A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,409
- 试验地点
- 152
- 主要终点
- Percentage of Participants With a Solicited Injection-site Adverse Event
研究概览
简要总结
This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 42 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator
- •Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent
- •Have a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
排除标准
- •History of Invasive Pneumococcal Disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease
- •Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine
- •Known or suspected impairment of immunological function
- •History of congenital or acquired immunodeficiency
- •Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
- •Known or history of functional or anatomic asplenia
- •Failure to thrive based on the clinical judgment of the investigator
- •Known coagulation disorder contraindicating intramuscular vaccination
- •History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)
- •Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
- •Received a dose of any pneumococcal vaccine prior to study entry
- •Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine
- •Participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included.
- •Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
- •Has an immediate family member who is investigational site or Sponsor staff directly involved with this study.
结局指标
主要结局
Percentage of Participants With a Solicited Injection-site Adverse Event
时间窗: Up to Day 14 after each study vaccination
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Percentage of Participants With a Vaccine-related Serious Adverse Event
时间窗: Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)
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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Percentage of Participants With a Solicited Systemic Adverse Event
时间窗: Up to Day 14 after each study vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).
次要结局
- Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)(30 days after Vaccination 3 (approximately 5 months after Vaccination 1))
- GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)(Before Vaccination 4 (10-13 months after Vaccination 1))
- GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)(30 days after Vaccination 4 (11-14 months after Vaccination 1))
- Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only)(30 days after Vaccination 3 (approximately 5 months after Vaccination 1))