Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in C… (NCT05032391) | Clinical Trial Compass
CompletedPhase 3
Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in Childhood Immunization
Russia100 participantsStarted 2019-02-22
Plain-language 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.
Who can participate
Age range
60 Days – 70 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.).
Exclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric mean concentration (GMC) of IgA antibodies
Timeframe: From 28 days post-Dose 3 to 1 year of age
2
Seroconversion rate
Timeframe: From 28 days post-Dose 3 to 1 year of age
3
Seroconversion factor
Timeframe: From 28 days post-Dose 3 to 1 year of age
4
Occurrence of unsolicited adverse events
Timeframe: Within the 31 days (Day 0 - Day 30) after the vaccine dose
5
Occurrence of serious adverse events
Timeframe: Within the 31 days (Day 0 - Day 30) after the vaccine dose
. 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;