A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar 13™ in Healthy Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,152
- 主要终点
- Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3
研究概览
简要总结
This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune responses to the 13 serotypes in common Prevnar 13®
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants ≥ 42 days to ≤ 89 days.
- •Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees to allow the child to participate by giving written informed consent.
- •Afebrile, with a rectal temperature <38.1°C (<100.5°F) or axillary temperature <37.8°C (<100.0°F) on day of vaccination.
- •Participant's parent/legal guardian is able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card).
- •Participant is able to attend all scheduled visits and to comply with the study procedures.
- •Participant's parent/legal guardian has access to a telephone.
排除标准
- •Prior administration of any pneumococcal vaccine.
- •Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
- •Known or suspected impairment of immunological function.
- •Participant has a history of congenital or acquired immunodeficiency (e.g., splenomegaly).
- •Participant or his/her mother has documented human immunodeficiency virus (HIV) infection.
- •Functional or anatomic asplenia.
- •History of autoimmune disease including multiple sclerosis (MS), systemic lupus, polymyositis, inclusion body myositis, dermatomyositis, Hashimoto's thyroiditis, Sjogren's syndrome, rheumatoid arthritis, other autoimmune disorders.
- •Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive developmental disorder, and related disorders.
- •Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Participants on intramuscular, oral, or intravenous corticosteroid treatment should be excluded if they are receiving or expected to receive in the period from 30 days prior to Visit 1 through Visit 6 (30 days post-dose 4) more than 2 mg/kg per day of prednisone (or its equivalent), or more than 20 mg/d if they weigh more than 10 kg and are not otherwise immunocompromised. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease.
- •Participant has received other licensed non-live vaccines within the 14 days before receipt of study vaccine.
- •Participant has received a licensed live virus vaccine within the 30 days prior of receipt of study vaccine.
- •Prior receipt of a blood transfusion or blood products, including immunoglobulins.
- •Investigational drugs or vaccines received within the 2 months before receipt of study vaccine.
- •Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study.
- •History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- •A recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F]) occurring within 72 hours before receipt of study vaccine.
- •History of failure to thrive.
- •Participant has a coagulation disorder contraindicating IM vaccination.
- •Participant and his/her mother have documented hepatitis B surface antigen-positive.
- •Any infant who cannot be adequately followed for safety according to the protocol plan.
- •Participant's parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
- •Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
研究组 & 干预措施
V114 Aluminum-adjuvanted
Four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
干预措施: V114 Aluminum-adjuvanted (Biological)
V114 Non-adjuvanted
Four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
干预措施: V114 Non-adjuvanted (Biological)
Prevnar 13®
Four IM doses at 0.5 mL of Prevnar 13® at 2, 4, 6, and 12 to 15 months of age.
干预措施: Prevnar 13® (Biological)
结局指标
主要结局
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3
时间窗: One month postvaccination 3
Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence \[Pn ECL\] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay \[WHO ELISA\] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3
时间窗: One month postvaccination 3
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
IgG GMCs for Postvaccination 4
时间窗: One month postvaccination 4
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Number of Participants With an Injection-site AE
时间窗: Up to Day 14 postvaccination
Injection-site AEs reported by \> 0% of participants in one or more vaccination groups were assessed.
Number of Participants With a Systemic AE
时间窗: Up to Day 14 postvaccination
Systemic AEs reported by \> 0% of participants in one or more vaccination groups were assessed.
Number of Participants Who Discontinued the Study Due to an AE
时间窗: Up to Day 14 postvaccination
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
Number of Participants With a Serious Adverse Event (SAE)
时间窗: Up to one month after last dose of study vaccine
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.
Number of Participants With an Adverse Event (AE)
时间窗: Up to Day 14 postvaccination
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
次要结局
- Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4(One month postvaccination 4)
- OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3(One month postvaccination 3)
- OPA GMTs as Measured by MOPA4 for Postvaccination 4(One month postvaccination 4)
- Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4(One month postvaccination 4)
- Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3(One month postvaccination 3)
- Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4(One month postvaccination 4)