The purpose of the presented study was to evaluate the safety and immunological efficacy in preventing the rotavirus infection within a cohort of healthy subjects (target age of 18-45 years old) by using the pentavalent rotavirus vaccine - Rota-V-Aid™ (live attenuated oral, freeze-dried).
The clinical study named "Prospective, randomized, double-blind, placebo-controlled study of safety and immunological efficacy for preventing a rotavirus infection pentavalent vaccine, live attenuated at the healthy subjects at the age of 18-45 years" was conducted in the Russian Federation. The mentioned study was performed as per Protocol of clinical trial No. RTB 001/18 (given by MOH RF exp June 7, 2018). All relevant requirements of the National Legislative system and the international rules of conduct of clinical trials (ICH GCP). The study objective was to assess the safety and immunological efficacy for preventing a rotavirus infection pentavalent rotavirus vaccine - Rota-V-Aid™ (live attenuated oral, freeze-dried) at healthy adults aged 18 to 45 years for the subsequent vaccination of the children's contingent. For the achievement of a goal, it was necessary to solve the following problems: 1. Assessment of the vaccine's safety for preventing a rotavirus infection pentavalent live compared to placebo at a single oral introduction to volunteers at the age of 18-45 years. 2. Immunological efficacy assessment for prevention of a rotavirus infection pentavalent live in comparison with placebo at a single oral introduction to volunteers at the age of 18-45 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
40
Group 1 (20 participants) - received the pentavalent live vaccine to prevent rotavirus infection Single-use orally 2.5 ml (1 dose).
Group 2 (20 participants ) - received placebo orally once of 2.5 ml (1 dose).
Perm State Medical University named after Academician E.A. Wagner
Perm, Russia
Geometric Mean Titer (GMT) of antibody
Time frame: 28 days post-Dose 1
Seroconversion level
Time frame: 28 days after Dose 1 of vaccine
Seroconversion factor (The increase in the geometric mean antibody titer on day 28 compared to the initial level is expressed in the fold increase.).
The seroconversion factor after administration of the study vaccine was 1.20, after administration of placebo - 0.97.
Time frame: 28 days post-Dose 1
Frequency and expressiveness of AE /SAE.
Time frame: From the time of Dose 1 to 28 days
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