NCT05037435

Safety and Immunological Efficacy of the Pentavalent Rotavirus Vaccine - Rota-V-Aid™ (Live Attenuated Oral, Freeze-dried) at Healthy Adults Aged 18 to 45 Years.

Prospective, Randomized, Double-blind, Placebo-controlled Clinical Study of the Safety and Efficacy of the Vaccine for the Prevention of Pentavalent Live Rotavirus Infection in Healthy Subjects (Target Age of 18-45 Years Old).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Limited Liability Company Pharm Aid · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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

Conditions

• Rotavirus Infections
• Rotavirus Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)	Group 1 (20 participants) - received the pentavalent live vaccine to prevent rotavirus infection Single-use orally 2.5 ml (1 dose).
OTHER	Placebo	Group 2 (20 participants ) - received placebo orally once of 2.5 ml (1 dose).

Timeline

• Start date: 2018-06-25
• Primary completion: 2018-07-27
• Completion: 2018-07-27
• First posted: 2021-09-08
• Last updated: 2021-09-08

Locations

1 site across 1 country: Russia