Actively Recruiting
An Open-labelled, Randomized, Controlled Trial to Evaluate Immunogenicity and Safety of Sequential Sabin and Wild Strain Inactivated Poliovirus Vaccine
Led by Sinovac Biotech Co., Ltd · Updated on 2026-03-09
480
Participants Needed
3
Research Sites
5 weeks
Total Duration
On this page
Sponsors
S
Sinovac Biotech Co., Ltd
Lead Sponsor
A
Aga Khan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing the immune response and safety of the Sabin strain and wild strain inactivated poliovirus vaccines sIPV and wIPV given by two different injection methods in healthy infants. This phase IV trial involves 480 infants aged 56 to 84 days and aims to assess which vaccination schedule and injection route produce better immunity and safety profiles. The study is randomized and open-label, focusing on immunogenicity and tolerability of sequential vaccination regimens. Participants are randomly assigned into four groups receiving different sequences of three doses of poliovirus vaccine at 28-day intervals, with some receiving the vaccines intramuscularly and others subcutaneously. The four vaccination regimens include combinations of wIPV and sIPV doses. Each group has two-thirds of infants receiving injections into the muscle and one-third receiving injections under the skin. During the study, infants will be observed for immediate reactions for 30 minutes after each vaccine dose, and guardians will record adverse events for 28 days post-vaccination. Blood samples will be collected before the first dose and about 28 days after the final dose to measure antibodies against poliovirus types. Mothers will also provide blood samples or pregnancy test results to screen for infections that could affect the infant. Researchers will track immune response and safety outcomes throughout the trial, which ends in October 2026.
CONDITIONS
Brief Title
Phase IV Clinical Study of Sequential Vaccination of Sabin Strain and Wild Strain Inactivated Poliovirus Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants aged 56 to 84 days
- Parent or legal guardian has provided written informed consent
- Able to provide vaccination records since birth
- Infant's mother tested negative for HIV, syphilis, hepatitis B, and hepatitis C during or before enrollment
You will not qualify if you...
- History of any polio vaccination
- Severe allergic reaction to previous vaccinations or vaccine components
- Born before 37 weeks of gestation
- History of asphyxia rescue or nervous system injury
- Congenital malformations, developmental disorders, significant genetic defects, or severe malnutrition
- Autoimmune diseases or immunodeficiency/immunosuppression
- Serious chronic diseases such as Down's syndrome, diabetes, sickle cell anemia, or neurological disorders
- Abnormal blood clotting functions or platelet disorders
- Received immunosuppressants (excluding topical or inhaled corticosteroids), cytotoxic drugs, or other immunomodulatory therapies
- Received blood products before vaccination
- 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 illness or worsening of chronic illness within 7 days before enrollment
- Significant acute diseases, chronic infections, or fever (≥ 37.5°C) before enrollment
- Any other factors deemed unsuitable by investigators
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here