PoliomyelitisPhase 4NCT07354269
Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations
A Phase 4 study testing sIPV and DTaP-IPV-Hib in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 3 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 3 months to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- sIPV and DTaP-IPV-Hib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- 26 Sep 2025to 2 May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 3 months to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months;
- 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);
- Provide valid proof of identity;
- Willing and able to comply with all visit schedules, sample collections, vaccinations, and other study procedures, and remain contactable throughout the study period;
- 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.
Who cannot join
- Known history of polio/polio infection.
- 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).
- 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.
- 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).
- Abnormal coagulation function (such as coagulation factor deficiency, platelet abnormalities).
- 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).
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- Severe congenital malformations, genetic defects, and malnutrition.
- 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.
- Acute exacerbations of various acute or chronic diseases within the past 3 days, or known or suspected active infections.
- History of vaccination with any vaccine containing DTP, IPV, Hib components, or pneumococcal polysaccharide conjugate vaccine (applies to infants aged 3 months).
- 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.
- Received immunoglobulin or other blood products within the past 6 months, or plans to receive such treatment during the study.
- Received other investigational drugs or vaccines within the past 30 days, or plans to receive such drugs or vaccines during the study.
- Received live attenuated vaccines, nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.
- 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]).
- Breastfeeding, pregnant, or planning to become pregnant within 3 months after vaccination in this study (applies only to adolescents and adults).
- Axillary temperature >37.0°C before vaccination on the day of the planned vaccination with the study vaccine.
- Unqualified physical examination results on the day of the planned vaccination with the study vaccine.
- Skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with vaccination or observation of local reactions.
- Any other factors deemed unsuitable for participation in the clinical study by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Longxi County Center for Disease Prevention and Control, Dingxi City
Dingxi, Gansu
Junxia zuo, 86-17309356573, 5977503@qq.com
- Recruiting
Chengguan District Center for Disease Prevention and Control, Lanzhou City
Lanzhou, Gansu
huinan wang, 86-18189547063, 1758408205@qq.com
- Recruiting
Zhangye Center for Disease Prevention and Control
Zhangye, Gansu
Li Xiao, 86-18993650826, 375814394@qq.com
About this study
Official title: 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
Read the 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.
- Conditions
- Poliomyelitis
- Being tested
- sIPV, DTaP-IPV-Hib
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sIPVBiological
one dose of sIPV administered via intramuscular injection
DTaP-IPV-HibBiological
three doses of DTaP-IPV-Hib administered via intramuscular injection following the schedule of 3,4,5 months old
| Study group | Role | What they receive |
|---|---|---|
| sIPV group | Experimental | adolescents or adults aged 7-50 years Receives: Biological: sIPV |
| DTaP-IPV-Hib group | Active comparator | infants aged 3 months old Receives: Biological: DTaP-IPV-Hib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 7-17 years
SCR indicates seroconversion rate；nab indicates neutralizing antibody
Measured: 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
SCR indicates seroconversion rate; nab indicates neutralizing antibody
Measured: 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
SCR indicates seroconversion rates; nab indicates neutralizing antibody
Measured: day 30 after the single dose vaccination
Secondary outcomes (10)
The frequency of adverse reactions within 30 days after vaccination in participants aged 7-50 years
Measured: 0-30 days after vaccination
The frequency of SAEs within 30 days after vaccination in participants aged 7-50 years
SAE indicates serious adverse events
Measured: 0-30 days after vaccination
The frequency of adverse reactions within 30 days after vaccination in infants
Measured: 0-30 days after vaccination
The frequency of SAEs within 30 days after vaccination in infants
SAE indicates serious adverse events
Measured: 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
SPR indicates seropositivity rate; PT indicates pertussis toxin
Measured: 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
SCR indicates seroconversion rates; PT indicates pertussis toxin
Measured: 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
SPR indicates seropositivity rate; DT indicates diphtheria toxin
Measured: 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
SCR indicates seroconversion rate； DT indicates diphtheria toxin
Measured: 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
SPR indicates seropositivity rate; TT indicates tetanus toxin
Measured: 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
SCR indicates seroconversion rates; TT indicates tetanus toxin
Measured: day 30 after three doses of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start26 Sep 2025
- Primary completion11 Apr 2026 (estimated)
- Study completion2 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354269
- Sponsor's protocol ID
- PRO-sIPV-4004
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07354269
- Acronym / sponsor ID
- PRO-sIPV-4004
- Conditions
- Poliomyelitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 11 Apr 2026 (estimated)
- Study completion
- 2 May 2026 (estimated)
- First posted
- 21 Jan 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.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sIPV group | Experimental | Biological: sIPVadolescents or adults aged 7-50 years |
| DTaP-IPV-Hib group | Active comparator | Biological: DTaP-IPV-Hibinfants aged 3 months old |
Who may qualify
- Ages
- 3 months to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months;
- 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);
- Provide valid proof of identity;
- Willing and able to comply with all visit schedules, sample collections, vaccinations, and other study procedures, and remain contactable throughout the study period;
- 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.
Key exclusion criteria (20 listed)
- Known history of polio/polio infection.
- 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).
- 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.
- 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).
- Abnormal coagulation function (such as coagulation factor deficiency, platelet abnormalities).
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 |
|---|---|---|
| sIPVone dose of sIPV administered via intramuscular injection | Biological | sIPV group |
| DTaP-IPV-Hibthree doses of DTaP-IPV-Hib administered via intramuscular injection following the schedule of 3,4,5 months old | Biological | DTaP-IPV-Hib group |
Primary outcome
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
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
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
10 secondary outcomes
The frequency of adverse reactions within 30 days after vaccination in participants aged 7-50 years
Time frame: 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
The frequency of adverse reactions within 30 days after vaccination in infants
Time frame: 0-30 days after vaccination
The frequency of SAEs within 30 days after vaccination in infants
Time frame: 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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sIPV and DTaP-IPV-Hib in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 3 sites in China.
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 20 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoshu Zhang (86-0931-8277391, zhxs000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 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 21 Jan 2026.