Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
第3相
完了
NCT03999996
| 対象疾患 | Dengue Fever |
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| 相 | 第3相 |
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| スポンサー | Takeda |
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| ステータス | 完了 |
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| 参加者数 | 365 名 |
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| 介入（薬剤） | Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) |
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| 開始日 | 2019年11月12日 |
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| 完了日 | 2024年5月25日 |
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| 結果公開日 | 2025年6月12日 |
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概要
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.
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) · titer
| Prior to Booster: DEN-304 | 76.8 titer |
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| Prior to Booster: DEN-315 | 88.6 titer |
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| Prior to Booster: DEN-304 | 539.6 titer |
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| Prior to Booster: DEN-315 | 425.6 titer |
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| Prior to Booster: DEN-304 | 33.7 titer |
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| Prior to Booster: DEN-315 | 29.5 titer |
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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 · titer
| Prior to Booster: DEN-304 | 58.4 titer |
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| Prior to Booster: DEN-315 | 96.4 titer |
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| Prior to Booster: DEN-304 | 427.3 titer |
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| Prior to Booster: DEN-315 | 276.1 titer |
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| Prior to Booster: DEN-304 | 32.8 titer |
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| Prior to Booster: DEN-315 | 25.3 titer |
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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) · titer
| Prior to Booster: DEN-304 | 121.7 titer |
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| Prior to Booster: DEN-304 | 560.2 titer |
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| Prior to Booster: DEN-304 | 40.3 titer |
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| Prior to Booster: DEN-304 | 37.6 titer |
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