Abstract：
V114 (15-valent pneumococcal conjugate vaccine [PCV]) contains all serotypes in 13-valent PCV (PCV13) and additional serotypes 22F and 33F. This study evaluated safety and immunogenicity of V114 compared with PCV13 in healthy infants, and concomitant administration with DTPa-HBV-IPV/Hib and rotavirus RV1 vaccines.
V114 and PCV13 were administered in a 2+1 schedule at 2, 4, and 11-15 months of age. Adverse events (AEs) were collected on Days 1-14 following each vaccination. Serotype-specific anti-pneumococcal immunoglobulin G (IgG) was measured 30 days post-primary series (PPS), immediately prior to a toddler dose, and 30 days post-toddler dose (PTD). Primary objectives included non-inferiority of V114 to PCV13 for 13 shared serotypes and superiority of V114 to PCV13 for the two additional serotypes.
1184 healthy infants 42-90 days of age were randomized 1:1 to V114 (n = 591) or PCV13 (n = 593). Proportions of participants with solicited AEs and serious AEs were comparable between vaccination groups. V114 met pre-specified non-inferiority criteria for all 13 shared serotypes, based on the difference in proportions of participants with serotype-specific IgG concentrations ≥0.35 μg/mL (response rate; lower bound of two-sided 95% confidence interval [CI] >-10.0) and IgG geometric mean concentration (GMC) ratios (lower bound of two-sided 95% CI >0.5), and pre-specified superiority criteria for serotypes 22F and 33F (lower bound of two-sided 95% CI >10.0 for response rates and >2.0 for GMC ratios). Antibody responses to DTPa-HBV-IPV/Hib and RV1 vaccines met pre-specified non-inferiority criteria, based on antigen-specific response rates to DTPa-HBV-IPV/Hib and anti-rotavirus IgA geometric mean titers.
After a 2+1 schedule, V114 elicited non-inferior immune responses to 13 shared serotypes and superior responses to the two additional serotypes compared with PCV13, with comparable safety profile. These results support the routine use of V114 in infants.
ClinicalTrials.gov: NCT04031846; EudraCT: 2018-003787-31.
V114 and PCV13 were administered in a 2+1 schedule at 2, 4, and 11-15 months of age. Adverse events (AEs) were collected on Days 1-14 following each vaccination. Serotype-specific anti-pneumococcal immunoglobulin G (IgG) was measured 30 days post-primary series (PPS), immediately prior to a toddler dose, and 30 days post-toddler dose (PTD). Primary objectives included non-inferiority of V114 to PCV13 for 13 shared serotypes and superiority of V114 to PCV13 for the two additional serotypes.
1184 healthy infants 42-90 days of age were randomized 1:1 to V114 (n = 591) or PCV13 (n = 593). Proportions of participants with solicited AEs and serious AEs were comparable between vaccination groups. V114 met pre-specified non-inferiority criteria for all 13 shared serotypes, based on the difference in proportions of participants with serotype-specific IgG concentrations ≥0.35 μg/mL (response rate; lower bound of two-sided 95% confidence interval [CI] >-10.0) and IgG geometric mean concentration (GMC) ratios (lower bound of two-sided 95% CI >0.5), and pre-specified superiority criteria for serotypes 22F and 33F (lower bound of two-sided 95% CI >10.0 for response rates and >2.0 for GMC ratios). Antibody responses to DTPa-HBV-IPV/Hib and RV1 vaccines met pre-specified non-inferiority criteria, based on antigen-specific response rates to DTPa-HBV-IPV/Hib and anti-rotavirus IgA geometric mean titers.
After a 2+1 schedule, V114 elicited non-inferior immune responses to 13 shared serotypes and superior responses to the two additional serotypes compared with PCV13, with comparable safety profile. These results support the routine use of V114 in infants.
ClinicalTrials.gov: NCT04031846; EudraCT: 2018-003787-31.
摘要：
背景：V114（15价肺炎球菌结合疫苗[PCV]）含有13价PCV（PCV13）中的所有血清型以及其他血清型22F和33F。这项研究评估了V114与PCV13在健康婴儿中的安全性和免疫原性。并同时使用DTPa-HBV-IPV/Hib和轮状病毒RV1疫苗。
方法：V114和PCV13在2、4和11-15月龄以2+1方案给药。在每次接种后第1-14天收集不良事件(AE)。血清型特异性抗肺炎球菌免疫球蛋白G（IgG）在初级系列（PPS）后30天进行测量，在幼儿剂量之前，和幼儿剂量（PTD）后30天。主要目标包括13种共享血清型的V114对PCV13的非劣效性和另外两种血清型的V114对PCV13的优越性。
结果：1184名42-90日龄的健康婴儿以1：1的比例随机分配至V114（n=591）或PCV13（n=593）。在疫苗接种组之间，征求AE和严重AE的参与者比例相当。V114符合所有13种共有血清型的预先指定的非劣效性标准，基于血清型特异性IgG浓度≥0.35μg/mL（反应率；双侧95％置信区间下限[CI]>-10.0）和IgG几何平均浓度（GMC）比率（双侧95％CI下限>0.5）的参与者比例的差异，和预先指定的血清型22F和33F的优势标准(对于应答率而言,双侧95%CI的下限>10.0,对于GMC比率而言>2.0)。DTPa-HBV-IPV/Hib和RV1疫苗的抗体反应符合预先指定的非劣效性标准，基于对DTPa-HBV-IPV/Hib和抗轮状病毒IgA几何平均滴度的抗原特异性应答率。
结论：在2+1时间表之后，与PCV13相比,V114引发对13种共有血清型的非劣质免疫应答和对另外两种血清型的优异应答,具有相当的安全性。这些结果支持V114在婴儿中的常规使用。
背景：ClinicalTrials.gov：NCT04031846；EudraCT：2018-003787-31。
方法：V114和PCV13在2、4和11-15月龄以2+1方案给药。在每次接种后第1-14天收集不良事件(AE)。血清型特异性抗肺炎球菌免疫球蛋白G（IgG）在初级系列（PPS）后30天进行测量，在幼儿剂量之前，和幼儿剂量（PTD）后30天。主要目标包括13种共享血清型的V114对PCV13的非劣效性和另外两种血清型的V114对PCV13的优越性。
结果：1184名42-90日龄的健康婴儿以1：1的比例随机分配至V114（n=591）或PCV13（n=593）。在疫苗接种组之间，征求AE和严重AE的参与者比例相当。V114符合所有13种共有血清型的预先指定的非劣效性标准，基于血清型特异性IgG浓度≥0.35μg/mL（反应率；双侧95％置信区间下限[CI]>-10.0）和IgG几何平均浓度（GMC）比率（双侧95％CI下限>0.5）的参与者比例的差异，和预先指定的血清型22F和33F的优势标准(对于应答率而言,双侧95%CI的下限>10.0,对于GMC比率而言>2.0)。DTPa-HBV-IPV/Hib和RV1疫苗的抗体反应符合预先指定的非劣效性标准，基于对DTPa-HBV-IPV/Hib和抗轮状病毒IgA几何平均滴度的抗原特异性应答率。
结论：在2+1时间表之后，与PCV13相比,V114引发对13种共有血清型的非劣质免疫应答和对另外两种血清型的优异应答,具有相当的安全性。这些结果支持V114在婴儿中的常规使用。
背景：ClinicalTrials.gov：NCT04031846；EudraCT：2018-003787-31。
