A Phase 1/Phase 2, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Adults.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 20
- 主要终点
- Phase 1: Percentage of Participants With a Solicited Systemic AE
研究概览
简要总结
This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of V116 when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: V116 is noninferior to Pneumovax™23 as measured by the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for the common serotypes at 30 days postvaccination and that the serotype-specific OPA GMTs for the unique serotypes in V116 at 30 days postvaccination are statistically significantly greater following vaccination with V116 than those following vaccination with Pneumovax™23.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, from 18 years to 49 years of age inclusive
- •Male or female ≥50 years of age Phase 1 and Phase 2
- •Males: refrain from donating sperm, remain abstinent during study or agree to use condom
- •Females: Not pregnant. If a woman of childbearing potential, agree to use contraception or remain abstinent
排除标准
- •History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years of screening
- •Known hypersensitivity to any component of the pPCV, or any diphtheria toxoid-containing vaccine
- •Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
- •Coagulation disorder contraindicating IM vaccination
- •Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours of screening
- •Known malignancy that is progressing or has required active treatment within 3 years.(Note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [eg, breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded)
- •Received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study, outside of the protocol.
- •Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
- •Received a blood transfusion or blood products, including immunoglobulin, 6 months before study vaccination or is scheduled to receive a blood transfusion or blood product
研究组 & 干预措施
Phase 1: Pneumovax™23
Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 1
干预措施: Pneumovax™23 (Biological)
Phase 2: Pneumovax™23
Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 2
干预措施: Pneumovax™23 (Biological)
Phase 2: V116
Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 2
干预措施: V116 (Biological)
Phase 1: V116 1.0 mL
Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 1
干预措施: V116 (Biological)
Phase 1: V116 0.5 mL
Participants will receive a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1
干预措施: V116 (Biological)
结局指标
主要结局
Phase 1: Percentage of Participants With a Solicited Systemic AE
时间窗: Up to 5 days post-vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was assessed.
Phase 2: Percentage of Participants With Vaccine-related SAEs
时间窗: Up to Day 293
An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced at least one SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported.
Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116
时间窗: 30 days post vaccination
GMTs for the serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
时间窗: Up to 5 days post-vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.
Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
时间窗: Up to Day 195
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported.
Phase 2: Percentage of Participants With a Solicited Systemic AE
时间窗: Up to 5 days post-vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with 1 or more solicited systemic AE was assessed.
Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23
时间窗: 30 days post vaccination
GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the muliplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated.
Phase 2: Percentage of Participants With a Solicited Injection-site AE
时间窗: Up to 5 days post-vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.
次要结局
- Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23(30 days post vaccination)
- Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23(30 days post vaccination)
- Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23(30 days post vaccination)
- Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA(Baseline (Day 1) and 30 days postvaccination)
- Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG(Baseline (Day 1) and 30 days post vaccination)
- Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116(30 days post vaccination)
- Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23(30 days post vaccination)
- Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG(Baseline (Day 1) and 30 days post vaccination)
- Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116(30 days post vaccination)
- Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA(Baseline (Day 1) and 30 days post vaccination)
- Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination(Baseline (Day 1) and 30 days post vaccination)