Poliomyelitis VaccinesPhase 1NCT07914244
Clinical Study of the Tolerability, Reactogenicity, and Safety of PoliovacSin in Volunteers Aged 18-60 Years
A Phase 1 study testing Poliomyelitis vaccine in people with Poliomyelitis Vaccines, run by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products at 1 site in Russia.
Trial summary
This is a double-blind, placebo-controlled, randomized, single-center study to evaluate the tolerability, reactogenicity, and safety of the vaccine PoliovakSin in healthy adult volunteers aged 18 to 60 years. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis Vaccines
- What is being tested?
- Poliomyelitis vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 29 Jan 2018to 6 Mar 2018
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers (males and females) aged 18 to 60 years;
- Written informed consent to participate in the clinical trial;
- Ability to comply with protocol requirements (i.e., to complete the Self-Observation Diary and attend follow-up visits);
- Completed poliomyelitis vaccination in accordance with the current National Immunization Schedule;
- For women of childbearing potential: negative pregnancy test and agreement to use adequate contraception methods. Hormonal contraceptives, if used, must be discontinued at least 2 months before the start of the study. All women of childbearing potential must have a negative pregnancy test during the baseline data collection period. Throughout the study, women must use contraception methods with a reliability of more than 90%, or be sterile or postmenopausal. Contraception methods with a typical-use reliability of more than 90% include cervical caps with spermicide, diaphragms with spermicide, condoms, and intrauterine devices.
Who cannot join
- Poliomyelitis revaccination less than 5 years before enrollment;
- Serious post-vaccination reactions/complications associated with previous vaccination;
- Allergic reactions to vaccine components or to any previous vaccination;
- Receipt of any vaccine within one month before the study;
- History of leukemia, malignant neoplasms, or positive test for HIV infection, hepatitis B or hepatitis C;
- Receipt of immunoglobulin preparations or blood transfusion within the last 3 months before the study;
Show all 18Show fewer
- Long-term use (more than 14 days) of immunosuppressants or other immunomodulating drugs within 6 months before the study;
- Any confirmed or suspected immunosuppressive or immunodeficiency condition;
- Chronic diseases of the cardiovascular, bronchopulmonary, gastrointestinal systems, liver, kidneys, or blood in the acute or decompensated stage;
- Progressive neurological disease, convulsive syndrome;
- History of registration at a tuberculosis, substance abuse, neuropsychiatric, or other specialized dispensary;
- Acute infectious disease less than 4 weeks before the study;
- Alcohol consumption of more than 10 units per week, or history of alcoholism, drug addiction, or drug abuse;
- Smoking more than 10 cigarettes per day;
- Participation in any other clinical study within the last 3 months;
- Pregnancy or breastfeeding;
- Serious concomitant diseases or pathological conditions not listed above that, in the Investigator's opinion, could complicate the evaluation of study results, including abnormal blood and urine test values deviating from age-related or laboratory norms that are clinically significant in the Investigator's opinion;
- Any disorder, including laboratory abnormalities, that in the Investigator's opinion exposes the volunteer to unacceptable risk if participating in the study or interferes with the interpretation of study data.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budgetary Healthcare Institution "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency"
Novosibirsk, Novosibirsk Oblast, 630559
About this study
Official title: Double-blind, Placebo-controlled Clinical Study of the Tolerability, Reactogenicity, and Safety of PoliovacSin (Purified, Concentrated, Inactivated Liquid Polio Vaccine Derived From Attenuated Sabin Strains) in Volunteers Aged 18-60 Years
This is a double-blind, placebo-controlled, randomized, single-center study to evaluate the tolerability, reactogenicity, and safety of the vaccine PoliovakSin in healthy adult volunteers aged 18 to 60 years. A total of 60 volunteers who met the eligibility criteria after screening will receive either the PoliovakSin vaccine or a placebo. Participants will be followed for 28 days after vaccination. Safety assessments include physical examination, vital signs, ECG, neurological status, laboratory tests (hematology, blood chemistry, urinalysis, total IgE), monitoring of adverse events and serious adverse events, and a participant self-observation diary. The study will also compare the tolerability, reactogenicity, and safety of the vaccine with those of the placebo.
