Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations

January 14, 2026 updated by: Sinovac Biotech Co., Ltd

Phase IV Clinical Study Comparing the Immunogenicity and Safety of a Single-dose Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains (sIPV) in Adolescents and Adults Aged 7-50 Years Versus the Primary Immunization With DTaP-IPV-Hib Pentavalent Vaccine in Infants Aged 3 Months

The goal of this clinical study is to compare the immunogenicity and safety of one dose of sIPV in adolescents or adults aged 7-50 years with that of three doses of DTaP-IPV-Hib Pentavalent Vaccine in Infants Aged 3 Months

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study adopts a single-center, open-label, controlled design, planning to recruit 180 healthy participants, including 60 adolescents aged 7-17 years, 60 adults aged 18-50 years, and 60 infants aged 3 months. After being screened and enrolled, adolescents and adults aged 7-50 years will receive one dose of sIPV (inactivated poliovirus vaccine, Sabin strain) on Day 0, while infants aged 3 months will receive three doses of the pentavalent vaccine (DTaP-IPV-Hib) at 3, 4, and 5 months of age. Approximately 2.5-3.0 milliliters of venous blood will be collected from all participants before vaccination and on Day 30 after the last vaccination for antibody testing and immunogenicity evaluation. Researchers will observe participants for adverse events (AEs) within 30 minutes post-vaccination on-site and use diary cards to collect solicited and unsolicited AEs from Day 0 to Day 7 and AEs from Day 8 to Day 30 post-vaccination. Additionally, serious adverse events (SAEs) will be collected from the start of the first vaccination until Day 30 after the last vaccination. For fertile participants, pregnancy events for female participants themselves or the partners of male participants aged 18-50 years will be collected during the study period and after the first vaccination through a combination of active follow-up by researchers and self-reporting by participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Gansu
      • Dingxi, Gansu, China
        • Recruiting
        • Longxi County Center for Disease Prevention and Control, Dingxi City
        • Contact:
      • Lanzhou, Gansu, China
        • Recruiting
        • Chengguan District Center for Disease Prevention and Control, Lanzhou City
        • Contact:
      • Zhangye, Gansu, China
        • Recruiting
        • Zhangye Center for Disease Prevention and Control
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months;
  2. Participants and/or their guardians are able to understand and voluntarily sign the informed consent form (for participants aged 7-17 years, both the participant and their guardian need to sign);
  3. Provide valid proof of identity;
  4. Willing and able to comply with all visit schedules, sample collections, vaccinations, and other study procedures, and remain contactable throughout the study period;
  5. Fertile participants and their sexual partners voluntarily adopt effective contraceptive measures from the signing of the informed consent form until 3 months after vaccination with the study vaccine, and have no plans to donate sperm or eggs.

Exclusion Criteria:

