a Sanofi Pasteur , Swiftwater , PA , USA.
b Department of Pediatrics , University of Pittsburgh School of Medicine , Pittsburgh , PA , USA.
Hum Vaccin Immunother. 2017 Sep 2;13(9):2058-2064. doi: 10.1080/21645515.2017.1344375.
Frequent mismatches between the predominant circulating B strain lineage and the B strain lineage in trivalent influenza vaccines have resulted in missed opportunities to prevent influenza illness. Quadrivalent influenza vaccines containing B strains from each of the 2 lineages have been developed for improved prevention of influenza B infections. Here, we describe the results of a phase III, randomized, double-blind, active-controlled, multicenter trial examining the safety and immunogenicity of a split-virion inactivated quadrivalent influenza vaccine (IIV4) in 675 adults ≥ 65 y of age (NCT01218646). Participants were randomly assigned 1:1:1 to receive a single intramuscular injection with the investigational IIV4, or one of 2 split-virion trivalent inactivated influenza vaccines (IIV3s): a licensed IIV3 containing a B Victoria-lineage strain or an investigational IIV3 containing a B Yamagata-lineage strain. Post-vaccination (day 21) hemagglutinin inhibition titers to all strains induced by IIV4 were statistically non-inferior to those induced by the 2 IIV3s. In addition, for each B strain, rates of seroconversion in the IIV4 group were superior to those induced by the comparator IIV3 not containing that B strain. For all vaccines, the most common solicited reaction was injection-site pain, and most reactions were mild to moderate in intensity and transient. Overall safety profiles were similar between IIV4 and the IIV3s, and no vaccine-related serious adverse events were reported. These results confirm that in adults ≥ 65 y of age, IIV4 was well tolerated and immunogenic against the additional B lineage strain without compromising the immunogenicity of the other 3 vaccine strains.
三价流感疫苗中流行的 B 株系与疫苗中包含的 B 株系经常不匹配，导致错失了预防流感疾病的机会。为了更好地预防乙型流感感染，已经开发出了包含两种谱系 B 株的四价流感疫苗。在此，我们描述了一项 III 期、随机、双盲、活性对照、多中心试验的结果，该试验评估了 675 名年龄≥65 岁的成年人中使用单价全病毒灭活四价流感疫苗（IIV4）的安全性和免疫原性（NCT01218646）。参与者以 1:1:1 的比例随机分配，接受单次肌内注射研究性 IIV4，或接受 2 种单价全病毒三价灭活流感疫苗（IIV3）中的 1 种：含 B 维多利亚谱系株的已上市 IIV3 或含 B 山形谱系株的研究性 IIV3。接种后（第 21 天），IIV4 诱导的针对所有毒株的血凝素抑制滴度与 2 种 IIV3 诱导的滴度均具有统计学非劣效性。此外，对于每种 B 株，IIV4 组的血清转化率均优于不包含该 B 株的对照 IIV3 诱导的血清转化率。对于所有疫苗，最常见的局部反应是注射部位疼痛，大多数反应的强度和持续时间为轻度至中度。IIV4 与 IIV3 的总体安全性特征相似，未报告与疫苗相关的严重不良事件。这些结果证实，在年龄≥65 岁的成年人中，IIV4 耐受性良好且针对额外的 B 谱系株具有免疫原性，而不会影响其他 3 种疫苗株的免疫原性。
