A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 338
- 主要终点
- Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
研究概览
简要总结
This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.
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
- 2 Months 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult Cohort: 18 to 49 years and in good health
- •Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.
- •Infant Cohort: approximately 2 months (42 to 90 days) and in good health.
排除标准
- •Adult cohort: Prior administration of any pneumococcal vaccine
- •History of invasive pneumococcal disease
- •Known hypersensitivity to any vaccine component
- •Known or suspected impairment of immune function
- •Coagulation disorder contraindicating intramuscular vaccination
- •Received a blood transfusion or blood products within 6 months
- •Participated in another clinical study of an investigational product within 2 months
- •Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine
- •Known hypersensitivity to any vaccine component
- •Known or suspected impairment of immune function
- •History of congenital or acquired immunodeficiency
- •Has or mother has documented Human Immunodeficiency virus (HIV) infection
- •Has or mother has documented hepatitis B surface antigen positive result
- •Functional or anatomic asplenia
- •History of failure to thrive
- •Coagulation disorder contraindicating intramuscular vaccination
- •History of autoimmune disease or autoimmune disorder
- •Known neurologic or cognitive behavioral disorder
- •Received systemic corticosteroids within 14 days
- •Received other licensed non-live vaccine within 14 days
- •Received other licensed live virus vaccine within 30 days
- •Received a blood transfusion or blood products
- •Participated in another clinical study of an investigational product
- •History of invasive pneumococcal disease
研究组 & 干预措施
Adult: V114 Medium Dose
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.
干预措施: V114 Medium Dose (Biological)
Adult: V114 High Dose
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.
干预措施: V114 High Dose (Biological)
Adult: V114 Medium Dose with Alternative Carrier Protein
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1.
干预措施: V114 Medium Dose with Alternative Carrier Protein (Biological)
Adult: V114 High Dose with Alternative Carrier Protein
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1.
干预措施: V114 High Dose with Alternative Carrier Protein (Biological)
Infant: V114 Medium Dose
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12 to 15 months of age.
干预措施: V114 Medium Dose (Biological)
Infant: V114 High Dose
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12 to 15 months of age.
干预措施: V114 High Dose (Biological)
Infant: V114 Medium Dose with Alternative Carrier Protein
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
干预措施: V114 Medium Dose with Alternative Carrier Protein (Biological)
Infant: V114 High Dose with Alternative Carrier Protein
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
干预措施: V114 High Dose with Alternative Carrier Protein (Biological)
Infant: Prevnar 13™
Infant participants will receive a 0.5 mL intramuscular injection 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
Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
时间窗: Up to 14 days after any vaccination
Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.
Adults: Percentage of Participants With an Adverse Event
时间窗: Up to 6 weeks after vaccination
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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.
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
时间窗: 1 month after Vaccination 3 (Month 5)
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Infants: Percentage of Participants With a Solicited Systemic Adverse Event
时间窗: Up to 14 days after any vaccination
Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
Infants: Percentage of Participants With an Adverse Event
时间窗: Up to 1 month after Vaccination 4 (Month 11-15)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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.
Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
时间窗: Up to time of Vaccination 4 (Month 10-13)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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.
次要结局
- Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3(1 month after Vaccination 3 (Month 5))
- Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4(Before Vaccination 4 (Month 10-13))
- Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies(1 month after Vaccination 4 (Month 11-15))
- Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies(1 month after vaccination)
- Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4(1 month after Vaccination 4 (Month 11-15))
- Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies(Baseline and 1 month after vaccination)
- Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies(Before Vaccination 4 (Month 10-13))