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高齢者における帯状疱疹ワクチンの長期有効性、安全性、および免疫応答の持続性に関する研究
基本情報
- NCT ID
- NCT05371080
- ステータス
- 実施中(募集終了)
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 3,038
- 治験依頼者名
- GlaxoSmithKline
概要
The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults. The persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of HZ/su vaccine administered to a small group of participants in ZOSTER-049 study (approximately 5 years after the initial vaccination in ZOSTER-006/022 studies) will also be assessed.
対象疾患
Herpes Zoster
介入
HZ/su vaccine(BIOLOGICAL)
依頼者(Sponsor)
グラクソ・スミスクライン株式会社(INDUSTRY)