Read the detailed description
Objective To evaluate the tolerability, reactogenicity, and safety of the vaccine PoliovakSin in healthy volunteers aged 18 to 60 years, and to compare these parameters with placebo.
Study Design This is a double-blind, placebo-controlled, randomized, single-center study. Ninety-nine healthy volunteers signed the informed consent form at the Screening stage. Based on physician examination and laboratory and instrumental assessments, 60 volunteers aged 18 to 60 years were enrolled. Each enrolled participant was assigned a sequential two-digit randomization number, which was retained throughout the study and recorded in the individual case report form. All participants were insured in accordance with the legislation of the Russian Federation.
Screening The screening period did not exceed 5 days before vaccination. Screening procedures included: written informed consent; medical history and concomitant therapy; physical examination (temperature, blood pressure, heart rate, respiratory rate, height, body weight); electrocardiography; blood sampling for HIV, HBsAg, anti-HCV, and syphilis (RW) testing; blood sampling for clinical and biochemical analyses and total IgE; urinalysis; pregnancy test for women of childbearing potential; examination by a physician (therapist); neurological status assessment; evaluation of inclusion/exclusion criteria; and monitoring of adverse events (AEs) and serious adverse events (SAEs). The Screening visit and Visit 1 could be performed on the same day if laboratory results were available within one day or had been obtained within 7 days before Screening.
Vaccination Day and Early Follow-up On the day of vaccination, volunteers were admitted to the clinical site for no more than 24 hours. The investigator examined each volunteer and assessed vital functions. Volunteers who continued to meet the eligibility criteria were vaccinated. Body temperature was measured 10 minutes before and 2 hours after administration of the study product. On the following day, after assessment of vital signs and physical examination, volunteers left the clinic until the next visit.
During the first six days after vaccination, participants attended the clinic for physical examination (temperature, heart rate, blood pressure, respiratory rate), examination by a physician, and monitoring of AEs and SAEs. On Day 3 after vaccination, additional procedures were performed: electrocardiography, blood sampling for clinical and biochemical analyses and total IgE, urinalysis, and neurological status assessment. On Day 7, participants received a self-observation diary and instructions for completing it.
Subsequent Follow-up Participants independently assessed their health and recorded it daily in the self-observation diary for 7 days. At the visit on Day 14 after vaccination, AE and SAE monitoring, blood sampling (biochemical analysis and total IgE), urinalysis, and review of diaries were performed. Participants then continued to record their health status in the diary for another 7 days.
Final Visit At the final visit on Day 28 after vaccination, diaries were collected, and AE and SAE monitoring, physical examination, physician examination, neurological status assessment, blood sampling (clinical and biochemical analyses, total IgE), and urinalysis were performed, after which the study was completed.
Participants were instructed to inform the investigator by telephone or at the nearest clinic visit of any deterioration in health or any adverse events.
- Conditions
- Poliomyelitis Vaccines
- Being tested
- Poliomyelitis vaccine, Placebo comparator (without active ingredient)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poliomyelitis vaccineBiological
A single 0.5 mL intramuscular dose of the Poliomyelitis vaccine was administered to 30 volunteers
Placebo comparator (without active ingredient)Other
A single 0.5 mL intramuscular dose of the Placebo was administered to 30 volunteers
| Study group | Role | What they receive |
|---|---|---|
| Group 1 PolioVacSin | Experimental | Single 0,5 mL dose administered on Day 1 Receives: Biological: Poliomyelitis vaccine |
| Group 2 Placebo | Placebo comparator | Single 0,5 mL dose administered on Day 1 Receives: Other: Placebo comparator (without active ingredient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Vaccination-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of participants experiencing at least one vaccination-related adverse event (AE) or serious adverse event (SAE) graded by severity according to the toxicity scale
Measured: From the day of vaccination up to Day 28
Frequency and Severity of Investigator-Observed Solicited Local and Systemic Adverse Reactions Within 7 Days Post-Vaccination
Percentage of participants with investigator-confirmed solicited local (e.g., pain, redness, swelling at the injection site) and systemic (e.g., fever, headache, fatigue) reactions, classified by severity and relationship to the vaccine
Measured: Day of vaccination (Day 1) and 6 subsequent days (Days 1-7)
Secondary outcomes (13)
Frequency and Severity of Investigator-Observed Solicited Local and Systemic Adverse Reactions on Days 14 and 28
Percentage of participants with investigator-confirmed solicited local and systemic reactions at scheduled follow-up visits
