Trial · NCT07914244
Clinical Study of the Tolerability, Reactogenicity, and Safety of PoliovacSin in Volunteers Aged 18-60 Years
NCT07914244, Phase 1, Completed, Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Clinical Study of the Tolerability, Reactogenicity, and Safety of PoliovacSin in Volunteers Aged 18-60 Years. Trials, record NCT07914244. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07914244
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study of the Tolerability, Reactogenicity, and Safety of PoliovacSin in Volunteers Aged 18-60 Years
- NCT number
- NCT07914244
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 60 participants, actual
- Lead sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
- Conditions
- Poliomyelitis Vaccines
- Interventions
- Poliomyelitis vaccine, Placebo comparator (without active ingredient)
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Vaccination-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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 |
| Primary | Frequency and Severity of Investigator-Observed Solicited Local and Systemic Adverse Reactions Within 7 Days Post-Vaccination | 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 |
| Secondary | Frequency and Severity of Investigator-Observed Solicited Local and Systemic Adverse Reactions on Days 14 and 28 | Day 14 and Day 28 | Percentage of participants with investigator-confirmed solicited local and systemic reactions at scheduled follow-up visits |
| Secondary | Frequency and Severity of Participant-Reported Solicited Local and Systemic Adverse Reactions | From Day 8 to Day 27 post-vaccination (total of 21 days of observation) | Percentage of participants with self-reported solicited local and systemic reactions recorded in the Patient Diaries, evaluated by severity and relationship to the vaccine |
| Secondary | Change From Baseline in Systolic Blood Pressure | Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28 | Change in systolic blood pressure (mmHg) at each post-immunization clinic visit compared to the pre-immunization baseline measurement (Day 1) |
| Secondary | Change From Baseline in Diastolic Blood Pressure | Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28 | Change in diastolic blood pressure (mmHg) at each post-immunization clinic visit compared to the pre-immunization baseline measurement (Day 1) |
| Secondary | Change From Baseline in Heart Rate | Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28 | Change in heart rate (beats per minute) at each post-immunization clinic visit compared to the pre-immunization baseline measurement |
| Secondary | Change From Baseline in Body Temperature | Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28 | Change in body temperature (°C) at each post-immunization clinic visit compared to the pre-immunization baseline measurement |
| Secondary | Number of Participants With Clinically Significant Abnormal Physical Examination Findings | Pre-immunization (Day 1) baseline; Days 1-7, Day 14, and Day 28 | Number of participants with new or worsened clinically significant abnormalities on physical examination relative to the pre-immunization baseline, as assessed by the investigator |
| Secondary | Change From Baseline in Hematology (Complete Blood Count) Parameters | Screening, Day 3, Day 14, Day 28 | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07914244
GET https://conductscience.org/api/trials/v1/NCT07914244/registered