Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Completed NCT03207750 - This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine Phase 3
Completed NCT00895492 - Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile N/A
Completed NCT01266850 - Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules Phase 4
Completed NCT02992197 - The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity Phase 4
Completed NCT00981877 - Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children N/A
Active, not recruiting NCT02662543 - The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children After Introduction of Rotavirus Vaccines N/A
Completed NCT00302640 - Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children Phase 2/Phase 3
Active, not recruiting NCT04626856 - Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection Phase 1
Completed NCT01764256 - A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine Phase 1
Completed NCT00880698 - Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers Phase 2
Completed NCT01328925 - Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children Phase 2
Completed NCT00683982 - Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus N/A
Completed NCT01511133 - Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™ N/A