Measured: Day 14 and Day 28
Frequency and Severity of Participant-Reported Solicited Local and Systemic Adverse Reactions
Percentage of participants with self-reported solicited local and systemic reactions recorded in the Patient Diaries, evaluated by severity and relationship to the vaccine
Measured: From Day 8 to Day 27 post-vaccination (total of 21 days of observation)
Change From Baseline in Systolic Blood Pressure
Change in systolic blood pressure (mmHg) at each post-immunization clinic visit compared to the pre-immunization baseline measurement (Day 1)
Measured: Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28
Change From Baseline in Diastolic Blood Pressure
Change in diastolic blood pressure (mmHg) at each post-immunization clinic visit compared to the pre-immunization baseline measurement (Day 1)
Measured: Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28
Change From Baseline in Heart Rate
Change in heart rate (beats per minute) at each post-immunization clinic visit compared to the pre-immunization baseline measurement
Measured: Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28
Change From Baseline in Body Temperature
Change in body temperature (°C) at each post-immunization clinic visit compared to the pre-immunization baseline measurement
Measured: Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Number of participants with new or worsened clinically significant abnormalities on physical examination relative to the pre-immunization baseline, as assessed by the investigator
Measured: Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28
Change From Baseline in Hematology (Complete Blood Count) Parameters
Change from Screening in CBC parameters (hemoglobin, hematocrit, red blood cell count, white blood cell count with differential, platelet count) at Visit 3 (Day 3), Visit 8 (Day 14) and Visit 9 (Day 28). Parameters are reported individually in their standard units.
Measured: Screening, Day 3, Day 14, Day 28
Change From Baseline in Blood Biochemistry Parameters
Change from Screening in biochemistry parameters (e.g., ALT, AST, total bilirubin, creatinine, urea, glucose, total protein) at Day 3, Day 14 and Day 28. Parameters are reported individually in their standard units.
Measured: Screening, Day 3, Day 14, Day 28
Number of Participants With Clinically Significant Abnormalities in Urinalysis
Number of participants with clinically significant abnormal urinalysis findings (e.g., protein, glucose, blood, leukocytes), as assessed by the Investigator, at Day 3, Day 14 and Day 28 compared to Screening
Measured: Day 3, Day 14, Day 28
Change From Baseline in Total Immunoglobulin E (IgE) Level
Change from Screening in serum total IgE at Day 3, Day 14 and Day 28. Unit of Measure: IU/mL (or kU/L)
Measured: Screening, Day 3, Day 14, Day 28
Number of Participants With New or Worsened Abnormal Findings on Neurological Examination Compared With Screening
A standardized neurological examination is performed by the investigator using a structured form covering: level of consciousness, orientation, contact, and meningeal signs; cranial nerves I-XII; motor function (muscle tone, paresis, muscle strength in points, assessed separately on the right and left sides); reflexes (tendon, periosteal, plantar, pathological, oral automatism); superficial and deep sensation; coordination (gait, Romberg test, finger-to-nose and heel-to-shin tests, dysmetria, adiadochokinesis); pelvic functions; and higher mental functions (cognitive decline, aphasia). Findings are recorded as normal or abnormal. The outcome is the number of participants with at least one new or worsened abnormal finding compared with Screening.
Measured: Screening, Visit 1 (Day 1), Visit 3 (Day 3), and Visit 9 (Day 28)
Change from Baseline in Electrocardiogram (ECG) Parameters
Evaluation of changes in ECG parameters (including heart rate, PR, QRS, QT, and QTc intervals) and the emergence of new clinically significant abnormalities compared to the Screening baseline
Measured: Screening and Visit 3 (Day 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start29 Jan 2018
- Primary completion5 Mar 2018
- Study completion6 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poliomyelitis VaccinesStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vladimir Kuzubov, M.D. Ph.D., Principal investigator, Federal State Budgetary Healthcare Institution "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency", Novosibirsk, Novosibirsk 630559
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914244
- Sponsor's protocol ID
- PVS-I-09/17
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 3 Nov 2026
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled Clinical Study of the Tolerability, Reactogenicity, and Safety of PoliovacSin (Purified, Concentrated, Inactivated Liquid Polio Vaccine Derived From Attenuated Sabin Strains) in Volunteers Aged 18-60 Years
- ClinicalTrials.gov ID
- NCT07914244
- Acronym / sponsor ID
- PVS-I-09/17
- Conditions
- Poliomyelitis Vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological ProductsOther government
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 6 Mar 2018 (actual)
- First posted
- 3 Nov 2026 (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.
