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AzTrials

Rotavirus InfectionsPhase 3NCT05037435

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.

A Phase 3 study testing The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried) in people with Rotavirus Infections and Rotavirus Vaccines, run by Limited Liability Company Pharm Aid at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Rotavirus Infections, Rotavirus Vaccines
What is being tested?
The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteRussia
Study dates
25 Jun 2018to 27 Jul 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
  • absence in the anamnesis and at the time of screening clinically significant dysfunctions cardiovascular, respiratory, nervous, hemopoietic, endocrine, gastrointestinal systems, liver, and kidneys;
  • absence of persistent infections (HIV, hepatitis B, C, syphilis);
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  • absence within 30 days before inclusion in the study of sharp, infectious diseases;
  • absence of the mental disorders and any other states capable to affectability of the participant to follow requirements of the protocol;
  • lack of complaints to the state of health within 30 days before inclusion in the study;
  • hemodynamic indicators within norm: systolic arterial blood pressure - within 100 - 130 mm Hg., diastolic arterial blood pressure - within 60 - 90 mm Hg;
  • 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;
  • The participant's Ability, according to the study, to fulfill the requirements of the protocol.

Who cannot join

  • The severe vaccine-challenged reactions/complications connected with the previous vaccination;
  • Allergic reactions to components of vaccine or any previous vaccination;
  • Any carried-out vaccination less than in 2 months before the present study;
  • In the chronic anamnesis diseases of the digestive tract, causes intestinal invagination, gastrointestinal pathology, surgical interventions on abdominal organs;
  • Clinically significant deviations of laboratory and tool indicators (including standard pathological changes on the ECG) overstepping the bounds of the range of normal values revealed on screening and capable of negatively impacting the safety of participants of the volunteer in the study;
  • Any diseases within four weeks preceding screening;
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  • Presence of any oncological diseases (including in the anamnesis);
  • Any disease demands continuous therapy, including vegetable drugs or the expected concurrent therapy during the study;
  • Donor blood donation (450 ml of blood or plasma and more) or loss of 500 or more ml of blood in 3 months before the study;
  • Positive analysis on HIV, Hepatitis B and C, and syphilis (RW);
  • Impossibility to give the written informed consent or to follow requirements of the protocol;
  • Probability to refuse to follow the protocol's requirements, instructions and restrictions; for example, unwillingness to cooperate, impossibility to return to clinical center for the subsequent visits, and the probability not of completion of participation in a clinical trial;
  • Participation in clinical trials of drugs less than in 3 months before the study;
  • Smoking more than ten cigarettes in a day;
  • Drug addiction in the anamnesis. The positive analysis of urine on psychotropic and narcotic substances, psychoactive medicines;
  • Regular alcohol intake in many ˃10 units a week (to 1 unit of alcohol is equivalent to ½ l of beer, 200 ml of wine, or 50 ml of hard liquors) or anamnestic data on alcoholism. Alcohol intake within 48 hours before the Screening visit. Positive respiratory test for alcohol on screening (breathalyzer);
  • Observance of a special diet (for example, vegetarian, observance of a post, etc.) or lifestyle (including work at night and extreme physical activities, such as sport or raising of weights) which can interfere with carrying out the study;
  • The study cannot include military personnel or employees law enforcement agencies serving sentences in places of detention or being in custody;
  • The presence of conviction of the study is that the volunteer will not follow procedures of the protocol;
  • Use of any medicines, including OTC, vegetable medicines, dietary supplements, within 14 days before the study, according to the study.

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Perm, 614990

Other trials in Russia

About this study

Official title: Prospective, Randomized, Double-blind, Placebo-controlled Clinical Study of the Safety and Efficacy of the Vaccine for the Prevention of Pentavalent Live Rotavirus Infection in Healthy Subjects (Target Age of 18-45 Years Old).

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).

Read the detailed description

The clinical study named "Prospective, randomized, double-blind, placebo-controlled study of safety and immunological efficacy for preventing a rotavirus infection pentavalent vaccine, live attenuated at the healthy subjects at the age of 18-45 years" was conducted in the Russian Federation. The mentioned study was performed as per Protocol of clinical trial No. RTB 001/18 (given by MOH RF exp June 7, 2018). All relevant requirements of the National Legislative system and the international rules of conduct of clinical trials (ICH GCP).

The study objective was to assess the safety and immunological efficacy for preventing a rotavirus infection pentavalent rotavirus vaccine - Rota-V-Aid™ (live attenuated oral, freeze-dried) at healthy adults aged 18 to 45 years for the subsequent vaccination of the children's contingent.

For the achievement of a goal, it was necessary to solve the following problems:

  1. Assessment of the vaccine's safety for preventing a rotavirus infection pentavalent live compared to placebo at a single oral introduction to volunteers at the age of 18-45 years.
  2. Immunological efficacy assessment for prevention of a rotavirus infection pentavalent live in comparison with placebo at a single oral introduction to volunteers at the age of 18-45 years
Being tested
The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried), Placebo
Medical subject headings
Rotavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Rota-V-Aid™

    Group 1 (20 participants) - received the pentavalent live vaccine to prevent rotavirus infection Single-use orally 2.5 ml (1 dose).

  • PlaceboOther

    Also called Diluent is a sterile solution (Citrate Bicarbonate Buffer)

    Group 2 (20 participants ) - received placebo orally once of 2.5 ml (1 dose).

Study groups in NCT05037435
Study groupRoleWhat they receive
The pentavalent rotavirus vaccine - Rota-V-Aid™ (live attenuated oral, freeze-dried)ExperimentalLive 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.
Receives: Biological: The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)
Diluent is a sterile solution (Citrate Bicarbonate Buffer)Placebo comparatorSame constituents as the active vaccine but without the viral antigens; manufactured by SIIL.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Geometric Mean Titer (GMT) of antibody

    Measured: 28 days post-Dose 1

  2. Seroconversion level

    Measured: 28 days after Dose 1 of vaccine

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

    The seroconversion factor after administration of the study vaccine was 1.20, after administration of placebo - 0.97.

    Measured: 28 days post-Dose 1

  4. Frequency and expressiveness of AE /SAE.

    Measured: From the time of Dose 1 to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2021
  2. Study start25 Jun 2018
  3. Primary completion27 Jul 2018
  4. Study completion27 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized double-blind placebo-controllable.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05037435
Sponsor's protocol ID
RTB 001/18
Status last verified
Aug 2021
First submitted
18 Aug 2021
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried) in people with Rotavirus Infections and Rotavirus Vaccines, run by Limited Liability Company Pharm Aid at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titer (GMT) of antibody (time frame: 28 days post-Dose 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05037435.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.

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