PDF(Pubmed)
Abstract：
UNASSIGNED: Considering that vaccination with the sIPV and DTaP overlap at the ages of 3 and 4 months in China, to reduce the burden of treatment on parents and increase vaccination coverage rates, we designed a postmarket clinical study of co-administration.
UNASSIGNED: The Sabin-strain-based inactivated poliovirus vaccine (sIPV) and the diphtheria-tetanus-acellular pertussis vaccine (DTaP) have been licensed in China for many years. To conduct a clinical study on the safety and immunogenicity of the sIPV when administered concomitantly with the DTaP.
UNASSIGNED: The study population was divided into three groups: group 1 was the sIPV+ DTaP concomitant administration group, group 2 was the sIPV inoculation group, and group 3 was the DTaP inoculation group. Blood samples were collected prevaccination and 30 days postvaccination, and serum antibody levels were detected.
UNASSIGNED: This study showed that the seropositive and seroconversion rates of type 1, 2 and 3 poliovirus in group 1 were higher than those in group 2, with no statistically significant difference after vaccination (P>0.05). Groups 1 and 3 also showed similar responses for all vaccine antigens except anti-FHA (97.65 (94.09-99.36) vs. 100 (97.89-100)). The geometric mean titers (GMTs) for the DTaP and sIPV among the groups were comparable, and the non-inferiority t test result was P<0.001. The number of local adverse events (AEs) reported in group 1 (29.91%) were larger than those in group 2 (12.39%) and group 3 (21.93%), among which the most common was redness. Similarly, the most common systemic AE was fever. All 5 severe AE (SAE) cases were determined by experts to be unrelated to the vaccines during the study.
UNASSIGNED: The evidence of similar seroconversion and safety with co-administered DTaP and sIPV supports the co-administration supports the introduction of a strategy of simultaneous administration of both vaccines into routine infant immunization, and it could increase vaccination coverage and protect more infants from morbidity and mortality from these related diseases.
UNASSIGNED: https://clinicaltrials.gov/ct2/show/NCT04054882?term=NCT04054882&cntry=CN&draw=2&rank=1, identifier NCT04054882.
UNASSIGNED: The Sabin-strain-based inactivated poliovirus vaccine (sIPV) and the diphtheria-tetanus-acellular pertussis vaccine (DTaP) have been licensed in China for many years. To conduct a clinical study on the safety and immunogenicity of the sIPV when administered concomitantly with the DTaP.
UNASSIGNED: The study population was divided into three groups: group 1 was the sIPV+ DTaP concomitant administration group, group 2 was the sIPV inoculation group, and group 3 was the DTaP inoculation group. Blood samples were collected prevaccination and 30 days postvaccination, and serum antibody levels were detected.
UNASSIGNED: This study showed that the seropositive and seroconversion rates of type 1, 2 and 3 poliovirus in group 1 were higher than those in group 2, with no statistically significant difference after vaccination (P>0.05). Groups 1 and 3 also showed similar responses for all vaccine antigens except anti-FHA (97.65 (94.09-99.36) vs. 100 (97.89-100)). The geometric mean titers (GMTs) for the DTaP and sIPV among the groups were comparable, and the non-inferiority t test result was P<0.001. The number of local adverse events (AEs) reported in group 1 (29.91%) were larger than those in group 2 (12.39%) and group 3 (21.93%), among which the most common was redness. Similarly, the most common systemic AE was fever. All 5 severe AE (SAE) cases were determined by experts to be unrelated to the vaccines during the study.
UNASSIGNED: The evidence of similar seroconversion and safety with co-administered DTaP and sIPV supports the co-administration supports the introduction of a strategy of simultaneous administration of both vaccines into routine infant immunization, and it could increase vaccination coverage and protect more infants from morbidity and mortality from these related diseases.
UNASSIGNED: https://clinicaltrials.gov/ct2/show/NCT04054882?term=NCT04054882&cntry=CN&draw=2&rank=1, identifier NCT04054882.
摘要：
考虑到在中国接种sIPV和DTaP疫苗在3个月和4个月的年龄重叠，减轻父母的治疗负担，提高疫苗接种率，我们设计了一项联合用药的上市后临床研究。
基于萨宾毒株的灭活脊髓灰质炎病毒疫苗（sIPV）和白喉-破伤风-无细胞百日咳疫苗（DTaP）已在中国获得许可多年。对与DTaP同时施用时sIPV的安全性和免疫原性进行临床研究。
研究人群分为三组：第1组是sIPV+DTaP伴随给药组，第2组为SIPV接种组，第3组为DTaP接种组。在接种前和接种后30天收集血样，检测血清抗体水平。
本研究显示，1组1、2、3型脊髓灰质炎病毒的血清阳性率和血清转换率均高于2组，接种后差异无统计学意义（P>0.05）。第1组和第3组除了抗FHA外，对所有疫苗抗原也显示出相似的反应（97.65（94.09-99.36）与100（97.89-100））。各组间DTaP和sIPV的几何平均滴度(GMT)具有可比性,非劣效性t检验结果为P<0.001。第1组报告的局部不良事件（AEs）数量（29.91%）高于第2组（12.39%）和第3组（21.93%）。其中最常见的是发红。同样，最常见的全身性AE是发热.专家确定所有5例严重AE(SAE)病例与研究期间的疫苗无关。
DTaP和sIPV共同给药的血清转化和安全性相似的证据支持共同给药支持在常规婴儿免疫中引入同时给药两种疫苗的策略。它可以增加疫苗接种覆盖率，保护更多的婴儿免受这些相关疾病的发病率和死亡率。
https://clinicaltrials.gov/ct2/show/NCT04054882?term=NCT04054882&cntry=CN&draw=2&rank=1，标识符NCT04054882。
基于萨宾毒株的灭活脊髓灰质炎病毒疫苗（sIPV）和白喉-破伤风-无细胞百日咳疫苗（DTaP）已在中国获得许可多年。对与DTaP同时施用时sIPV的安全性和免疫原性进行临床研究。
研究人群分为三组：第1组是sIPV+DTaP伴随给药组，第2组为SIPV接种组，第3组为DTaP接种组。在接种前和接种后30天收集血样，检测血清抗体水平。
本研究显示，1组1、2、3型脊髓灰质炎病毒的血清阳性率和血清转换率均高于2组，接种后差异无统计学意义（P>0.05）。第1组和第3组除了抗FHA外，对所有疫苗抗原也显示出相似的反应（97.65（94.09-99.36）与100（97.89-100））。各组间DTaP和sIPV的几何平均滴度(GMT)具有可比性,非劣效性t检验结果为P<0.001。第1组报告的局部不良事件（AEs）数量（29.91%）高于第2组（12.39%）和第3组（21.93%）。其中最常见的是发红。同样，最常见的全身性AE是发热.专家确定所有5例严重AE(SAE)病例与研究期间的疫苗无关。
DTaP和sIPV共同给药的血清转化和安全性相似的证据支持共同给药支持在常规婴儿免疫中引入同时给药两种疫苗的策略。它可以增加疫苗接种覆盖率，保护更多的婴儿免受这些相关疾病的发病率和死亡率。
https://clinicaltrials.gov/ct2/show/NCT04054882?term=NCT04054882&cntry=CN&draw=2&rank=1，标识符NCT04054882。
