NCT07457060 Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine
| NCT ID | NCT07457060 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sinovac Biotech Co., Ltd |
| Condition | Poliomyelitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2025-11-27 |
| Primary Completion | 2026-09-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 480 participants in total. It began in 2025-11-27 with a primary completion date of 2026-09-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes
Eligibility Criteria
Inclusion Criteria: 1. Infants of 2 months old (aged 56-84 days). 2. Have a parent/legal guardian who has provided written informed consent after being fully informed about the study. 3. Be able to provide the vaccination records since birth. 4. The infant's mother is tested negative for HIV, syphilis, hepatitis B, and hepatitis C during or before the infant's enrollment to this study (test results obtained during pregnancy are acceptable, if provided). Exclusion Criteria: 1. History of any polio vaccination. 2. History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component. 3. Premature infants (born before week 37 of gestation). 4. History of asphyxia rescue or nervous system injury. 5. Congenital malformations, developmental disorders, clinically significant genetic defects, severe malnutrition. 6. Autoimmune diseases or immunodeficiency/immunosuppression. 7. Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders. 8. Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders). 9. Received immunosuppressant (excluding topical or inhaled corticosteroids), cytotoxic drug, or other immunomodulatory therapies. 10. Received blood products before trial vaccine inoculation. 11. Received other study drugs within 30 days before enrollment. 12. Received live attenuated vaccines within 14 days before enrollment. 13. Received subunit or inactivated vaccines within 7 days before enrollment. 14. Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment. 15. Significant acute diseases, chronic infections, or axillary temperature ≥ 37.5°C before enrollment. 16. Any other factors deemed by the investigators as unsuitable for participation.
Frequently Asked Questions
Who can join the NCT07457060 clinical trial?
This trial is open to participants of all sexes, aged 56 Days or older, up to 84 Days, studying Poliomyelitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07457060 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07457060 currently recruiting?
Yes, NCT07457060 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sinovac Biotech Co., Ltd to inquire about joining.
Where is the NCT07457060 trial being conducted?
This trial is being conducted at Kawit, Philippines, Iloilo City, Philippines, Imus, Philippines.
Who is sponsoring the NCT07457060 clinical trial?
NCT07457060 is sponsored by Sinovac Biotech Co., Ltd. The trial plans to enroll 480 participants.