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Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in Childhood Immunization

Rotavirus Infection Clinical Trial

Official title:
Multicenter, Prospective, Randomized, Double-blind Placebo-controlled Clinical Study of the Efficacy and Safety of the Vaccine for Prevention of Rotavirus Infection Pentavalent Live With the Participation of Healthy Children

Clinical Trial Summary

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.

Clinical Trial Description

The study is a double-blind placebo-controlled prospective randomized, of efficiency and safety of Vaccine to prevent a rotavirus infection pentavalent live with the participation of healthy children" is carried out in the Russian Federation according to the Protocol of clinical trial No. RTB 003/18, requirements of the national legal system and the international rules of conduct of clinical trials (ICH GCP). The study was randomized of 100 children corresponding to inclusion criteria and not having criteria of non-inclusion, which in the ratio 1:1 were randomized in one of two groups. Children from Group 1 received a vaccine to prevent a rotavirus infection pentavalent live, is triple orally with interval not less than four weeks of 2.5 ml (1 dose). Children from Group 2 received a placebo not less than four weeks of 2.5 ml (1 dose) are triple orally with an interval. Three children (2 persons from Groups 1 and 1 person of Group 2) who were ahead of schedule finished participation in the research were immunized once. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05032391
Study type Interventional
Source Limited Liability Company Pharm Aid
Contact
Status Completed
Phase Phase 3
Start date February 22, 2019
Completion date October 25, 2019
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