NCT05032391

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Limited Liability Company Pharm Aid · Academic / Other
• Sex: All
• Age: 60 Days – 70 Days
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Rotavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)	Three times orally in a volume of 2.5 ml (1 dose)
DRUG	Placebo	Three times orally in a volume of 2.5 ml (1 dose)

Timeline

• Start date: 2019-02-22
• Primary completion: 2019-09-22
• Completion: 2019-10-25
• First posted: 2021-09-02
• Last updated: 2021-09-05

Locations

2 sites across 1 country: Russia