Vasil'eva R I, Lonskaia N I, Nefedova L A, Iaroshevskaia I Iu, Bichurina M A
Zh Mikrobiol Epidemiol Immunobiol. 1987 Mar(3):38-42.
The safety, reactogenic properties and antigenic potency of inactivated whole-virion influenza vaccines produced in the USSR were studied on 1,117 schoolchildren in limited coded clinico-immunological observations. Inactivated chromatographic influenza vaccine obtained from strain A/Texas/1/77 (H3N2) and a variant of this vaccine, developed specially for children and obtained from strains A/Texas/1/77 and B/Leningrad/76, were used for immunization. Both preparations were introduced intradermally in a single injection in a volume of 0.1-0.2 ml by means of bi-3 jet injector. The content of hemagglutinin in this volume varied from 3.0 to 8.0 micrograms. Clinico-laboratory investigations demonstrated the safety of mono- and bivalent inactivated whole-virion influenza vaccine administered intradermally in a single injection to children of school age. The vaccines showed low reactogenicity and high antigenic potency in children aged 7-10 and 11-14 years, and the optimal doses of the preparations were selected for children of different age groups. The distinct prophylactic effectiveness of inactivated chemical chromatographic influenza vaccines in children aged 11-14 years was revealed 11 months after immunization, the index of immunological effectiveness being 1.7.
在有限的编码临床免疫学观察中，对1117名学童研究了苏联生产的灭活全病毒流感疫苗的安全性、反应原性和抗原效力。从A/德州/1/77（H3N2）毒株获得的灭活层析流感疫苗以及专门为儿童研发的该疫苗变体（从A/德州/1/77和B/列宁格勒/76毒株获得）用于免疫接种。两种制剂均通过双3喷射注射器以0.1 - 0.2毫升的体积皮内单次注射。该体积中的血凝素含量在3.0至8.0微克之间变化。临床实验室研究表明，对学龄儿童皮内单次注射单价和双价灭活全病毒流感疫苗是安全的。这些疫苗在7 - 10岁和11 - 14岁儿童中显示出低反应原性和高抗原效力，并为不同年龄组的儿童选择了制剂的最佳剂量。免疫接种11个月后，揭示了灭活化学层析流感疫苗在11 - 14岁儿童中具有明显的预防效果，免疫效力指数为1.7。
