A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 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
- 1,051
- 试验地点
- 82
- 主要终点
- Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3
研究概览
简要总结
This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of 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
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant approximately 2 months of age (42 days to 90 days), inclusive
- •In good health
排除标准
- •Prior administration of any pneumococcal vaccine
- •Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
- •Known or suspected impairment of immunological function
- •History of congenital or acquired immunodeficiency (eg, splenomegaly)
- •Mother has documented human immunodeficiency virus (HIV) infection
- •Mother has documented hepatitis B surface antigen-positive test result
- •Known or history of functional or anatomic asplenia
- •History of failure to thrive
- •History of a coagulation disorder
- •History of autoimmune disease
- •Known neurologic or cognitive behavioral disorder
- •Expects to require systemic corticosteroids within 30 days after each vaccination during the trial
- •Prior administration of a blood transfusion or blood products, including immunoglobulin
- •Participated in another clinical trial of an investigational product
- •History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
研究组 & 干预措施
V114 Lot 1
Infants will receive a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
干预措施: V114 Lot 1 (Biological)
V114 Lot 2
Infants will receive a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
干预措施: V114 Lot 2 (Biological)
Prevnar 13™
Infants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
干预措施: Prevnar 13™ (Biological)
结局指标
主要结局
Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3
时间窗: 1 month post vaccination 3 (Month 5)
Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
时间窗: Up to 1 month post Vaccination 4 (up to 14 months)
The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.
Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3
时间窗: 1 month post Vaccination 3 (Month 5)
Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.
Percentage of Participants With a Solicited Injection-site Adverse Event
时间窗: Up to 14 days post any vaccination
Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.
Percentage of Participants With a Solicited Systemic Adverse Event
时间窗: Up to 14 days post any vaccination
Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.
Percentage of Participants Who Experience at Least 1 Adverse Event
时间窗: Up to 1 month post Vaccination 4 (up to 14 months)
An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.
次要结局
- Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4(Before Vaccination 4 (Month 10 to 13))
- Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4(1 month post vaccination 4 (Month 11-14))