 | — |
| 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) |
11.1; 0; 11.1; 0; 77.8; 100 | — |
| 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) |
0; 0; 0; 66.7; 100; 33.3 | — |
| 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) |
0; 0; 0; 0; 100; 100 | — |
| 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 |
14.6; 2.2; 21.9; 5.4; 57.3; 92.4 | — |
| 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) |
14.3; 1.9; 16.1; 5.6; 64.3; 92.6 | — |
| 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) |
15.0; 2.6; 30.0; 5.3; 47.5; 92.1 | — |
| 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 |
0; 8.3; 0; 16.7; 90.0; 75.0 | — |
| 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) |
0; 11.1; 0; 11.1; 87.5; 77.8 | — |
| 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) |
0; 0; 0; 33.3; 100; 66.7 | — |
| SECONDARY Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for All Participants Prior to the Booster Dose |
0.753; 0.891; 0.698; 0.622; 0.864; 0.852 | — |
| 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 |
0.736; 0.705; 0.756; 0.456; 0.980; 1.000 | — |
| SECONDARY GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase |
0.352; 4.298; 0.124; 0.378; 0.231; 3.042 | — |
| SECONDARY GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase |
0.413; 2.219; 0.118; 0.355; 0.311; 1.566 | — |
| SECONDARY Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post-Booster Vaccination |
17.4; 50.0; 5.2; 14.3; 0; 1.8 | — |
| SECONDARY Percentage of Participants With Solicited Systemic Adverse Events Within 14 Days Post-Booster Vaccination by Severity |
30.4; 32.1; 12.2; 17.0; 1.7; 3.6 | — |
| SECONDARY Percentage of Participants With Any Unsolicited AEs in the Booster Phase |
6.8; 6.1 | — |
| SECONDARY Percentage of Participants With Any Medically Attended AEs (MAAEs) in the Booster Phase |
16.9; 11.3 | — |
| SECONDARY Percentage of Participants With Any Serious Adverse Events (SAEs) Prior to the Booster Dose |
2.4; 6.7 | — |
| SECONDARY Percentage of Participants With Any SAEs in the Booster Phase |
2.5; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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).
- 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 Exclusion Criteria:
- Participants for whom baseline serostatus is not defined in the parent trials (DEN-304 [(NCT03423173)] and DEN-315 [NCT03341637]).
- Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (eg, Guillain-Barré syndrome).
- Known or suspected impairment/alteration of immune function, including:
- Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US); use of inhaled, intranasal, or topical corticosteroids is allowed.
- Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US).
- Administration of immunoglobulins and/or any blood products within the 3 months prior to administration of the TDV booster or placebo at Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US); consider whether applicable as an exclusion criterion or criterion for delay.
- Receipt of immunostimulants within 60 days prior to Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US).
- Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Month 42 for participants from parent trial DEN-315 (Mexico) / Month 15 for participants from parent trial DEN-304 (US).
- Known human immunodeficiency virus (HIV) infection or HIV-related disease.
- Hepatitis C virus infection.
- Genetic immunodeficiency.
- Abnormalities of splenic or thymic function.
- Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Participants with history of current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a prolonged period of habitation (≥1 year) in a dengue endemic area during trial conduct.
Data sourced from ClinicalTrials.gov (NCT03999996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.