Clinical trial Recruiting at 3 sites Phase 4 Interventional Ages 3 Months to 50

One-dose Sabin inactivated polio vaccine (sIPV) in adolescents and adults versus three-dose DTaP‑IPV‑Hib in infants

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

Run by Sinovac Biotech Co., Ltd · NCT07354269 · Data updated 2026-11-12

This will try one dose of Sabin inactivated poliovirus vaccine (sIPV) in people aged 7–50 to see if it gives similar antibody protection and safety as three doses of DTaP‑IPV‑Hib given to infants.

More Poliomyelitis trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages3 Months to 50 Years
SexAll
Enrollment180 (estimated)
SponsorSinovac Biotech Co., Ltd
Industry-sponsored
Drugs / interventionsprednisone
Locations3 sites (Dingxi, Gansu and 2 other locations)
StatusRecruiting
StartedSeptember 26, 2025
Main results expectedApril 11, 2026
Study endsMay 2, 2026
Registry record updatedJanuary 21, 2026
Trial IDNCT07354269 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy infants aged 3 months, adolescents aged 7–17, or adults aged 18–50 who can provide valid ID, give informed consent (or have guardian consent), comply with visits and sampling, and agree to required contraception if fertile.

Probably not a fit

People with a prior history of polio infection, those outside the specified age ranges, or individuals with medical conditions that prevent vaccination are unlikely to receive benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, open-label, controlled Phase IV study will enroll 180 healthy participants in three cohorts: 60 infants (3 months), 60 adolescents (7–17 years), and 60 adults (18–50 years). Adolescents and adults receive a single sIPV dose on Day 0 while infants receive three doses of DTaP‑IPV‑Hib at months 3, 4, and 5; blood is collected before vaccination and about 30 days after the last vaccination to measure antibody responses. Safety monitoring includes 30-minute on-site observation after vaccination, diary cards for solicited and unsolicited adverse events through Day 7 and Day 30, and collection of serious adverse events through Day 30 after the last dose. Pregnancy and fertility-related events are tracked and fertile participants must agree to contraceptive measures during the study period.

Why it matters

Potential benefit: If successful, the approach could show that a single sIPV dose for older children and adults provides comparable protection with fewer injections and simpler logistics.

How similar studies have gone: Sabin-strain IPV formulations have shown immunogenicity in prior trials, but directly comparing one-dose sIPV in older patients to a three-dose pentavalent infant schedule is less commonly tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

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

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.