A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 68
- 主要终点
- Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
研究概览
简要总结
The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.
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
- •Is Healthy, based on clinical judgment of the investigator
- •Has 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
- •Has a 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
- •Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine
- •Has any contraindication to the concomitant study vaccines being administered in the study
- •Has a known or suspected impairment of immunological function
- •Has a history of congenital or acquired immunodeficiency
- •Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
- •Has or his/her mother has a documented hepatitis B surface antigen - positive test
- •Has known or history of functional or anatomic asplenia
- •Has failure to thrive based on the clinical judgment of the investigator
- •Has a known coagulation disorder contraindicating intramuscular vaccination
- •Has a 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)
- •Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
- •Has received a dose of any pneumococcal vaccine prior to study entry
- •Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
- •Has received a dose of rotavirus vaccine prior to study entry
- •Has received a blood transfusion or blood products, including immunoglobulins
- •Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study
- •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 (e.g., parent/legal guardian or sibling) 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 Vaccine-related Serious Adverse Event (SAE)
时间窗: Up to ~6 months after Vaccination 4 (up to ~19 months)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgement. Relatedness of an SAE to the study vaccine was determined by the investigator. Per protocol, the percentage of participants with vaccine-related SAEs was assessed through 6 months following Vaccination 4.
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
时间窗: 30 Days after Vaccination 4 (Months 11-14)
The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a pneumococcal electrochemiluminescence (PnECL) assay. Per protocol, 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified primary outcome analysis; 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified secondary outcome analysis and reported later in the record.
Percentage of Participants With a Solicited Systemic AE
时间窗: Up to ~14 days after each 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. Per protocol, the percentage of participants with solicited systemic AEs was assessed for up to \~14 days after each vaccination. The solicited systemic AEs assessed were appetite lost/decreased appetite, irritability, drowsiness/somnolence and hives or welts/urticaria.
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
时间窗: Up to ~14 days after each 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. Per protocol, the percentage of participants with solicited injection-site AEs was assessed for up to \~14 days after each vaccination. The solicited injection-site AEs assessed were erythema/redness, induration/hard lump, tenderness/pain and swelling.
次要结局
- Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4(30 Days after Vaccination 4 (Months 11-14))
- Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3(30 Days after Vaccination 3 (Month 5))
- Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3(30 Days after Vaccination 3 (Month 5))
- Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3(30 Days after Vaccination 3 (Month 5))
- GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3(30 Days after Vaccination 3 (Month 5))