Rotavirus InfectionPhase 3NCT05032391
Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in Childhood Immunization
A Phase 3 study testing The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried) in people with Rotavirus Infection, run by Limited Liability Company Pharm Aid at 2 sites in Russia.
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. Read more about this study
- Who is it for?
- Ages 60 to 70 daysHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infection
- What is being tested?
- The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesRussia
- Study dates
- 22 Feb 2019to 25 Oct 2019
- 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 60 to 70 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.).
Who cannot join
- 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;
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- 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;
- In the researcher's opinion, the child is not eligible for inclusion in the study, or the researcher is convinced that the parent / adoptive parent will not follow the Protocol's procedures;
- Continuous use (more than 14 days from birth until inclusion in the study) of immunosuppressants or immunomodulators;
- Continuous use (more than 14 days from birth until inclusion in the study) of steroid drugs at a dose of more than 0.5 mg/kg/day in terms of prednisone. The use of topical or inhaled steroids is permitted;
- 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 );
- Administration of immunoglobulins or blood components from birth until inclusion and their planned administration during the study.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Perm State Medical University named after Academician E.A. Wagner
Perm, 614990
Tyumen State Medical University
Tyumen, 625023
About this study
Official title: Multicenter, Prospective, Randomized, Double-blind Placebo-controlled Clinical Study of the Efficacy and Safety of the Vaccine for Prevention of Rotavirus Infection Pentavalent Live With the Participation of Healthy Children
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.
Read the detailed 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.
- Conditions
- Rotavirus Infection
- Being tested
- The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried), Placebo
- Keywords
- rotavirus vaccine
- 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™
Three times orally in a volume of 2.5 ml (1 dose)
PlaceboDrug
Also called Diluent is a sterile solution (Citrate Bicarbonate Buffer)
Three times orally in a volume of 2.5 ml (1 dose)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within the 31 days (Day 0 - Day 30) after the vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start22 Feb 2019
- Primary completion22 Sep 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Multicenter, prospective, randomized double-blind, placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Limited Liability Company Pharm Aid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irina V. Feldblium, PhD, Study director, Perm State Medical University named after Academician E.A. WagnerOlga A. Rychkova, Dr. Sci, Study director, Tyumen State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032391
- Sponsor's protocol ID
- RTV 003/18
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Randomized, Double-blind Placebo-controlled Clinical Study of the Efficacy and Safety of the Vaccine for Prevention of Rotavirus Infection Pentavalent Live With the Participation of Healthy Children
- ClinicalTrials.gov ID
- NCT05032391
- Acronym / sponsor ID
- RTV 003/18
- Conditions
- Rotavirus Infection
- Keywords
- rotavirus vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Limited Liability Company Pharm AidUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 22 Sep 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Multicenter, prospective, randomized double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried) | Experimental | Biological: The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)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. |
| Diluent is a sterile solution (Citrate Bicarbonate Buffer) | Placebo comparator | Drug: PlaceboSame constituents as the active vaccine but without the viral antigens; manufactured by SIIL. |
Who may qualify
- Ages
- 60 to 70 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.).
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)Also: Rota-V-Aid™Three times orally in a volume of 2.5 ml (1 dose) | Biological | The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried) |
| PlaceboAlso: Diluent is a sterile solution (Citrate Bicarbonate Buffer)Three times orally in a volume of 2.5 ml (1 dose) | Drug | Diluent is a sterile solution (Citrate Bicarbonate Buffer) |
Primary outcome
Geometric mean concentration (GMC) of IgA antibodies
Time frame: From 28 days post-Dose 3 to 1 year of age
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.
Seroconversion rate
Time frame: From 28 days post-Dose 3 to 1 year of age
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.
Seroconversion factor
Time frame: From 28 days post-Dose 3 to 1 year of age
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.
Occurrence of unsolicited adverse events
Time frame: Within the 31 days (Day 0 - Day 30) after the vaccine dose
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.
Occurrence of serious adverse events
Time frame: Within the 31 days (Day 0 - Day 30) after the vaccine dose
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irina V. Feldblium, PhD study director
Perm State Medical University named after Academician E.A. Wagner
Olga A. Rychkova, Dr. Sci study director
Tyumen State Medical University
2 sites in 1 country: see every site and its status.
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 Infection, run by Limited Liability Company Pharm Aid at 2 sites 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 5 inclusion and 19 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 5 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 2 sites 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 concentration (GMC) of IgA antibodies (time frame: From 28 days post-Dose 3 to 1 year of age). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2021.