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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.

NCT05037435 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-09-08

No results posted yet for this study

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).

Conditions

  • Rotavirus Infections
  • Rotavirus Vaccines

Interventions

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).

Sponsors & Collaborators

  • Limited Liability Company Pharm Aid

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-25
Primary Completion
2018-07-27
Completion
2018-07-27

Countries

  • Russia

Study Locations

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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 NCT05037435 on ClinicalTrials.gov