A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,080
- 试验地点
- 56
- 主要终点
- Number of Participants With Solicited Injection-site Adverse Events (AEs)
研究概览
简要总结
This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent
排除标准
- •Has a history of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years
- •Has a known hypersensitivity to any component of V116 or any influenza vaccine, including diphtheria toxoid
- •Has a 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
- •Has a coagulation disorder contraindicating intramuscular vaccination
- •Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
- •Is expected to receive any pneumococcal vaccine during the study outside of the protocol
- •Received any pneumococcal vaccine <12 months prior to enrollment (including pneumococcal 13-valent conjugate vaccine [PCV13] followed by pneumococcal 23-valent polysaccharide vaccine [PPSV23] and PPSV23 followed by PCV13)
- •Had prior administration of PCV15 or PCV20
- •Received any influenza vaccine <6 months prior to enrollment or is expected to receive any influenza vaccine during the study outside of the protocol
- •Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
- •Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
- •Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine
- •Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
- •Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product before the Day 30 postvaccination blood draw is complete
- •Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study
研究组 & 干预措施
Concomitant group (V116 + QIV followed by placebo)
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30
干预措施: V116 (Biological)
Concomitant group (V116 + QIV followed by placebo)
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30
干预措施: QIV (Biological)
Concomitant group (V116 + QIV followed by placebo)
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30
干预措施: Matching Placebo for V116 (Biological)
Sequential group (placebo + QIV followed by V116)
Participants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30
干预措施: V116 (Biological)
Sequential group (placebo + QIV followed by V116)
Participants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30
干预措施: QIV (Biological)
Sequential group (placebo + QIV followed by V116)
Participants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30
干预措施: Matching Placebo for V116 (Biological)
结局指标
主要结局
Number of Participants With Solicited Injection-site Adverse Events (AEs)
时间窗: Up to 5 days post-vaccination
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling.
Number of Participants With Solicited Systemic AEs
时间窗: Up to 5 days post-vaccination
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include fatigue, headache, myalgia, and pyrexia.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
时间窗: Up to ~6 months postvaccination with V116
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses
时间窗: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)
OPA for the serotypes in V116 were determined using a multiplexed opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs (GMTs) (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated.
GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)
时间窗: Day 30
GMTs for the 4 strains contained in QIV vaccine were determined using an HAI assay.
次要结局
- GMFR Ratio of Serotype-specific IgG(Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group))
- Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)(30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group))
- Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA(Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group))
- GMFR in Influenza Strain-specific HAI(Day 1 (Baseline) and Day 30 (Postvaccination))
- Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40(Day 30)