Sequential vaccination with Sabin-strain and wild-strain inactivated polio vaccines

Is this trial a fit for you?

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

What this trial studies

This open-label, randomized, controlled Phase IV trial will enroll 480 healthy infants aged 56–84 days and randomize them equally into four vaccination regimens: 2wIPV+1sIPV, 1wIPV+2sIPV, 3wIPV, and 3sIPV, with 28-day intervals between doses. Within each regimen, two-thirds of participants will receive injections intramuscularly and one-third subcutaneously to compare injection routes. Blood samples taken before the first vaccination and 28 days after the last vaccination will measure neutralizing antibody titers against the three poliovirus serotypes, and safety monitoring will include immediate observation, guardian diary cards for solicited and unsolicited adverse events, and collection of serious adverse events up to 28 days after the final dose. The trial is open-label and uses standardized procedures for immunogenicity and safety data collection.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centennial Clindev Research and Development of Medical Sciences
  Kawit, Cavite, Philippines Recruiting
• Iloilo Doctors' Hospital
  Iloilo City, Philippines Recruiting
• Health Index Multispecialty Clinic - Research and Development on Medical Sciences
  Imus, Philippines Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.