PDF(Pubmed)
Abstract：
This open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three doses of an intramuscular, inactivated poliomyelitis vaccine (IPV) in 400 healthy infants. The primary objective was the non-inferiority of neutralizing antibody (nAb) responses in the concomitant- versus the staggered-use groups. Antibody responses were measured at baseline and 1-month post-dose 3 (PD3). Parents/legal guardians recorded adverse events for 30 or 15 d after study vaccinations in the concomitant-use or staggered-use groups, respectively. At PD3, >98% of participants seroconverted to all three poliovirus types, and the primary objective was met as lower bounds of the two-sided 95% CI for between-group difference in nAb seroconversion percentages ranged from - 4.3% to - 1.6%, for all poliovirus types, p < .001. At PD3, geometric mean titers (GMTs) of nAb responses to poliovirus types 1, 2, and 3 in the concomitant-use group and the staggered-use group were comparable; 100% of participants had nAb titers ≥1:8 and ≥1:64 for all poliovirus types. Anti-rotavirus serotype-specific IgA GMTs and participants with ≥3-fold rise in postvaccination titers from baseline were comparable between groups. Administration of RV5 and IPV was well tolerated with comparable safety profiles in both groups. The immunogenicity of IPV in the concomitant-use group was non-inferior to the staggered-use group and RV5 was immunogenic in both groups. No safety concerns were identified. These data support the concomitant use of RV5 and IPV in healthy Chinese infants.
摘要：
这个开放标签，随机化，中国的3期研究（V260-074;NCT04481191）评估了同时和交错给药三种剂量口服的免疫原性和安全性，活,五价轮状病毒疫苗（RV5）和三个剂量的肌肉，400名健康婴儿的脊髓灰质炎灭活疫苗（IPV）。主要目标是伴随与交错使用组中的中和抗体（nAb）反应的非劣效性。在基线和剂量3(PD3)后1个月测量抗体应答。在伴随使用或交错使用组的研究疫苗接种后，父母/法定监护人记录了30或15天的不良事件。分别。在PD3时，>98％的参与者血清转化为所有三种脊髓灰质炎病毒类型，并且主要目标得到满足，因为nAb血清转换百分比组间差异的双侧95％CI的下限范围为-4.3％至-1.6％，对于所有类型的脊髓灰质炎病毒，p<.001。在PD3时，伴随使用组和交错使用组中对1、2和3型脊髓灰质炎病毒的nAb反应的几何平均滴度（GMT）具有可比性；对于所有脊髓灰质炎病毒类型，100％的参与者的nAb滴度≥1：8和≥1：64。抗轮状病毒血清型特异性IgAGMT和疫苗接种后滴度比基线升高≥3倍的参与者在组间具有可比性。两组患者对RV5和IPV的给药耐受性良好，安全性相当。伴随使用组IPV的免疫原性不劣于交错使用组，两组RV5均具有免疫原性。没有发现安全问题。这些数据支持在健康的中国婴儿中同时使用RV5和IPV。
