A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults and Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 341
- 主要终点
- Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE)
研究概览
简要总结
This study is designed to assess the safety, tolerability, and immunogenicity of 5 different formulations of V114 in healthy adults and infants. Adults only will be enrolled in Period 1 and infants only will be enrolled in Period 2; Period 1 will complete prior to the start of Period 2.
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 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy and able to attend all scheduled visits.
- •Highly unlikely to conceive from vaccination to 6 weeks after administration of the vaccine.
排除标准
- •Infants and Adults:
- •Prior administration of any pneumococcal vaccine, any non-live vaccine within 14 days, or any live vaccine within 30 days.
- •History of invasive pneumococcal disease.
- •Known hypersensitivity to any vaccine component.
- •Received systemic corticosteroids within 14 days of first vaccination.
- •Known or suspected impairment of immune function.
- •Febrile illness within 72 hours before vaccination.
- •Received blood transfusion or blood products within 30 days. Infants
- •Mother has documented human immunodeficiency virus or is hepatitis B surface antigen positive.
- •Has asplenia or failure to thrive.
- •Is breastfeeding.
研究组 & 干预措施
Adult V114: 1x:1x:1x
Adults receive a single vaccination on Day 1.
干预措施: V114 1x:1x:1x (Biological)
Adult V114: 2x:2x:2x
Adults receive a single vaccination on Day 1.
干预措施: V114 2x:2x:2x (Biological)
Infant V114: 1x:1x:1x
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
干预措施: V114 1x:1x:1x (Biological)
Infant V114: 2x:1x:2x
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
干预措施: V114 2x:1x:2x (Biological)
Infant V114: 2x:2x:2x
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
干预措施: V114 2x:2x:2x (Biological)
Infant V114: 0.5x:0.5x:2x
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
干预措施: V114 0.5x:0.5x:2x (Biological)
Infant V114: 1x:1x:2x
Infants receive 4 total vaccinations given at 2, 4, 6, and 12 to 15 months of age.
干预措施: V114 1x:1x:2x (Biological)
Infant Prevnar 13®
Infants receive 4 total vaccinations given 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 Adult Participants Experiencing ≥1 Adverse Event (AE)
时间窗: Up to 14 days
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
时间窗: Up to 14 days
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®
时间窗: Month 7 (1 month PD3)
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®
时间窗: Month 7 (1 month PD3)
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®
时间窗: Month 7 (1 month PD3)
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®
时间窗: Month 7 (1 month PD3)
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®
时间窗: Month 7 (1 month PD3)
The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.
Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE)
时间窗: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.
Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)
时间窗: Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.
Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)
时间窗: Month 7 (1 month PD3)
A mulitvariate regression model was used to evaluate the impact of increasing polysaccharide concentration from 1x to 2x on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase from 1x to 2x in polysaccharide concentration. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values \>1.0 show an increase in antibody concentration whereas values \<1.0 show a decrease in antibody concentration.
Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants
时间窗: Month 7 (1 month PD3)
A mulitvariate regression model was used to evaluate the impact of increasing APA concentration on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase in APA. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values \>1.0 show an increase in antibody concentration whereas values \<1.0 show a decrease in antibody concentration.
次要结局
- Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®(One month following the 4th vaccination (approximately 13 to 16 months of age).)
- Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®(One month following the 4th vaccination (approximately 13 to 16 months of age).)
- Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)(Month 7 (1 month PD3))
- Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)(Month 7 (1 month PD3))
- Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®(One month following the 4th vaccination (approximately 13 to 16 months of age).)
- Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®(One month following the 4th vaccination (approximately 13 to 16 months of age).)
- Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®(One month following the 4th vaccination (approximately 13 to 16 months of age).)
- Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants(One month following the 4th vaccination (approximately 13 to 16 months of age))
- Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults(Month 2 (1 month after a single vaccination))
- Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults(Month 2 (1 month after a single vaccination))