This is a double-blind, placebo-controlled, randomized, single-center study to evaluate the tolerability, reactogenicity, and safety of the vaccine PoliovakSin in healthy adult volunteers aged 18 to 60 years. A total of 60 volunteers who met the eligibility criteria after screening will receive either the PoliovakSin vaccine or a placebo. Participants will be followed for 28 days after vaccination. Safety assessments include physical examination, vital signs, ECG, neurological status, laboratory tests (hematology, blood chemistry, urinalysis, total IgE), monitoring of adverse events and serious adverse events, and a participant self-observation diary. The study will also compare the tolerability, reactogenicity, and safety of the vaccine with those of the placebo.
Detailed description
Objective To evaluate the tolerability, reactogenicity, and safety of the vaccine PoliovakSin in healthy volunteers aged 18 to 60 years, and to compare these parameters with placebo.
Study Design This is a double-blind, placebo-controlled, randomized, single-center study. Ninety-nine healthy volunteers signed the informed consent form at the Screening stage. Based on physician examination and laboratory and instrumental assessments, 60 volunteers aged 18 to 60 years were enrolled. Each enrolled participant was assigned a sequential two-digit randomization number, which was retained throughout the study and recorded in the individual case report form. All participants were insured in accordance with the legislation of the Russian Federation.
Screening The screening period did not exceed 5 days before vaccination. Screening procedures included: written informed consent; medical history and concomitant therapy; physical examination (temperature, blood pressure, heart rate, respiratory rate, height, body weight); electrocardiography; blood sampling for HIV, HBsAg, anti-HCV, and syphilis (RW) testing; blood sampling for clinical and biochemical analyses and total IgE; urinalysis; pregnancy test for women of childbearing potential; examination by a physician (therapist); neurological status assessment; evaluation of inclusion/exclusion criteria; and monitoring of adverse events (AEs) and serious adverse events (SAEs). The Screening visit and Visit 1 could be performed on the same day if laboratory results were available within one day or had been obtained within 7 days before Screening.
Vaccination Day and Early Follow-up On the day of vaccination, volunteers were admitted to the clinical site for no more than 24 hours. The investigator examined each volunteer and assessed vital functions. Volunteers who continued to meet the eligibility criteria were vaccinated. Body temperature was measured 10 minutes before and 2 hours after administration of the study product. On the following day, after assessment of vital signs and physical examination, volunteers left the clinic until the next visit.
During the first six days after vaccination, participants attended the clinic for physical examination (temperature, heart rate, blood pressure, respiratory rate), examination by a physician, and monitoring of AEs and SAEs. On Day 3 after vaccination, additional procedures were performed: electrocardiography, blood sampling for clinical and biochemical analyses and total IgE, urinalysis, and neurological status assessment. On Day 7, participants received a self-observation diary and instructions for completing it.
Subsequent Follow-up Participants independently assessed their health and recorded it daily in the self-observation diary for 7 days. At the visit on Day 14 after vaccination, AE and SAE monitoring, blood sampling (biochemical analysis and total IgE), urinalysis, and review of diaries were performed. Participants then continued to record their health status in the diary for another 7 days.
Final Visit At the final visit on Day 28 after vaccination, diaries were collected, and AE and SAE monitoring, physical examination, physician examination, neurological status assessment, blood sampling (clinical and biochemical analyses, total IgE), and urinalysis were performed, after which the study was completed.
