A Phase 1 interventional study of Poliomyelitis vaccine and Placebo comparator (without active ingredient) in Poliomyelitis Vaccines, sponsored by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products. Completed at 1 site in Russia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products · Phase 1, Interventional, and Prevention
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.
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.
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Single 0,5 mL dose administered on Day 1
Biological: Poliomyelitis vaccine
Single 0,5 mL dose administered on Day 1
Other: Placebo comparator (without active ingredient)
A single 0.5 mL intramuscular dose of the Poliomyelitis vaccine was administered to 30 volunteers
A single 0.5 mL intramuscular dose of the Placebo was administered to 30 volunteers
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
Time frame: 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
Time frame: Day of vaccination (Day 1) and 6 subsequent days (Days 1-7)
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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
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
Number of participants with new or worsened clinically significant abnormalities on physical examination relative to the pre-immunization baseline, as assessed by the investigator
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: Screening and Visit 3 (Day 3)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products