CompletedPhase 3

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.

Russia40 participantsStarted 2018-06-25

Plain-language 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).

Who can participate

Age range

18 Years – 45 Years

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

. The signed informed consent;
. Healthy participants, men's and females aged from 18 up to 45 years inclusive;
. Readiness of participants and their sexual partners to use reliable methods of contraception (a combination of at least two modes, including one barrier method, for example, use of a spermicide and condom) from the moment of signing of the informed consent (that is in 3 days before administration of drugs) and before the expiration of 1 month after completion of participation in the study;
. The verified diagnosis "is healthy," established according to collecting the anamnesis and physical inspection:
. The Body Mass Index (BMI) is in normal limits (≥18.5 kg/sq.m and ≤30 kg/sq.m);
. There is a lack of instructions on alcohol abuse or narcotic dependence at the time of inclusion in study or the anamnesis;

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

Geometric Mean Titer (GMT) of antibody

Timeframe: 28 days post-Dose 1

Seroconversion level

Timeframe: 28 days after Dose 1 of vaccine

Seroconversion factor (The increase in the geometric mean antibody titer on day 28 compared to the initial level is expressed in the fold increase.).

Timeframe: 28 days post-Dose 1

Frequency and expressiveness of AE /SAE.

Timeframe: From the time of Dose 1 to 28 days

Trial details

NCT IDNCT05037435

SponsorLimited Liability Company Pharm Aid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-27

View on ClinicalTrials.gov More Rotavirus Infections trials

Who can participate

Age range

18 Years – 45 Years

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

. The signed informed consent;
. Healthy participants, men's and females aged from 18 up to 45 years inclusive;
. Readiness of participants and their sexual partners to use reliable methods of contraception (a combination of at least two modes, including one barrier method, for example, use of a spermicide and condom) from the moment of signing of the informed consent (that is in 3 days before administration of drugs) and before the expiration of 1 month after completion of participation in the study;
. The verified diagnosis "is healthy," established according to collecting the anamnesis and physical inspection:
. The Body Mass Index (BMI) is in normal limits (≥18.5 kg/sq.m and ≤30 kg/sq.m);
. There is a lack of instructions on alcohol abuse or narcotic dependence at the time of inclusion in study or the anamnesis;

What they're measuring

Geometric Mean Titer (GMT) of antibody

Timeframe: 28 days post-Dose 1

Seroconversion level

Timeframe: 28 days after Dose 1 of vaccine

Seroconversion factor (The increase in the geometric mean antibody titer on day 28 compared to the initial level is expressed in the fold increase.).

Timeframe: 28 days post-Dose 1

Frequency and expressiveness of AE /SAE.

Timeframe: From the time of Dose 1 to 28 days

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.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria