2023-506236-32-00已完成3 期
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease.
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 21
- 主要终点
- Percentage of participants with solicited injection-site adverse events (AEs)
研究概览
简要总结
- To evaluate the safety and tolerability of V116 with respect to the proportion of participants with adverse events (AEs)
- To compare the serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs) at 30 days postvaccination with V116 versus PPSV23.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Has one or more of the following risk conditions for pneumococcal disease: • Diabetes mellitus receiving treatment with antidiabetic medication • Chronic compensated liver disease • Chronic lung disease • Chronic heart disease • Chronic kidney disease, with chronic kidney insufficiency/impairment
- •Receiving stable medical management for the risk conditions listed above for ≥3 months.
- •Has not received pneumococcal vaccine, polyvalent (23-valent) (PPSV23) or has received not more than 1 dose of PPSV23 ≥5 years before study vaccination.
排除标准
- •Had a curative procedure/surgery for chronic heart disease and does not require medication, follow-up, additional interventions, or further management per local guidelines.
- •History of active hepatitis within 3 months before study vaccination
- •History of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before study vaccination
- •History of severely decreased kidney function
- •History of severe pulmonary hypertension
- •History of invasive pneumococcal disease (IPD) or known history of other culture-positive pneumococcal disease within 3 years before study vaccination
结局指标
主要结局
Percentage of participants with solicited injection-site adverse events (AEs)
Percentage of participants with solicited injection-site adverse events (AEs)
Percentage of participants with solicited systemic AEs
Percentage of participants with solicited systemic AEs
Percentage of participants with vaccine-related serious adverse events (SAEs)
Percentage of participants with vaccine-related serious adverse events (SAEs)
Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) following vaccination
Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) following vaccination
次要结局
- Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) after vaccination
- Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs
- Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs GMTs
- GMFR from baseline in serotype-specific IgG GMCs
- Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs
研究者
Jayani Pathirana
Scientific
Merck Sharp & Dohme LLC
研究点 (21)
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