Participants were instructed to inform the investigator by telephone or at the nearest clinic visit of any deterioration in health or any adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 PolioVacSin | Experimental | Biological: Poliomyelitis vaccineSingle 0,5 mL dose administered on Day 1 |
| Group 2 Placebo | Placebo comparator | Other: Placebo comparator (without active ingredient)Single 0,5 mL dose administered on Day 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy volunteers (males and females) aged 18 to 60 years;
- Written informed consent to participate in the clinical trial;
- Ability to comply with protocol requirements (i.e., to complete the Self-Observation Diary and attend follow-up visits);
- Completed poliomyelitis vaccination in accordance with the current National Immunization Schedule;
- For women of childbearing potential: negative pregnancy test and agreement to use adequate contraception methods. Hormonal contraceptives, if used, must be discontinued at least 2 months before the start of the study. All women of childbearing potential must have a negative pregnancy test during the baseline data collection period. Throughout the study, women must use contraception methods with a reliability of more than 90%, or be sterile or postmenopausal. Contraception methods with a typical-use reliability of more than 90% include cervical caps with spermicide, diaphragms with spermicide, condoms, and intrauterine devices.
Key exclusion criteria (18 listed)
- Poliomyelitis revaccination less than 5 years before enrollment;
- Serious post-vaccination reactions/complications associated with previous vaccination;
- Allergic reactions to vaccine components or to any previous vaccination;
- Receipt of any vaccine within one month before the study;
- History of leukemia, malignant neoplasms, or positive test for HIV infection, hepatitis B or hepatitis C;
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 |
|---|---|---|
| Poliomyelitis vaccineA single 0.5 mL intramuscular dose of the Poliomyelitis vaccine was administered to 30 volunteers | Biological | Group 1 PolioVacSin |
| Placebo comparator (without active ingredient)A single 0.5 mL intramuscular dose of the Placebo was administered to 30 volunteers | Other | Group 2 Placebo |
Primary outcome
Incidence of Vaccination-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the day of vaccination up to Day 28
Percentage of participants experiencing at least one vaccination-related adverse event (AE) or serious adverse event (SAE) graded by severity according to the toxicity scale
Frequency and Severity of Investigator-Observed Solicited Local and Systemic Adverse Reactions Within 7 Days Post-Vaccination
Time frame: Day of vaccination (Day 1) and 6 subsequent days (Days 1-7)
Percentage of participants with investigator-confirmed solicited local (e.g., pain, redness, swelling at the injection site) and systemic (e.g., fever, headache, fatigue) reactions, classified by severity and relationship to the vaccine
13 secondary outcomes
Frequency and Severity of Investigator-Observed Solicited Local and Systemic Adverse Reactions on Days 14 and 28
Time frame: Day 14 and Day 28
Frequency and Severity of Participant-Reported Solicited Local and Systemic Adverse Reactions
Time frame: From Day 8 to Day 27 post-vaccination (total of 21 days of observation)
Change From Baseline in Systolic Blood Pressure
Time frame: Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28
Change From Baseline in Diastolic Blood Pressure
Time frame: Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28
Change From Baseline in Heart Rate
Time frame: Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28
Change From Baseline in Body Temperature
Time frame: Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Time frame: Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28
Change From Baseline in Hematology (Complete Blood Count) Parameters
Time frame: Screening, Day 3, Day 14, Day 28
Change From Baseline in Blood Biochemistry Parameters
Time frame: Screening, Day 3, Day 14, Day 28
Number of Participants With Clinically Significant Abnormalities in Urinalysis
Time frame: Day 3, Day 14, Day 28
Change From Baseline in Total Immunoglobulin E (IgE) Level
Time frame: Screening, Day 3, Day 14, Day 28
Number of Participants With New or Worsened Abnormal Findings on Neurological Examination Compared With Screening
Time frame: Screening, Visit 1 (Day 1), Visit 3 (Day 3), and Visit 9 (Day 28)
Change from Baseline in Electrocardiogram (ECG) Parameters
Time frame: Screening and Visit 3 (Day 3)
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 3 Nov 2026.
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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.
Vladimir Kuzubov, M.D. Ph.D. principal investigator
Federal State Budgetary Healthcare Institution "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency", Novosibirsk, Novosibirsk 630559
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Poliomyelitis vaccine in people with Poliomyelitis Vaccines, run by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products 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 5 inclusion and 18 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 3 Nov 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Vaccination-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From the day of vaccination up to Day 28). The study lists 2 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 3 Nov 2026.