  1. Known history of polio/polio infection.
  2. Exposure or suspected exposure to pertussis, diphtheria, and tetanus within the past 30 days, such as having a confirmed case of pertussis or diphtheria in the household (applies to infants aged 3 months).
  3. History of uncontrolled chronic or severe illnesses, including but not limited to cardiovascular disease, hematological disorders, liver and kidney diseases, digestive system diseases, respiratory diseases, malignant tumors, and history of major organ transplantation.
  4. Presence of autoimmune diseases, immunodeficiency disorders (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).
  5. Abnormal coagulation function (such as coagulation factor deficiency, platelet abnormalities).
  6. Premature birth (delivery before the 37th week of gestation) or low birth weight (birth weight <2500g), or history of asphyxiation, or history of neurological damage (applies to infants aged 3 months).
  7. Severe congenital malformations, genetic defects, and malnutrition.
  8. Current or past history of severe neurological diseases (epilepsy, convulsions or seizures [excluding a history of febrile seizures]) or psychiatric disorders, or family history of psychiatric disorders.
  9. Acute exacerbations of various acute or chronic diseases within the past 3 days, or known or suspected active infections.
  10. History of vaccination with any vaccine containing DTP, IPV, Hib components, or pneumococcal polysaccharide conjugate vaccine (applies to infants aged 3 months).
  11. Received immunosuppressive or other immunomodulatory treatment for ≥14 days within the past 6 months (≥20mg/day of prednisone for those ≥18 years old, ≥2mg/kg/day for those <18 years old, or equivalent doses), cytotoxic treatment, or plans to receive such treatment during the study.
  12. Received immunoglobulin or other blood products within the past 6 months, or plans to receive such treatment during the study.
  13. Received other investigational drugs or vaccines within the past 30 days, or plans to receive such drugs or vaccines during the study.
  14. Received live attenuated vaccines, nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.
  15. Known allergy to any component of the study vaccine (inactivated poliovirus, 199 medium, glycine, sodium chloride, potassium chloride, calcium chloride, magnesium phosphate, disodium phosphate, monosodium phosphate [for adolescents and adults]; inactivated poliovirus, diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous hemagglutinin, Haemophilus influenzae type b capsular polysaccharide, tetanus protein conjugate [for infants aged 3 months]).
  16. Breastfeeding, pregnant, or planning to become pregnant within 3 months after vaccination in this study (applies only to adolescents and adults).
  17. Axillary temperature >37.0°C before vaccination on the day of the planned vaccination with the study vaccine.
  18. Unqualified physical examination results on the day of the planned vaccination with the study vaccine.
  19. Skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with vaccination or observation of local reactions.
  20. Any other factors deemed unsuitable for participation in the clinical study by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: sIPV group
adolescents or adults aged 7-50 years
Biological: sIPV
one dose of sIPV administered via intramuscular injection
Active Comparator: DTaP-IPV-Hib group
infants aged 3 months old
Biological: DTaP-IPV-Hib
three doses of DTaP-IPV-Hib administered via intramuscular injection following the schedule of 3,4,5 months old

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 7-17 years
Time Frame: day 30 after the single dose vaccination
SCR indicates seroconversion rate；nab indicates neutralizing antibody
day 30 after the single dose vaccination
The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 18-50 years
Time Frame: day 30 after the single dose vaccination
SCR indicates seroconversion rate; nab indicates neutralizing antibody
day 30 after the single dose vaccination
The SCR of nab against three serotypes of polioviruses at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
Time Frame: day 30 after the single dose vaccination
SCR indicates seroconversion rates; nab indicates neutralizing antibody
day 30 after the single dose vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The frequency of adverse reactions within 30 days after vaccination in participants aged 7-50 years
Time Frame: 0-30 days after vaccination
0-30 days after vaccination
The frequency of SAEs within 30 days after vaccination in participants aged 7-50 years
Time Frame: 0-30 days after vaccination
SAE indicates serious adverse events
0-30 days after vaccination
The frequency of adverse reactions within 30 days after vaccination in infants
Time Frame: 0-30 days after vaccination
0-30 days after vaccination
The frequency of SAEs within 30 days after vaccination in infants
Time Frame: 0-30 days after vaccination
SAE indicates serious adverse events
0-30 days after vaccination
The SPR of antibody against PT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
Time Frame: day 30 after three doses of vaccination
SPR indicates seropositivity rate; PT indicates pertussis toxin
day 30 after three doses of vaccination
The SCR of antibody against PT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
Time Frame: day 30 after three doses of vaccination
SCR indicates seroconversion rates; PT indicates pertussis toxin
day 30 after three doses of vaccination
The SPR of antibddy against DT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
Time Frame: day 30 after three doses of vaccination
SPR indicates seropositivity rate; DT indicates diphtheria toxin
day 30 after three doses of vaccination
The SCR of antibody against DT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
Time Frame: day 30 after three doses of vaccination
SCR indicates seroconversion rate； DT indicates diphtheria toxin
day 30 after three doses of vaccination
The SPR of antibody against TT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
Time Frame: day 30 after three doses of vaccination
SPR indicates seropositivity rate; TT indicates tetanus toxin
day 30 after three doses of vaccination
The SCR of antibody against TT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months
Time Frame: day 30 after three doses of vaccination
SCR indicates seroconversion rates; TT indicates tetanus toxin
day 30 after three doses of vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac Biotech Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-sIPV-4004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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