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

NCT05032391 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-09-05

No results posted yet for this study

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.

Conditions

  • Rotavirus Infection

Interventions

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)

Sponsors & Collaborators

  • Limited Liability Company Pharm Aid

    lead OTHER

Principal Investigators

  • Irina V. Feldblium, PhD · Perm State Medical University named after Academician E.A. Wagner

  • Olga A. Rychkova, Dr. Sci · Tyumen State Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Days
Max Age
70 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2019-09-22
Completion
2019-10-25

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05032391 on ClinicalTrials.gov