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

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

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.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 3 Months to 50 Years
• Sex: All
• Sponsor: Sinovac Biotech Co., Ltd (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 3 sites (Dingxi, Gansu and 2 other locations)
• Trial ID: NCT07354269 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Dingxi, Gansu and 2 other locations

• 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

• Study coordinator: Xiaoshu Zhang

Conditions Poliomyelitis