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

NCT05032391 | Completed Phase 3

• 1 other identifier: RTV 003/18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

rotavirus vaccine

Outcome Measures

Primary Outcomes (5)

• Geometric mean concentration (GMC) of IgA antibodies

  Increased number of specific antibodies IgA after threefold administration of HPV in the 1st group was statistically significantly different from the diversity of the increase in IgA level in the placebo group.

  From 28 days post-Dose 3 to 1 year of age

• Seroconversion rate

  Seroconversion rate (with two, three, and quadruple antibody increases) in the Group those grafted with the study drug ranged from 79.17% to 83.33%, with data values of effectiveness indicator of the studied Vaccine for prevention rotavirus infection statistically significantly exceeded levels seroconversion in children from the Placebo Group.

  From 28 days post-Dose 3 to 1 year of age

• Seroconversion factor

  The multiplicity of the increase in antibody HRT in the Vaccine Group was 39.05, in the Pla cebo Group -2,80. This indicator in the Vaccine Vaccinated Group is also statistically significant exceeded the seroconversion factor in the Placebo Group.

  From 28 days post-Dose 3 to 1 year of age

• Occurrence of unsolicited adverse events

  The association with the study product had 44 adverse events (22 adverse events in study participants from Group 1 and 22 adverse events in study participants from Group 2). All adverse events that had a connection with taking the test product, were recorded within the first 7 days after immunization and were a manifestation of reactogenicity.

  Within the 31 days (Day 0 - Day 30) after the vaccine dose

• Occurrence of serious adverse events

  No history has been detected since severe post-vaccine reactions/complications related to the previous vaccination, allergic reactions to vaccine components, or any prior immunization.

  Within the 31 days (Day 0 - Day 30) after the vaccine dose

Study Arms (2)

The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)

EXPERIMENTAL

Live attenuated bovine-human \[UK\] reassortant rotavirus vaccine manufactured by the Serum Institute of India, Limited (SIIL). The pentavalent vaccine contains rotavirus serotypes G1, G2, G3, G4, and G9 (≥5.6 log10 FFU/serotype/dose). The vaccine is lyophilized and supplied with 2.5 ml of citrate bicarbonate buffer added for reconstitution before oral administration.

Biological: The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)

Diluent is a sterile solution (Citrate Bicarbonate Buffer)

PLACEBO COMPARATOR

Same constituents as the active vaccine but without the viral antigens; manufactured by SIIL.

Drug: Placebo

Interventions

The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried) BIOLOGICAL

Three times orally in a volume of 2.5 ml (1 dose)

Also known as: Rota-V-Aid™

The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)

Placebo DRUG

Three times orally in a volume of 2.5 ml (1 dose)

Also known as: Diluent is a sterile solution (Citrate Bicarbonate Buffer)

Diluent is a sterile solution (Citrate Bicarbonate Buffer)

Eligibility Criteria

• Age: 60 Days - 70 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male or female children at the age of 2 months at the time of the first vaccination with PI / PS, vaccinated according to age by the schedule of the National Calendar of Preventive Vaccinations of the Russian Federation;
• Baby should be ≥ 37 weeks gestational age and birth weight ≥ 2500 g;
• Children who do not have contraindications for vaccination (by the Protocol, according to medical history and clinical examination);
• An Informed Consent Form for participation in the research, voluntarily and personally signed by the parent / adoptive parent of the child, before any of the research procedures;
• Ability, in the researcher's opinion, of the parents / adoptive parents of the child to comply with the requirements of the Protocol (attendance of all scheduled Visits, completion of the Child Observation Diary, etc.).

You may not qualify if:

• Orphans (except for officially adopted children) and children without parental care;
• Child's gestational age \<37 weeks and birth weight \<2500 g;
• Participation in any other clinical study;
• Received or planned vaccination with any other rotavirus vaccine before enrollment in this study;
• A history of diarrhea or blood in the stool or a violation of bowel movements in the last 14 days;
• A history of chronic diseases of the gastrointestinal tract, history of intussusception of the intestine and congenital malformations of the gastrointestinal tract, predisposing to it, surgery on the abdominal organs;
• Known sensitivity or allergy to any of the PI and PS components;
• Serious post-vaccination reactions/complications disorders/defects associated with any previous vaccinations;
• Any significant systemic disease (from the lungs, liver, kidneys, skin, cardiovascular system, gastrointestinal tract, endocrine system, immune system, nervous system, and cancer or autoimmune disease) that would jeopardize children's health or result in non-compliance with the Protocol;
• Congenital or genetic disorders/defects;
• Clinically significant abnormalities in laboratory parameters that go beyond the limits of the normal range identified at the Screening and may have a negative impact on the safety of the child's participation in the study;
• Household contact with immunocompromised people or with an immunocompromised pregnant woman;
• A history of proven hepatitis B, diphtheria, tetanus, whooping cough, poliomyelitis, hemophilic or pneumococcal infection;
• Confirmed or suspected immunodeficiency condition (based on medical history);
• Hereditary or congenital immunodeficiency (according to family history );

Sponsors & Collaborators

• Limited Liability Company Pharm Aid: lead

Study Sites (2)

Perm State Medical University named after Academician E.A. Wagner

Perm, 614990, Russia

Location

Tyumen State Medical University

Tyumen, 625023, Russia

Location

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Freeze Drying

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Cryopreservation; Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Study Officials

• Irina V. Feldblium, PhD

  Perm State Medical University named after Academician E.A. Wagner

  STUDY DIRECTOR

• Olga A. Rychkova, Dr. Sci

  Tyumen State Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The present study was a double-blind, placebo-controlled study, i.e., neither the investigator nor the parent / adoptive parent of the child knew which particular drug was administered to a particular study participant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, prospective, randomized double-blind, placebo-controlled

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 2, 2021
• Study Start: February 22, 2019
• Primary Completion: September 22, 2019
• Study Completion: October 25, 2019
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

RU (2)