Open AccessReactogenicity, safety and immunological efficacy of the live, pentavalent rotavirus vaccine in childhood immunization (results of the multicenter clinical trial)
Author(s) -
И. В. Фельдблюм,
Ксения Андреевна Субботина,
О.А. Рычкова,
А Н Миронов,
Дарья Александровна Волкова,
Азамат Олегович Метов,
Ирина Вячеславовна Сакаева,
Н. В. Купина,
Михаил Сергеевич Карбышев,
Никита Александрович Миронов,
Ярослава Юрьевна Кондратьева
Publication year - 2020
Publication title -
žurnal mikrobiologii, èpidemiologii i immunobiologii
Language(s) - English
Resource type - Journals
eISSN - 2686-7613
pISSN - 0372-9311
DOI - 10.36233/0372-9311-2020-97-4-9
Subject(s) - reactogenicity , medicine , seroconversion , vaccination , immunization , rotavirus vaccine , pediatrics , clinical trial , rotavirus , immunogenicity , randomized controlled trial , immunology , antibody , virus
. Rotavirus infection (RVI) is the most common cause of severe gastroenteritis in infants and young children worldwide: 600,000 children die annually; it accounts for approximately 3 million hospitalizations and 25 million physician visits each year among children. Preventive vaccination is universally recognized as the most effective measure against this infection.The purpose of the study is assessment of reactogenicity, safety and immunogenicity of the pentavalent live vaccine for RVI prevention in childhood immunization.Materials and methods. The first multicenter prospective, randomized, double-blind, placebo-controlled clinical trial of the pentavalent live vaccine for RVI prevention was conducted in Russia among healthy infants aged 2 months at the time of the first vaccination.Results. The vaccine had a satisfactory safety profile and high immunologic activity when administered in a threedose series for childhood immunization. No negative changes in the children’s health condition were detected during the surveillance monitoring.Discussion. The seroconversion rates, the seroconversion factor and the geometric mean antibody titer were consistent with the results obtained during trials of the above vaccine and its equivalents in other countries.