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New treatment option for Poliomyelitis
Official title Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine
ClinicalTrials.gov ID: NCT07457060
What this study is testing
What is 2wIPV+1sIPV?
2wIPV+1sIPV is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for poliomyelitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to compare the immunogenicity and safety of sIPV administered via subcutaneous and intramuscular injection routes
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 56 to 84. Healthy volunteers may be eligible.
You may be able to join if
- Infants of 2 months old (aged 56-84 days).
- Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
- Be able to provide the vaccination records since birth.
- 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...
You likely can't join if
- History of any polio vaccination.
- History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component.
- Premature infants (born before week 37 of gestation).
- History of asphyxia rescue or nervous system injury.
- Congenital malformations, developmental disorders, clinically significant genetic defects, severe malnutrition.
- Autoimmune diseases or immunodeficiency/immunosuppression.
See the full eligibility criteria
- Infants of 2 months old (aged 56-84 days).
- Have a parent/legal guardian who has provided written informed consent after being fully informed about the study.
- Be able to provide the vaccination records since birth.
- 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).
- History of any polio vaccination.
- History of severe allergic reaction to previous vaccinations or hypersensitivity to any vaccine component.
- Premature infants (born before week 37 of gestation).
- History of asphyxia rescue or nervous system injury.
- Congenital malformations, developmental disorders, clinically significant genetic defects, severe malnutrition.
- Autoimmune diseases or immunodeficiency/immunosuppression.
- Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders.
- Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders).
- Received immunosuppressant (excluding topical or inhaled corticosteroids), cytotoxic drug, or other immunomodulatory therapies.
- Received blood products before trial vaccine inoculation.
- Received other study drugs within 30 days before enrollment.
- Received live attenuated vaccines within 14 days before enrollment.
- Received subunit or inactivated vaccines within 7 days before enrollment.
- Acute diseases or acute exacerbations of chronic diseases within 7 days before enrollment.
- Significant acute diseases, chronic infections, or axillary temperature ≥ 37.5°C before enrollment.
- Any other factors deemed by the investigators as unsuitable for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Kawit, Cavite, Philippines
- Iloilo City, Philippines
- Imus, Philippines
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 56 days to 84 days. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kawit, Cavite, Philippines; Iloilo City, Philippines; Imus, Philippines. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.